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EPAAC WP8 Pilot Project 1 “European cancer research coordination in early phase clinical research” Update Objectives of PP1 The purpose of PP1 is to design and fund state-of-the-art biomarker-driven phases I/II academic clinical trials on investigational drugs so as to accelerate the development of new treatments or new therapeutic use of existing treatments. This project endeavors to spur access to innovative molecules for patients in the framework of early-phase academic trials. PP1 is modeled from the French national CLIP² program and the UK Alliance program. The development of this pilot case comprises the following main steps: 1) The grant of designation, in each participating European countries, of centres of excellence in early phase clinical research, with access to molecular biology infrastructures; 2) The constitution of a European network with the above designated expert centres to allow potential clinical trial designs to be discussed and developed jointly; 3) The development of relationship with the pharmaceutical industries to gain access to innovative therapeutics. It is expected that the proposed above organisational framework will help integrate clinical research and biology into the decisional process and facilitate the evolution of stratified medicine in Europe. PP1 will focus on new applications of original compounds in rare cancers or outside the company’s own development plan, including novel combination therapies. In terms of coordination pathway, PP1 is about combining and/or expanding innovative national programs that have proven track records. Main achievements & steps with regard PP1 developments - Research Forum (Brussels, July 2012): agreement across the participants that the two suggested pilot coordination areas (early phase clinical research and outcome research) should be pursued, and that prevention and public health research, another highly relevant and important area, should be prioritized for another pilot coordination project - Follow-up workshop (Paris, October 2012): discussion among leading research funding organizations about the proposed coordination modalities. An overview of the French CLIP² programme, the UK Alliance programme and various other national initiatives was provided. The program’s steps and pre-requisites (designation of expert centres, funding models, etc.) were reviewed in light of existing European initiatives. Participants agree that PP1 should focus on new therapies for unmet medical needs, where collaboration is essential to reach critical mass of patients. The idea of opening up existing national networks to collaboration with other countries across Europe was viewed as particularly

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Page 1: EPAAC WP8 Pilot Project 1 European cancer research ... · EPAAC WP8 Pilot Project 1 “European cancer research coordination in early phase clinical research” Update Objectives

EPAAC WP8 Pilot Project 1

“European cancer research coordination in early phase clinical research”

Update

Objectives of PP1 The purpose of PP1 is to design and fund state-of-the-art biomarker-driven phases I/II academic clinical trials on investigational drugs so as to accelerate the development of new treatments or new therapeutic use of existing treatments. This project endeavors to spur access to innovative molecules for patients in the framework of early-phase academic trials. PP1 is modeled from the French national CLIP² program and the UK Alliance program. The development of this pilot case comprises the following main steps:

1) The grant of designation, in each participating European countries, of centres of excellence in early phase clinical research, with access to molecular biology infrastructures; 2) The constitution of a European network with the above designated expert centres to allow potential clinical trial designs to be discussed and developed jointly; 3) The development of relationship with the pharmaceutical industries to gain access to innovative therapeutics.

It is expected that the proposed above organisational framework will help integrate clinical research and biology into the decisional process and facilitate the evolution of stratified medicine in Europe. PP1 will focus on new applications of original compounds in rare cancers or outside the company’s own development plan, including novel combination therapies.

In terms of coordination pathway, PP1 is about combining and/or expanding innovative national programs that have proven track records.

Main achievements & steps with regard PP1 developments

- Research Forum (Brussels, July 2012): agreement across the participants that the two suggested pilot coordination areas (early phase clinical research and outcome research) should be pursued, and that prevention and public health research, another highly relevant and important area, should be prioritized for another pilot coordination project

- Follow-up workshop (Paris, October 2012): discussion among leading research funding organizations about the proposed coordination modalities. An overview of the French CLIP² programme, the UK Alliance programme and various other national initiatives was provided. The program’s steps and pre-requisites (designation of expert centres, funding models, etc.) were reviewed in light of existing European initiatives. Participants agree that PP1 should focus on new therapies for unmet medical needs, where collaboration is essential to reach critical mass of patients. The idea of opening up existing national networks to collaboration with other countries across Europe was viewed as particularly

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attractive. It was decided that at its outset, PP1 should assess the feasibility of linking the UK and French programmes.

-

Document Acrobat sur J__EUROPE_SANCO EPAAC_WP 8 Recherche_Meetings_Meeting Madrid_PP1 update and Madrid meeting report 092013.docx.pdf

- Follow-up meeting (Valencia, April 2013): a detailed review of both the CLIP² and the Alliance program’ steps was done during the meeting by the lead organizations of both programs. The designation phase of the expert centers was not considered at this stage, since the purpose is to use the existing organizational framework as they are and coordinate the programs, not to harmonize their procedures. It appears feasible, despite some discrepancies in the respective process, to coordinate both programs and launch joint calls for transnational multi-center studies across the UK and French networks. Alternative coordination options were suggested like opening pre-selected studies submitted by the UK centres in the Alliance program to the French CLIP² cooperation and vice versa. It was decided to exchange key paperwork related to both programs (MoU, agreements, and call documents) and that INCa would be invited to attend the next Alliance’s joint steering committee in May 2013.

- INCa’s representative attended the NCRN/ECMC/AstraZeneca Alliance Symposium (May 2013, London): this annual symposium represents an important milestone of the Alliance program. Preselected clinical studies projects are presented by the investigators in front of the evaluation panel (with pharmaceutical and ECMC/NCRN committee’s representatives).

- Presentation of PP1 at the TRANSCAN meetings (Athens, June 2013): the state of PP1 development was presented in front of the TRANSCAN members in June 2013.

Representatives of the Dutch cancer society confirmed their interest to join PP1 and a meeting was planed between INCa and the Dutch Cancer Society in July to share detailed information on the CLIP² program and its potential expansion in Netherland.

- Bilateral meeting organised between INCa and the Dutch Cancer society (Paris, July 2013): representatives from the Dutch Cancer Society came to INCa to review in detail the CLIP² program steps and discuss how to join PP1. The meeting was followed by an exchange of key CLIP² program documents, including criteria used for the designation of expert centres.

- Presentation of PP1 during working meetings with pharmaceutical leaders by INCa: Inca has explored the potential interest of various pharmaceutical companies, already involved in the CLIP² program, for a CLIP²-like program at European level. In particular, the following laboratories have expressed their potential interest: Novartis, Pfizer, Astra Zeneca, Roche. Some of them attended and actively participated to the Research Forum and follow-up meetings organised in the frame of EPAAC WP8.

- Research workshop (Madrid, September 2013): discussion among leading research funding organizations about the proposed coordination modalities. 3 complementary options have arisen from the discussion, which will be pursued in parallel. See below for full report.

Next steps (beyond EPAAC) - INCa will continue to pursue both development paths : 1) combination of CLIP² and Alliance

programs and 2) expansion of CLIP² program with the countries that have expressed an interest (Italy and Netherland) to show the feasibility of PP1

- A meeting is planned with representative of the Italian ministry of health in December, with a specific focus on PP1 and PP2

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- With regard the combination of the CLIP² and Alliance program, the next steps relate to the launch of a joint call for collaborative proposals across both networks, targeting rare cancer tumors (sarcoma) or rare molecular subtypes, with Astra Zeneca portfolio of therapeutic agents. Astra Zeneca is currently involved in both programs and has expressed a strong interest for PP1.

- INCa will explore the interest of pharmaceutical companies involved in the CLIP² program and already aware of PP1 to open their molecule portfolio for cross company combination studies (current combination studies are done with chemotherapy or RT)

- INCa will explore the feasibility to introduce an amendment in its current CLIP² agreements with pharmaceutical companies to include the participation of other European centers of excellence. May not be feasible before 2015, after the designation of eligible centres based on

quality control and data magagement.Netherland has already expressed its interest to join a CLIP²-like program. Same with Italy. Spanish centers of excellence could be included in the program with private funding.

- INCa will work with the Italian Ministry of Health and the Dutch Cancer Society towards the above goal.

- INCa will organize a workshop in 2014 with potential expert centers and funders in IT and NL to develop a join program

Future - To run the pilot with few countries & show the feasibility and added value of the network - To work with IMI2 as a platform to get access to cross company libraries of molecules &

perform cross company combination studies of targeted molecules. - To advance on molecular profiling of relapsing tumors or on mechanisms of resistance to

treatments

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Annex1 Research Workshop, 13th September 2013

Instituto de Salud Carlos III, Madrid Meeting report

Attendees: Christine BERLING, INCa, France Béatrice BUSSIERE, INCa, France Antoine ITALIANO, Institut Bergonié-Bordeaux, France Philippe CASSIER, Centre Léon Bérard-Lyon, France Eric ANGEVIN, Institut Gustave Roussy-Villejuif, France Wouter EIJGELAAR, KWF Kankerbestrijding, Netherlands Clare SHAW, NCRN, United Kingdom Robert WILLIAMS, ECMC, CR UK, United Kingdom Miguel QUINTELA-FANDIÑO , CNIO, Spain Antonio LÓPEZ, CNIO, Spain PP1 breakout session agenda and presentations 9:45 Update on Pilot Project 1 and objectives of the day Christine Berling (INCa, France)

10:05 Short presentation of France CLIP² program/status of the partnership & molecule

portfolio Béatrice Bussière (INCa, France)

10:20 Short presentation of UK Alliance program Clare Shaw / Robert Williams (NCRN/CR UK; ECMC, UK)

10:35 General discussion/similarities and discrepancies of the respective programs Main points addressed:

Combination on rare diseases: as phase 1 studies usually require few participating sites, EU collaboration has added value on rare disease, when number of patients in a particular country is not sufficient. Study on CTC (circulating tumor cells), characterization of circulating DNA, biomarkers studies: this kind of study is not possible for one site, need of a network with few clinical sites.

PK studies need to be centralized: how standardize the process, is a centralized procedure needed? At a national level?

Phase I or later stage studies Sponsorship of studies across Europe (IGR confirms capabilities) View of Astra Zeneca which is currently involved in the two programs How to keep coordination & review as simple as possible

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Strong interest for brokering cross company combination studies (currently studies involve targeted compound in combination with chemotherapy or RT)

11:00 Coffee break 11:15 Presentation by each of the French CLIP² center representative (with a particular focus of

their area of expertise, the current studies under the CLIP² program and their vision of the UK/French coordination

Eric Angevin (Institut Gustave Roussy, France) Philippe Cassier (Centre Léon Bérard, France) Antoine Italiano (Institut Bergonié, France)

11:45 Discussion & first recommendations for linking both programs

Main points addressed: Getting access to molecule portfolio is the key issue in most studies/ added value

of the network Should aim at studies on molecular profiling of relapsing tumors or on

mechanisms of resistance to targeted therapies with large portfolio of molecules (molecular profiling of patients/ would help select the best class of compounds)

May need to have disease specific trial to identify the resistance mechanism 2014 : renewal of the designation of the CLIP² centers 2015 : renewal of the designation of the NCRN centres

Recommendations for the combination of the CLIP² and Alliance program: To open a call for proposals across both networks Indication : a rare cancer tumor (sarcoma, where links exist already) or rare molecular

subtypes Need to involve a translational program To approach Astra Zeneca (Astra Zeneca is currently involved in both programs and has

expressed a strong interest for PP1) – UK representatives to speak to AZ during the Alliance next steering committee of October

12:45 Lunch 14:15 Short presentation of the Dutch KWF Kankerbestrijding Wouter EIJGELAAR (KWFK, NL)

14:30 General discussion & potential collaboration

Main points addressed: Currently no government funded cancer research program/ Funding can be done

by the Dutch Cancer Society should be ready in 2015 once the evaluation of capacities of the Dutch clinical

trials groups is finished Issue is to set up the quality control & data management procedures most interested to connect to the existing french CLIP² Program/ joint proposal

could be developed by the NL & FR centers Large phase I centers in NL located in the 8 university medical sites

14:50 Short presentation of the Centro Nacional de Investigaciones Oncológicas

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Miguel Quintela-Fandiño (CNIO, Spain) Antonio López (CNIO, Spain) 15:05 General discussion & potential collaboration

Main points addressed: The CNIO is a structure that performs translational research, it is organized in

different units, these units have connections with clinical research units of hospitals to perform clinical trials. CNIO is often the sponsor.

CNIO is partially funded by the government with 20 M€/year, projects are funded by pharmas or public calls. They have units where they perform drug development.

CNIO was ranked among the top 10 cancer research institutes in 2009 15:30 End of PP1 breakout session

Conclusions and action plan:

1) To open a joint call for collaborative proposals across both UK and France networks on rare disease (sarcoma) or rare molecular subtype. Collaborative proposals between the UK and the FR sites would be required. Need to approach Astra Zeneca (UK will take this action during the next Alliance steering committee.

2) Inca should explore the interest of pharmaceutical companies already involved in the CLIP² program to open their molecule portfolio for cross company combination studies

3) Introduce an amendment to the current CLIP² agreements to include the participation of centers from NL and Spain. May not be feasible before 2015, after the designation of eligible centres based on quality control and data magagement.

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EPAAC WP8 Research Workshop, 13th September 2013

PP2 Parallel session – Summary report

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EPAAC WP8 Research Workshop, 13th September 2013

Instituto de Salud Carlos III, Madrid

Pilot Project 2 “A European Platform for Cancer Outcomes Research”

Parallel session

Summary report

Background

Objectives of Pilot Project 2 The EPAAC WP8 Pilot Project 2 (PP2) aims at the establishment of a platform for cancer outcomes research

at the European level. Generally speaking, the ultimate goal of outcomes research is to assess the end

results of healthcare practices and interventions both on individual patients and populations. The specific

objectives of cancer outcomes research are: to describe, interpret, and predict the impact of interventions

and other factors (socio-economic, organisational, technological, and behavioural) on ’final’ outcomes

(survival, disease-free survival, quality of life, perceptions and satisfaction related to healthcare, cost-

effectiveness). Therefore, cancer outcomes research can well be considered an integral part of translational

research, aimed at integrating early, i.e. basic/pre-clinical, translational research, clinical research, and late

(clinical) translational research in order to speed up the application of novel products, tools and approaches

in healthcare systems.

The specific objectives of PP2 are: i) overcoming the lack of information in current databases; ii) integrating

population-based cancer registry data with clinical data derived from clinical sets and biobanks to explain

the differences in survival across areas and over time; iii) overcoming the differences in clinical treatment

patterns across countries; iv) evaluating the effectiveness of new treatments as well as of treatments

recommended by guidelines. The PP2 objective in the intermediate term is to test the feasibility of

obtaining multicentre outcomes research measures based on a commonly standardised methodology.

Moving towards PP2: steps taken and main achievements

EPAAC WP8 questionnaires: the consultation of the scientific community and policy makers on

identification and prioritisation of areas in cancer research identified the implementation of a European

platform for cancer outcomes research as a priority.

Interaction between EPAAC WP8 - Research and WP9 – Information: elaboration of a concept paper for

PP2.

EPAAC WP8 Research Forum (Brussels, July 2012): the PP2 concept paper was presented in a panel

discussion with funders, researchers, clinicians, patients, industry, public health experts and policy makers.

A general agreement was reached on the importance of pursuing the PP2.

Follow-up workshop (Paris, October 2012): the concept behind PP2 was further elaborated between

experts, by discussing concrete steps towards the implementation and design of a tentative roadmap. A

consensus opinion was expressed on the following considerations:

• Currently, despite the development and validation of outcome measures in the context of the

health services research area, standardised tools or methodologies for assessing the impact of

interventions and other factors (socio-economic, organisational, technological, and behavioural) on

final cancer outcomes are not applied at a pan-European level.

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• This gap represents an obstacle to the: i) decision-making process, impeding the objective

evaluation (benefit for the subjects/patients and cost-effectiveness) especially of new agents and

strategies for cancer prevention, diagnosis/early detection, treatment and palliation; and ii)

definition of a cancer research agenda intended to generate better scientific products and

information, as well as to optimise the quality of cancer care through an evidence-based decision-

making process.

It was therefore decided to proceed with the definition of PP2 specific objectives, tasks, and activities. To

this end, a draft document was then elaborated in preparation of the follow-up meeting planned to be held

in Valencia in April 2013. In parallel, the above mentioned concept paper was further refined and

distributed in preparation of the Valencia meeting (see document “EPAAC WP8 Pilot Project 2_Concept

Paper”).

Follow-up meeting (Valencia, April 2013): in this restricted meeting of the PP2 “core” group, represented by

the Istituto Superiore di Sanità, the National Cancer Institute in Milan, Italy and the EurocanPlatform

Network of Excellence (funded by the European Commission under the 7th

Framework Programme), the

above mentioned draft document focused on the definition of objectives, tasks, activities, and possible

implementation measures for PP2 was discussed and further refined. As a result, a proposal was elaborated

for the PP2 strategy (objectives, main tasks and related activities) and methodology, and identification of

potential leaders for the various tasks (see document “European Cancer Research Outcomes

Platform_strategy and methodology”).

Presentation of PP2 at the TRANSCAN meetings (Athens, June 2013): the state of PP2 development, as of

the Valencia meeting, was presented to the funding organisations partnering in the ERA-NET on

Translational Cancer Research TRANSCAN.

EPAAC WP8 Research workshop (Madrid, September 2013): The PP2 parallel session in the EPAAC WP8

workshop held in Madrid had the main objective of consolidating the PP2 proposal by defining the details,

in terms of structure, objectives and activities and delineating the steps needed for PP2 implementation,

through the discussion with selected experts, previously identified as potential participants in the different

activities. The main outcomes are reported in the following section.

PP2 developments during and following the EPAAC WP8 Workshop in Madrid

The participants in the PP2 parallel session held during the workshop in Madrid (see document

“PP2_parallel session_draft agenda”) commonly agreed that, at the light of recent improvements in cancer

diagnosis and treatment, the establishment of an European Platform for Cancer Outcomes Research would

allow to investigate and compare the adherence to clinical recommendations, as well as the dissemination

and impact of novel treatments in population-based set of patients, in relation to internationally agreed

guidelines. As an example, those which are now being developed for breast cancer in the JRC initiative

“Voluntary accreditation scheme for breast cancer services and further development of European breast

cancer guidelines”. Similar JRC initiatives are envisaged for colorectal and other cancers.

The key objectives and activities for the PP2 implementation, as outlined in the document “European

Cancer Research Outcomes Platform_strategy and methodology”, were illustrated by the task leaders and

discussed with the audience, as summarised below.

Clinical Cancer Registries (see presentation < EPAAC WP8 PP2_Task 1_Ringborg_Madrid_13092013 >. This

task refers to the development of a methodology for: i) collecting information on the impact of diagnostic

tools, treatment and intensity of follow-up on outcome, based on effectiveness (i.e. effects on population-

based patient cohorts) and definition of outcome indicators; ii) obtaining comprehensive clinical cancer

registries, including treatment of recurrent disease. These activities and objectives are of crucial

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importance to overcome the current lack of information on the impact of anti-cancer therapies on the

outcome in most countries. Currently, assumptions on the effects of anti-cancer therapies are usually based

on results from clinical trials i.e. on the clinical efficacy. In contrast, detailed data on clinical effectiveness

are needed, i.e. effects of therapeutic interventions on a population based patient cohort, particularly in

the case of new therapies, to demonstrate effects of innovations for the patients: cure, survival and quality

of life. In addition, data on clinical effectiveness are a prerequisite for assessment of cost-effectiveness.

The establishment of a platform of clinical cancer registries for outcomes research and clinical

epidemiology is the ultimate goal of the EurocanPlatform WP11, http://eurocanplatform.eu) chaired by

Hermann Brenner, Cornelia Ulrich, Adam Gondos and Petra Schrotz-King (DKFZ and NCT, Heidelberg,

Germany). The WP11 is currently focused on the compilation of comprehensive clinical cancer registries in

selected cancer types, by collecting detailed information on the patient’s characteristics, tumour data,

primary treatment, treatment of recurrent disease, outcomes of treatments (individual treatments as well

as integration of the complete clinical pathway), and follow-up.

The operational and functional link of these WP11 activities with the PP2 task aimed at linking population-

based and clinical cancer registries is a pre-requisite and a cornerstone for the building of a European

cancer outcomes research platform.

Linking Population-based and Clinical Registries (see presentation < EPAAC WP8 PP2_Task

2_Capocaccia_Madrid_13092013 >). This task refers to the development of a methodology for optimising

and harmonising/standardising the process of collection, linking, sharing and analysis of cancer data

between quality assured patient registries and population based registries, with particular attention to

assuring quality and comparability of data. The rationale of this task is based on the need of optimising the

use of data collected in population-based and clinical cancer registries to allow the evaluation of the impact

of cancer care activities on public health impact and measurement of their outcome. The task activities will

be implemented by building on the previous experience, such as that developed in the EUROCARE,

EUROCOURSE, EurocanPlatform, ENCR projects, among others. Possible procedures to be adopted, as well

as indicators and outcomes to be selected and further defined, were presented and discussed. Their

detailed definition as well as a roadmap for the next steps is currently under preparation in close

interaction with the EurocanPlatform WP11.

High Resolution Studies (see presentation < EPAAC WP8 PP2_Task 3_Sant_Madrid_13092013 >. This task

aims at the design, based on clinical sets of data, of new High Resolution Studies (HRS) in selected cancers.

The importance of HRS for the assessment of cancer care outcomes has been already demonstrated by the

EUROCARE project, that has repeatedly documented large inequalities in cancer survival across European

countries and highlighted many inter-country variations. As an outcome of the EUROCARE studies, actions

aimed at reducing disparities and improving the outcome of care for cancer patients have been already

implemented. To better understand the functional importance of HRS in the context of a European

platform for cancer outcomes research, it should be noted that different approaches can be adopted to

evaluate the outcome of cancer care, and namely:

• National vs international studies: standardized tools or methodologies on cancer outcomes for

assessing the impact of interventions and other factors (socioeconomic, organizational, technological,

and behavioral) are applied mainly at national level, and their impact is difficult to interpret across

countries due to the scarce comparability of data collected by different institutions.

• Population vs hospital-based studies: clinical registries are useful to identify outcomes of clinical

relevance in the group of patients cured in an hospital (or in a group of hospitals). However databases

based on all the patients cured in a specific hospital not always can be generalized to the whole

patient population, as patients referring to a specific hospital may be selected , for example, according

to socioeconomic conditions or disease characteristics, or other confounders. To avoid these selection

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biases, it is necessary to perform studies on patients (or samples of patients) representative of the

whole incidence set, for instance random samples from population-based cancer registries, as in HRS.

Past experiences of HRS proved that a networking of European cancer registries represent an effective

outcome research tool at a European level. Through the collection of information on patterns of care and

follow-up data, in more detail than in the usual registry activity, HRS can contribute to implement a system

for timely monitoring the adherence to clinical guidelines (for instance the European guidelines now being

developed). While the short time objective of new HRS is to monitor timely adherence to clinical guidelines,

a long term objective is to study survival and disease-free survival and the influence of patterns of care on

prognosis. This action should however be based on a systematic and continuous collection of data by the

population cancer registries included in the network. Beside conventional outcomes, such as survival or

disease-free survival, other types of outcomes as quality of life (QoL) and health economy-related issues

can be investigated. Of note, a number of European population-based cancer registries have already

expressed their interest in carrying out HRS, aimed to investigate: i) the dissemination and the impact of

new treatments in population-based set of patients; ii) frequency of and variation in adherence to standard

care; iii) the reasons for differences in survival; iv) the reasons for overtime changes in survival for

advanced stage disease. (Note: the EPAAC WP9 organised on 25-26th September 2013 the 2nd European

High Resolution Workshop at the JRC premises in Ispra with cancer registries and clinicians from 11 EU

countries to define a protocol for a New European HRS on Breast, Colorectal, Lung, Melanoma to investigate

and compare patterns of care, comorbidity and adherence to internationally agreed clinical guidelines for

diagnosis and treatment for these cancers, and set the basis for updating follow-up and diagnosis of

relapses or subsequent tumors, if any, to estimate survival and disease-free survival. As a result, a protocol

has now been circulated and data collection for the new HRS will start in January 2014.)

In the light of the rationale and objectives of PP2, the implementation of HRS in the context of this pilot

project would represent a strong added value. In particular, HRS would guarantee:

• correct methodology for evaluating survival differences and adherence to guidelines at population

level at international level;

• implementation of the same methodology also with hospital registry data;

• comparative analysis between the cases of clinical registries and population-based cases with respect

to adherence to guidelines for diagnosis and treatment, frequency and type of pathological events

occurred during follow-up in the long term, with mutual validation of the information contained in

the respective series

• data collection and data organization also for the QoL and health-economy studies.

Stage Coding (see presentation < EPAAC WP8 PP2_Task 4_Van Eycken_Madrid_13092013 >. With the

major objective of increasing the quality of stage-specific treatments, this task aims at the development of

a methodology for consensus coding and categorising of cancer stage at diagnosis, and consistent stage

recording for transmission to registries. The importance of performing these activities in the context of a

cancer outcomes research platform was strongly underlined in the previous discussions on PP2. The main

reasons being that, based on previous studies (Eurocare, HRS, Concord, among others), differences in

cancer outcome appear to be dependent, among other factors, also on diagnostic imprecision and

differences in stage distribution and stage-specific comparisons. As demonstrated by EUROCOURSE

(EUROpe against Cancer: Optimisation of the Use of Registries for Scientific Excellence in research), cancer

registries serve 50-55% of the EU populations, of which only 60% record stage, because of lack of staff

and/or finances and/or access to data. In addition, a concerted effort between EUROCHIP (European

Cancer Health Indicators Project), ENCR (European Network of Cancer Registries) and EUROCOURSE,

demonstrated that only 15% of all the population-based cancer registries (PBCR) in EU had available all the

three most important indicators for understanding inequalities in the cancer burden, care and survival, i.e.

"stage at diagnosis," "cancer treatment delay" and "compliance with cancer guidelines" (Siesling S. et al, Int

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J Cancer. 2013 Jun 15;132(12):2910-7). Future work is needed to optimize the staging systems currently

used in cancer registries, and HRS can be of high value to reach this objective. Based on the most critical

issues to be addressed, as presented in the PP2 parallel session, a roadmap for the next steps to be taken is

under preparation.

Quality of Life. This task focuses on the development of a methodology for improving the collection of data

concerning quality of life and functional status of survivors, through a cross-disciplinary approach and

integration of the different data sources.

Lonneke van de Poll-Franse (IKZ Eindhoven Cancer Registry, The Netherlands), leader of the task,

unfortunately could not attend the workshop. The specific task activities will be defined, taking into

consideration all possible contributors, with particular reference to the OECI working group on survivorship.

Linking health economy to a platform for cancer outcomes research (see presentation < EPAAC WP8

PP2_Task 6_Jonsson_Madrid_13092013 >). Main objectives of the health care systems are: i)

improvements in outcome (population health), including equity aspects; ii) evidence on cost-effectiveness,

i.e. identifying the patients which will benefit most from any given intervention; and iii) well constructed

evidence base, i.e. clear definition of which patients that should be treated. With specific regard to

personalised medicine, definition of a target population is important for assessment of cost-effectiveness.

Thus, to maximize the impact on population health, decisions about access and use of new cancer therapies

by patients, payers and providers should be based on relevant evidence on effectiveness and cost-

effectiveness. This means to address the following critical issues: i) development of evidence on outcome in

clinical practice; ii) development of evidence for health technology assessment (HTA) and decisions about

reimbursement; iii) equity and variations in patients access to treatments, including new treatments,

between and within countries; iv) pricing and affordability. The data needed to be collected as well as the

critical issues to be addressed were illustrated. A methodology for implementing the task activities is

currently in preparation under the lead of Prof. Bengt Jönsson, Professor in Health Economics at the

Stockholm School of Economics and leader of the “Taskforce on evidence based cancer medicine and cost-

effectiveness” of the European Academy of Cancer Sciences.

Feedback from the participants.

A strong interest in PP2 was represented by ENCCA, the European Network for Cancer research in Children

and Adolescents project (www.encca.eu) (see presentation < EPAAC WP8 PP2 -

ENCCA_Cañete_Madrid_13092013 >. ENCCA aims to accelerate clinical and translational research in

paediatric and adolescent oncology and to promote evaluation of and access to innovative therapies. In the

context of ENCCA: i) the WP 11 aims to establish methods to work with cancer registries and linkage to

other forms of routine health care data, in order to conduct prospective research in childhood cancers

where the overall population has a good prognosis; ii) the WP 10 aims to develop risk-adapted therapies in

solid tumors, mainly neuroblastoma. Based on these specific objectives, ENCCA expressed a strong interest

in interacting with PP2 for establishing a cancer registry-wide study of survival from infant neuroblastoma,

as an exemplar of this approach in childhood cancer. The aim is to include as much information as it is

possible to obtain from either HRS or by linking to health records, to document the nature of the treatment

received [surgery, chemotherapy, radiotherapy, MIBG (metaiodobenzyl guanidine)] and the date of

progression or relapse. Clinical treatment decision making is complex in this very rare and heterogeneous

disease entity and there is evidence that overall survival has decreased in the last decade when no standard

treatment guidelines or clinical trials were available in many countries (see document “NBL worse survival

in infants off trial Scientific report2010-NBL charts”). Of equal importance, survivors may suffer long term

adverse health consequences from treatments that may not have been indicated in this cancer that has an

overall very favourable prognosis.

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The importance of the implementation of PP2 was also underlined by Prof. Giorgio Stanta, Chairman of the

OECI (Organisation of European Cancer Institutes) Working Group on Biobanks and Molecular Pathobiology

and coordinator of the IMPACTS group (www.impactsnetwork.eu) which, since 2005, has developed

validation and standardization of molecular methods in fixed and paraffin embedded tissues. These

methods represent a unique tool for investigating, in tissues available in all the cancer centres and

hospitals, the real clinical heterogeneity of cancer and for performing molecular analyses aimed at the

clinical validation of biomarkers in archive tissues by multi-centric retrospective studies. The importance of

applying said methods/approaches for the discovery of new biomarkers on a population basis, by linking

the ensuing results to high-quality clinical data and population-based cancer registries in prospective

studies, was underlined by Ulrik Ringborg and a general agreement was expressed by the participants. It

was generally agreed that the operational link of the above-mentioned activities with those foreseen in PP2

appears of utmost importance for a “holistic” approach to biomarkers discovery and validation leading to

an evidence-based prediction of biomarkers value for clinical cancer outcomes.

In consideration of the outcome of the PP2 parallel session, the envisaged and desirable functional and

operational interactions between the EPAAC WP8 PP2 and other initiatives currently ongoing at the

European level are illustrated in Figure 1.

Figure 1: Possible functional organisation of a European Cancer Outcomes Research Platform.

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Future steps

- A roadmap for the implementation of the above-mentioned activities as well as their detailed

definition will be developed with all the interested actors, involving those indicated in Figure 1 but

also including possible additional ones with whom initial contacts are ongoing or will be established

soon. As mentioned under the preceding section, the definition of such a roadmap is currently

ongoing as for the tasks “Linking Population-based and Clinical Registries”, in close interaction with

the EurocanPlatform WP11, and “High Resolution Studies”, in collaboration with the cancer

registries and clinical centres already involved in these studies.

- Specific advice will be requested to the European Commission concerning options for the

implementation of PP2, in terms of instrument/funding scheme, possibly to be started under the

first Work Programme of Horizon 2020.

- In parallel, the issue of sustainability of a European Cancer Outcomes Research Platform will be

addressed with all interested funding organisations, those partnering in TRANSCAN in the first

place, with the aim of establishing a network willing to commit financially in said initiative.

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EPAAC WP8 Research Workshop,

Key milestones and key issues related to Pilot Project 3

“Building a Knowledge Hub in Cancer Epidemiology and Public Health Research”

EPHECAN HUB proposal.

1. Background

Objectives of Pilot Project 3

The EPAAC WP8 Pilot Project 3 (PP3) “Knowledge Hub in Cancer Epidemiology and Public Health Research”,

hereinafter EPHECAN HUB, intends to be a virtual multicentre and multidisciplinary research centre that

enhances Cancer Epidemiology and Public Health (EPH) Research in Europe. This virtual research centre

could be composed by a network of quality research groups, emergent groups and groups in less favoured

regions of the EU focused on Cancer EPH. EPHECAN HUB should involve not only researchers, but national

funding agencies and other relevant stakeholders in the field.

The Mission:

EPHECAN HUB will increase efficacy and excellence in European Cancer EPH research:

o By fostering collaboration to simplify large population studies, including dimensions such

as different analytical studies examining the risk associated with environmental and

behavioural exposures, studies on early detection of cancer, impact analysis of all policies

on health, and policy scenarios for cancer prevention.

o By raising the amount of European coordinated research projects funded by national

research agencies as a way of contributing to the coordination of Cancer EPH research

agendas at European, national and regional level.

o By mapping strengths and gaps across European, to enable national and European

founders to develop collaborative targeted research in cancer prevention and control.

o By facilitating the innovation processes and the effective knowledge translation from

Cancer EPH studies to Cancer prevention public policies and interventions.

o By enhancing educational efforts in all areas to implement EPH knowledge into

intervention programmes as fast as possible.

o By reducing the fragmentation of European Cancer EPH research through harmonization of

methodologies, development of specific technological platforms and implementation of

common standards.

The PP3 objective in the intermediate term is to test the feasibility of the EPHECAN HUB through the

development of four key tasks identified by the participants:

1. Create a map of cancer prevention and control research and innovation across EU Member States

and regions, drawing on key informants from research agencies, cancer control authorities,

professional groups, NGOs, Ministries of Health and previous project outcomes.

2. Identify leading research initiatives across Europe for shared issues (aetiological, interventional),

review gaps and prepare programme for future work.

3. Review past research for prevention and control, identify successes and failures in uptake and

impact, measures of outcome and change in policy (including ‘do not do’) in association with

national/regional technology advisory bodies and policy organisations.

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4. Hold coordinating meetings between leading research and innovation agencies to develop

targeted research programmes.

For a more detailed description of the project proposal please see Appendix 1.

Moving towards PP3: steps taken and main achievements

Identification and prioritization of areas in cancer research following consultation with the cancer

community: Over 200 experts from the cancer field, including patients, researchers, epidemiologists,

public health experts, biotechnology experts, immunologists, clinicians, nurses and allied professionals,

pathologists and industry representatives, gave feedback through the questionnaire.

Epidemiology and public health cancer research was identified as an important area to target in

coordination efforts. This area contains a wide range of subjects that were mentioned in the questionnaire:

o etiological research with large cohorts

o epidemiological studies

o screening

o research and development of biomarkers

o health impact of environment and lifestyle

o evaluation of interventions

o communication

o inequalities in cancer

o epigenetic and exposome studies (in collaboration with BBMRI)

According to the questionnaire, all these single proposals are in need of coordination at European level and

at that moment cross-border research networks emerged as the best vehicle to achieve this goal. Networks

have the potential to boost research capacity by connecting specialised research groups in cancer

epidemiology and by including less experienced research groups in large European studies. Sharing the

knowledge gained with the population—essentially including them as a node in the network approach—

also helps in getting population support on board and advocacy for evidence-based prevention policies.

EPAAC WP8 Research Forum (Brussels, July 2012): During the panel discussion with founders,

researchers, clinicians, patients, industry, public health experts and policy makers the general agreement

was that prevention and public health research is another highly relevant and important area. For these

reasons the 3rd pilot project should be focus on this subject and Spain (CSISP and ISCIII) compromise to

lead the proposal.

Follow-up workshop (Paris, October 2012): The first ideas were presented at an EPAAC workshop in

Paris (October 2012), where participants expressed their enthusiastic support to the proposal.

Presentation of PP3 at the TRANSCAN meetings (Athens, June 2013): the state of PP3 development,

as of the Valencia meeting, was presented to the funding organisations partnering in the ERA-NET on

Translational Cancer Research TRANSCAN.

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2. Valencia meeting. 3th April 2013, Valencia (Spain)

The PP3 parallel session in the EPAAC WP8 workshop held in Valencia had the main objective of sharing the

first ideas presented in Paris with a selected group of relevant European researchers in epidemiology and

public health. The main outcomes of this meeting are reported in this section.

During the Second Research Forum held in Valencia, a formal kick-off was organised with a group of about

20 European researchers in cancer epidemiology and public health. In-depth discussions brought to light

some key coordination issues and helped to chart a path forward in the implementation of a knowledge

hub in cancer epidemiology and public health research.

During the meeting, the proposal is seen to carry a lot of weight due to its innovative and inclusive nature,

bringing together researchers, funders, patients, the scientific community and industry. It is also

understood to be very timely due to current institutional developments at European level and the potential

opportunities afforded at this time.

DG Research was in the process of putting together plans for Horizon 2020, the successor to FP7 and

therefore close links should be retained in order to input ideas and recommendations at a timely stage.

Public health research was very modestly funded under FP7, but it is anticipated that Horizon 2020 will

support networks of research institutions (which may involve research into public health). Furthermore, the

Joint Research Centre in Ispra is setting up activities in this field, including a network of cancer registries

and a network of screening prevention, and as such should be approached about possible support

mechanisms for an initiative in public health and epidemiology research. DG Sanco is the owner of the

EPAAC project and as such continued collaboration is important.

During the meeting several key issues were discussed, such as:

Why do we need the coordination and what kind of coordination: An understanding and common

agreement is needed on the added value of collaboration in cancer epidemiology and public health

research, in order to convince policymakers and national research funding organisations alike to invest in

coordinated initiatives. With regard to ‘selling’ the idea at European level, it is necessary to describe the

problem at hand, explain how addressing it will respond to societal challenges, and state how added value

can be gained by tackling it at European level and with respect for European values such as equity and

subsidiarity.

Drawing lessons from the Spanish experience and other networking initiatives: Important lessons may be

learnt from the spanish CIBERESP experience for a European level initiative, even if the idea is not to extend

this model to the European level. The EU assigns very little money to epidemiology, and therefore by

collaborating and speaking with a single voice the community has more power to leverage support and

funds for its interests. The conceptual framework for such an initiative needs to be clearly explained, and

added value for Member States illustrated; some countries and regions are already very well organised, e.g.

Nordic Cancer Union, and the value or coordination with other countries and regions may not be

immediately obvious.

Funding: While it is noted that in many countries the vast majority of research funding goes to biomedical

research rather than epidemiological research, it is considered important to promote investigations into

the links between molecular markers and prevention. Regarding funding of a European initiative, it should

be noted that there are differences between Member States regarding sources of funding. For example, in

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north-west Europe cancer societies play a strong role while in south-west Europe they play a lesser role and

government money is more heavily relied on.

Another strategy for attracting funds that was discussed during the meeting was by mobilising the different

epidemiological communities on a national and international level. The involvement of key persons with

wide experience in their fields who emphasise the need for epidemiology funding in Europe is a means of

reaching potential funders.

Links with other projects: A crucial issue was the way in which the hub could link up with large projects in a

highly stable and scientifically productive network such as the European Prospective Investigation into

Cancer and Nutrition (EPIC), Eurocadet or PHIRE, among others.

Moreover, the hub will support the improvement and evolution of better research practices to benefit the

European research community by (a) leading initiatives focused on research quality enhancement; (b)

identifying and developing infrastructures and tools for research to be used in a more efficient way

between Member States; (c) cooperating with other European organisations to address common priorities;

and (d) disseminating new developments in cancer prevention to citizens’ and patients’ organisations.

Drawing on lessons learned and suggestions made, some conclusions were made to implement the

European initiative in epidemiology and public health research:

• It is not possible to build on existing initiatives (JPI on healthy diet and healthy lives, TRANSCAN,

ESFRI, JPI on urban mobility etc) but rather a new initiative/model is required.

• Social innovation is the key issue. It is necessary to explore how innovation can be applied to

coordination.

• Proper funding is required for the new initiative, at least for meetings and potentially a secretariat.

• It may be best to start with an informal network which could grow and develop into something

more official at a later stage.

• The soon to be formed European Association on Cancer Epidemiology (together with the JRC) could

be a platform for hosting/organising meetings.

• A European initiative in epidemiology and public health research could consider including not only

Cancer but also other chronic diseases.

• A ‘knowledge hub’ could serve as a forum for research groups to answer questions that need to be

answered such as: where are the gaps in European research?.

• Ground rules must be defined and common objectives and functions well laid out.

• Policymakers at national and European level should be clearly informed about the need for such an

initiative.

• It is recommended that more focus is placed on “health” than on “disease”, specifically on

prevention. The environment and risk factors are extremely important at young ages. Especially

with longer life expectancy and a growing elderly population, it is very important to also start to

focus on the healthy young population.

• It is essential to create awareness for epidemiology linked to biomarker research. Linking these two

areas would give more opportunities for funding.

• There are many excellent research groups in this field, they together produce the results, and single

researchers need the power and resources in their organization to initiate scientific projects or

structural changes.

• A long application and approval process will reduce the number of good brains in the organization.

Good brains already have their collaborators. A short procedure is required, this should also allow

newcomers in the field to enter. These people might not have many publications, but they do have

good ideas and the drive to move forward.

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• With regard to the areas of EPH cancer research to be included in the proposal, it was suggested

that an ideal scenario would include all areas in a current priority ranking, as priorities change

depending on society and the environment or the economy. The representatives of these areas

should have the capacity to vote on which areas are to be included perhaps using some kind of

proportional system.

3. PP3 developments during and following the EPAAC WP8 Workshop in Madrid

The PP3 parallel session in the EPAAC WP8 workshop held in Madrid had the main objective of

consolidating the PP3 proposal by defining the details, in terms of structure, objectives and activities and

delineating the steps needed for its implementation. These objectives were achieved during the discussion

with selected experts, for a detailed list of participants see Appendix 2. To consult the details of the

presentations see Appendix 3. The main outcomes of the meeting are reported in the following section.

Opening of the session and introduction to the Pilot Project 3 (PP3)

Teresa Corral from Institute of Health Carlos III (ISCIII, Spain) presented the Agenda for the parallel

session.

Rosana Peiró, from Valencia Public Health Research Centre (CSISP-FISABIO, Spain) briefly explained

the how the proposal of PP3 was shaped within the framework of the EPAAC joint action, taking

advantage of the already running model at the Spanish CIBERESP (Biomedical Research

Networking Centre for Epidemiology and Public Health), its objectives, the roadmap for its

progress, project present state, and future steps for its development.

Main objectives of Valencia and Madrid meetings are to:

• Gather support from key researchers and institutions

• Agree on the basic structure of the Knowledge Hub (KH)

A further step needed for the viability of this project is to gather the support of the national

funding agencies.

Participation by Skype: Drawbacks detected during the Eurocan+Plus project for research

coordination on prevention. How can an EPH-KH overcome the barriers? José M Martín-Moreno. University of Valencia, Spain

The experts participating in the work package devoted to cancer epidemiology and prevention of

The Eurocan+Plus project concluded that research in these areas is fragmented, and there is a

strong need for more coordination (the final report is available through the Eurocan+ website).

Barriers, including those rooted in culture, institutions and in communication, were identified and

analysed, and solutions were proposed in six areas: Education and mobility; Data and information;

Legal issues; Funding; Coordination barriers; and Cultural barriers.

José María Martín-Moreno explained that since the end of the project in 2007 the scenario has

changed, but some of the findings are still valid, and their integration in the KH proposal would

increase its interest. KH is an initiative that could promote and foster research in cancer

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epidemiology, but both Member States and researchers must make an explicit commitment to this

initiative in order for it to flourish.

As a result of the discussion of the report it was agreed that it would be necessary to update the

report, and publish it in a peer-review journal. This report would also become then part of the PP3

report and its funding recommendations should be forwarded as recommendations for inclusion

into Horizon 2020. José María Martín-Moreno and Markus Pasterk agreed on drafting an update

for circulation.

Presentation: Building a Knowledge Hub in Cancer Epidemiology and Public Health Research.

Rosana Peiró. Valencia Public Health Research Centre (CSISP-FISABIO)

Rosana Peiró presented the basic features of the KH, motivation to create it, general research

objectives and organisational objectives, and how this proposal can contribute to coordinate and

strengthen Epidemiology and Public Health (EPH) research at European level. In this line, the KH

should promote that national/local agencies fund the research groups and the KH only fund the

coordination activities.

The key research areas included in the proposal were presented

• Three main areas

Area 1: Environmental Occupational and Population Health Research

Area 2. Impact of public policies in cancer and health economics

Area 3. Early detection of Cancer

• Three transversal areas

Area 4. Inequalities and social determinants

Area 5. Molecular epidemiology and bio-banking

Area 6. Education and mobility

As well as the common activities to develop within each area:

- To identify potentially interested and relevant groups

- Reach agreement on work proposals

- To contribute to a common research agenda in Europe.

- To identify key databases useful for research proposals.

- To identify validated questionnaires

Beatriz Pérez pointed out the need of a short-term reward. In relation with this, it was highlighted

that at Valencia EPAAC meeting it was suggested that local funding agencies may consider the

participation of the researchers in this KH as a merit to obtain local funds.

Presentation: KH structure.

Ana Levin. Valencia Public Health Research Centre (CSISP-FISABIO)

The KH managing structure will be composed by a Managment Board (MB) constituted by

members of funding agencies (national and European level) in charge of decision-making, assisted

by two advisory bodies: Scientific Advisory Board (recognised specialists in the EPH area) and

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Stakeholder Advisory Board (Research Institutions, European Commission, opinion leaders, patient

associations, industry). The MB will develop the criteria for selection of excellent/emerging

groups. The secretariat will provide technical support to the MB, and will be in charge of executive

tasks such as KH Communication Platform, knowledge transfer, Intellectual Property Rights (IPR)

advice, and reporting.

The Communication Platform main features will be: website, compiling relevant websites and

databases in cancer EPH, communication and dissemination plan (considering social media), and

exploitation plan (IPR consultancy, technological catalogue, patent application management) to

assure knowledge transfer.

Minimal human resources needed will be one project manager and one/two technical officers.

Pros and Cons of Knowledge Hub proposal

Presentation: Experiences in a network of cancer research centres for translational research:

EurocanPlatform.

Cornelia Ulrich. National Center for Tumor Diseases. Heidelberg. Germany

Cornelia Ulrich briefly described the Division on Prevention Oncology that she leads within the

National Center for Tumor Diseases, NCT Heidelberg. Within this division, the group Cancer

Prognosis, Survivorship & Pharmacogenetics (led by Dr. Schrotz-King/

Dr. Staffa) is conducting two major studies related to cancer prevention: the Colocare project and

the Eurocan Platform.

The Eurocan Platform WP11 aims to create a platform for joint translational cancer research

among European clinical cancer registries. Joining forces inside the project has positively

influenced the research results as it has been shown through different pilot projects including

initial cross-national study protocols. These pilot studies show that relevant studies are possible

within the Platform using already existing data and their initial findings demonstrate utility and

clinical relevance of mutual studies in clinical epidemiology.

Public health should involve molecular techniques and new diagnostic and screening tests at

population level and that this should be taken into account by EPAAC project. She would like to

participate in the EPAAC initiative if it moves forward, but there is a need for assessment of

resources needs for comprehensive activities.

Cornelia Ulrich and collaborators in Germany have developed a new Molecular Public Health vision

(to employ beyond state-of-the-art molecular tools for prolonging life, preventing disease and

promoting health through organized community efforts) that aims to result in interventions at

public health level.

It was highlighted the unknown character of some of the relevant data presented and the need to

communicate some of those research findings to the public.

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Prevention research projects should also address how policy-makers uptake the results and

transform them into useful health policies for society. An Eranet such as TRANSCAN would be an

idea of the kind of projects that can be coordinated through the KH.

The KH should have resources that go beyond general funding of networks, and should include

also funds for activities such as student funding or staff funding, ideally with student exchange.

Additionally, it would serve to link and joint forces of other networks and projects in the area.

Rosana Peiró underlined that the implementation of prevention policies is also a mechanism for

economic development and there is a wide field for intervention. Molecular epidemiology area is

very important and the Molecular Public Health vision seems very relevant.

It was raised the question on the relevance of some of the risk factors for many health research

areas but it was agreed that the molecular area has to be specific for cancer and the focus of the

KH should be in cancer, although open enough to collaborate with other diseases or areas.

Discussion of the KH proposal and implementation

Markus Pasterk mentioned that the idea is feasible. Regarding the secretariat, it is proposed that

national or local funding agencies may provide funds to support it. One or several countries may

propose it and the MB should choose the best option.

It was pointed out that decisions should be very transparent and conflict of interest between

Scientific Advisory Board (SAB) members and research areas beneficiaries should be avoided. The

SHAB (Stakeholder Advisory Board) should include all type of stakeholders, such as patients, ethics

committees, European Commission, industry, etc. In order to have research results generated by

this KH implemented into health policies or new interventions, it was proposed that health

authorities (ministries, social security services or any structure who implements or prepares or

develops the policies) should be involved in the KH decisions (SHAB or MB) so the results can be

transferred to society.

Beatriz Pérez highlighted that the KH should serve to influence public health policies and Rosana

Peiró that its focus should be in the determinants instead of in the disease.

Potential Scientific areas of the Knowledge Hub

Presentation: Prevention policies: the impact of the epidemiology and public health cancer

research. Lessons learnt from Eurocadet project.

Jan Willem Coebergh. Erasmus University. The Netherlands.

Eurocadet delivered a piece of software that estimates the impact on incidence of different cancer

prevention policies (Prevent model). As conclusion of the Eurocadet project, it was found that

prevention could be large (25-40%) and feasible, but that many forces need to be mobilized

(awareness) and effective interventions remain rare and are implemented after many years of

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having the data (smoking, alcohol consumption, physical exercise). This model could be used

through the KH as part of common armentarium: needed repository of scenarios. Guidance would

be needed from Erasmus MC dept of Public Health, as well as compilation of recent data on trends

in incidence from the EUREG database based at IARC and exposures from cohort studies / Eurostat

data.

General discussion

Regarding the scientific areas of the KH, bio-banking contributes to every other group and not only

to areas 1 and 3. Research on bio-banks always raises ethical and legal issues with data protection;

these are important in bio-banking and should be taken into account. Any research on bio-banking

should be done in coordination with the BBMRI-ERIC research infrastructure.

From the Eurocan+Plus project experiences it is known that there should be mobility not only

among students, but also among trained clinical oncologists and other scientific postdocs in all

interdisciplinary fields of cancer research within Europe. There are not such tools to help that

mobility or virtual mobility; so this might be an issue to address at the KH.

Within FP7, the IMI EMTRAIN training project in life sciences (and its course catalogue “on-

course”) might be a good tool to identify educational courses in Public Health around Europe.

What is missing is an agreed curriculum for Cancer Public Health. We should find some universities

that want to join to develop such a curriculum and are interested in implementation.

Promotion of awareness might be an important issue to work through the communication

platform of the KH.

Public authorities are the ones in charge to turn the evidence in policies, so it was agreed that

public health authorities and policy-makers should be part of the management structure of the

KH, probably within the Stakeholder advisory board (SHAB).

It was mentioned that since the KH is a platform to enhance collaboration the research areas

description should not be very detailed and no areas should be excluded.

To summarize:

- The general proposed structure for the KH was approved

- Scientist interested in working at any of the proposed areas are asked to contact proposal

leaders

- It is a pending issue to gather the support of funding agencies

- The research areas proposed are correct but there should be some changes: name of the

Environmental, Occupational and Population Cancer Research should change to Environmental

and Behavioural cancer research, and areas should be more interconnected.

- Communication with society, advocacy groups and patients has to be active and is a very

important part of the KH- Communication Platform.

- There is a need to work on the transfer of research results into public health policies

- Educational efforts in all areas in order to implement knowledge into interventions are

needed.

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4. Future steps

- To develop an implementation roadmap following the activities described on section 1

with relevant stakeholders and scientists.

- Request for implementation advice to different EC bodies. DG Research and DG Sanco

have been contacted to discuss the issue of implementation and sustainability and first

contact meetings are being set. We would like to explore the possibility of applying for

funding for a feasibility study under the first Work Programme of Horizon 2020.

- At the same time, we are seeking for support of the scientific community as well as

international funding agencies, previously funded project leaders or interested

organizations to build the initial network of participants. The already received Letters of

Support are listed on Appendix 4.