Cancer Trials Ireland: 2 Cancer Research Team Development Day · 2017-07-04 · Attendee’s &...

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Cancer Trials Ireland:2nd Cancer Research Team Development Day

Hilton Hotel,

Kilmainham,

Dublin 8,

January 26th 2017

This meeting has been kindly co – sponsored by AbbVie : Astellas : Bayer : BMS : Genomic Health : Janssen-Cilag : MSD : Novartis : Roche

Sponsorship

Welcome & Recap Shane Ring,Business Development Manager, Cancer Trials Ireland

Rationale for the introduction of these meetings?

➢Conversations with you and colleagues

➢No real forum to meet and discuss issues

➢The DSSG meetings – Incredibly busy and little time to network

➢“This has been talked about for year”

www.cancertrials.ie

The Inaugural Meeting:

Grand Canal Hotel,Dublin 4September 22nd 2016

Attendee’s & Format in numbers

• 36 Cancer Research Team Members

• Team Leaders / Data Managers / GCO / Research Radiation Therapists / Research Nurses / Oncology Pharmacists

• 10 from Industry – Lunch : CRO / MSL and 1 Commercial

• 2 Sessions of Appreciative Inquiry

• 1 Workshop - Future Structure of Development Days

• St.James / St.Vincents / Crumlin / St.Lukes / Beacon / GUH / CUH / Tullamore / Limerick / Beaumont (Radiation) / AMNCH / GCO

www.cancertrials.ie

Themes identified for further development

PatientsKeep patients at the center of decision making; patient base not PI based

Trials standardization

Increase access to trials for more patients

PeopleStaff – role definition and clarity

Role security for staff

Career Path development and support

Teams – multidisciplinary dimension of teams – clinical, non-clinical and administrative – recognizing the contribution of all

Education and development initiatives – for example Masterclasses, Project Management Skills

New ways to improve motivation and morale

Engaging proactively with other Stakeholders – HSE, NCCP and Hospital Management – identification of key stakeholders and increase their

awareness of Cancer Trials Ireland

www.cancertrials.ie

Themes identified for future meetings

ProcessesNetworking processes – across the Cancer Trials Community – sharing, problem solving, risk mitigation etc

Communication processes – using systems such as IT to enable and empower us

Improve meeting processes so that they are solution focused

Closing the feedback loop – this helps with motivation

Monitoring processes – increase understanding of requirement for remote and on site monitoring

PlanningInvolvement with Strategic, Business and Financial Planning

Understanding of financial components of the business – costs and revenue and how cost savings can be utilized

In strategic planning clarify role of Cancer Trials Ireland as a community and also increase access to trials for more patients

Planning and preparation around Phase 1B trials is a concern and is on the horizon for many of the Cancer Research Centres

ProfileEnhancing awareness of benefits to patients of trial participation

Increasing knowledge of part research plays in health and why it matters

Public and key stakeholder awareness of Cancer Trials Ireland

www.cancertrials.ie

Next steps

Review the info captured from the Appreciative Inquiry sessions

Select a topic - Phase 1B Study Set-Up

Processes People Patients Planning Profile

Main Focus for Next Meeting

Workshop:What should be the structure of future CRTDD’s?

Refresher Training

Team Meetings

Share Best

Practices

Speakers

Structure?

Cancer Research Team Development Day

➢This is your forum – For you – Run by you – facilitated by Cancer Trials Ireland

➢Its not my meeting – I didn't decide the agenda!!

➢That’s why we are here, today - Communication / Share

➢Everyone has the opportunity to speak and to be heard

Agenda

Kathleen intro slide

Workshop Time

“What do I need to know to set up Phase 1B Studies at my Research Centre……what areas most concern me?”

Group Breakout Session 30 minutes

▪ Q1: What are the opportunities for your site in running Phase I trials ?

▪ Q2: What are the challenges for your site in running Phase I trials?

▪ Q3: What do you need to run phase I trials successfully?

▪ Q4: What can Cancer Trials Ireland do to drive phase I success?

Group Workshop: Phase Ib Study Set Up

Speaker Session: 60 minutes

• Phase 1B Study set up process

Amanda Bray, BCNI/UHG

• Phase 1B - The research nurse’s experience

Jess Walsh, BCNI/UHG

• Key SOPs to consider when implementing Phase 1B

Keith Egan, Beaumont Hospital

Phase Ib Study Set Up

Panel Discussion & Next Steps?

30 Minutes

Time to grab a cuppa?

Amanda Bray slides

Jess Walsh slides

Communicating to increase the number of patients interested in and willing to take part in cancer trials.

Before interest comes awareness …..

Launch in May 2017

To increase the number of patients interested in and willing to take part in cancer trials.

Before interest comes awareness …..

Patients, their families, friends, etc.

Cancer Trials Community

International Clinical Trials Day 2016

Galway

Limerick

Crumlin

Beaumont

St Lukes

Beacon Tallaght

St James’

Twitter followers up 40% to 1025

www.cancertrials.ie

Your DoctorCancer Nurseline

Freephone 1800 200 700

JustAsk!

Just Ask 2017A communications plan to increase the number of patients interested in and willing to take part in cancer trials during 2017 and 2018.

CRQ Survey Results

Prompting the question and providing the answers

People with cancer, people just diagnosed with cancer, families and friends of people with cancer.

LocalPosters in research units, hospitals, at Daffodil Centres, GP surgeries, support groups, community organisations, direct contact with patients.Publicity, press stories and information events at each hospitalNational Press stories, Radio, online and social media advertising

LocalResearch Units and Daffodil Centres Publicity and information events at each hospital, Patient Packs,Consultants, GPs, support groups, community organisationsNationalWebsite & Cancer Nurseline, Patient Packs in GP surgeries, & support agencies . Media stories

Target for media outreach

Advertising 45+ split 50/50 male/female

Local has greatest impact

Talk to the people beside youPress/Radio

Support groups in the hospital / outside the hospital

Irish Cancer Society

Hospital group managers

Hospital managers

GPs / Public Health Nurses

Communications office

Patients/doctors/nurses in the hospital

Doctors / nurses in Oncology unit

Patients with Cancer

Patients on trials

Ideas for local activities

1. Posters/brochures – we will provide2. Information events, lectures, evening event, local personality

visit3. Pull ups – stands4. Artwork will be available on web site5. Presentation to support organisations, retirement groups, ICA,

Macra, rotary, chamber, Mens Sheds, etc6. Hospital Group website7. Irish Cancer Society Local rep for lectures on well being and

coping8. Contact with GPs – mailer invite9. Other departments – all have families10. Posters in research units, hospitals, at Daffodil Centres, GP

surgeries, direct contact.11. Publicity and Information events at each hospital12. Press / Radio

Press/radio – what to do

1. Patients willing to tell their story – has greatest impact2. Set up 2-3 weeks in advance 3. Contacts from local communications offices4. Mine your contacts first5. Ask journalist to visit and meet patient and team, follow a

patient during a visit/interview separately about what it’s like.6. Have local personality available7. Offer to organise photographer8. Organise photographs, caption and send to papers.9. Have the facts on a fact sheet

• List of trials underway• How may patients are participating• Types of cancer being treated

10. How people can find out more11. Contact names and numbers of unit12. Name and contact of consultants willing to be available

Thank you

Lunch Time!!

Please be back for 2:30pm sharp!!

Welcome Back!!

Naomi Fitzgibbon Slides

Clinical Indemnity Scheme

Research Team Development Day

26-Jan-2017

CONFIDENTIAL: NOT FOR DISTRIBUTION OR COPYING WITHOUT PERMISSION OF CANCER TRIALS IRELAND

• State-provided indemnity for claims from patients whose treatment was part of a clinical trial or other approved research project.

• In trials sponsored by organisations such as pharmaceutical companies, State indemnity extends to treatment only and does not cover product liability or claims arising from trial design or protocol. Indemnity against such claims remains the responsibility of the body conducting the trial or research product and, therefore, an appropriate indemnity should be secured from the external sponsor(s).

• Cover under the scheme extends to claims arising from trial design or protocol including investigator-led trials Applies to Cancer Trials Ireland-sponsored studies

48CONFIDENTIAL: NOT FOR DISTRIBUTION OR COPYING WITHOUT PERMISSION OF CANCER TRIALS IRELAND

• Applies to Public Hospitals

• Does not apply to Private Hospitals (as not covered in the relevant Statutory Instrument)

CIS and Pharma-sponsored studies

• AON has met with Pharm (IPHA) to discuss changes to the standard documentation for indemnity.

• This is bringing about changes to Trial Agreements agreed by AON and Pharma:

– Reference to the Clinical Trial Indemnity Form (CTIF) therefore removing reciprocal indemnity clauses from the Agreements in alignment with the CIS.

CIS and Cancer Trials Ireland-sponsored studies

• We replaced the Site Master Agreement with the Investigator Master Agreement in July 2016 on foot of discussions with AON

– Reference to reciprocal indemnity clauses removed on the basis that Cancer Trials Ireland is a not for profit and does not have the financial worth making the use of an indemnity valid.

Application Process for CIS Cover

• AON meeting with Cancer Trials Ireland on 11-Nov-16

– A circular is expected to be released to hospital sites in the near future to outline the process as some hospital sites have their own process and therefore duplication of the application for the same trial has been observed.

– Confirmation of process awaited from AON.

• AON will no longer need to receive the ethics approvals.

• The CIS cover confirmation from AON will include a statement that it is subject to EC approval. (Therefore still need to have EC approval in place for the relevant sites(s) to ensure covered under CIS.)

• Hence AON will be involved much earlier in the process as we will not have to wait for EC approval before seeking cover for a clinical trial.

• Mandatory:

– Confirmation of sponsor insurance for €6.5m in the annual aggregate of cover per clinical trial.

– List of participating sites (investigators not to be listed).

• Additionally for non-Cancer Trials Ireland-sponsored studies:

– Clinical Trial Indemnity Form (CTIF)

• For information purposes:

– Patient Information Leaflet (PIL) (provides background information on the trial however will not be reviewed or assessed by AON).

Private Hospitals

• AON is insurance broker for most of the hospitals in which Cancer Trials Ireland conducts clinical trials and may conduct trials in the future (except UPMC Whitfield Cancer Centre, Waterford).

• Allianz is the predominant insurance provider in this sector (~90% of the private hospitals)

• The insurance generally provides some level of clinical trial cover and Cancer Trials Ireland to check with each hospital if this cover is included.

Private Hospitals

• Bon Secours Hospital, Cork

• Mater Private Hospital, Dublin

• Beacon Hospital, Dublin

• St Vincent’s Private Hospital, Dublin

• The Galway Clinic (no trials yet)

• Hermitage Clinic, Dublin (no trials yet)

• Bon Secours Hospital, Cork:

• Agreement in place that the CTIF is not required for studies sponsored by Cancer Trials Ireland.

Private Hospitals

• Cancer Trials Ireland to engage with the Private Hospitals Association (PHA) to seek agreement to waive the need for an indemnity to be provided on the basis that Cancer Trials Ireland is a not for profit and does not have the financial worth making the use of an indemnity valid.

• Aim to reach an overarching agreement on indemnity cover and that clinical trials would be covered via the hospitals’ insurance.

Private Hospitals

• Documentation collected for private hospitals:

• Principal Investigators: the consultants generally have medical liability insurance with MPS, MDU or Lloyds.

• We have not collected the following in the past therefore we may need to verify that clinical trials are covered in the hospitals’ policies.

• NCHDs (sub-investigators) generally have cover with MPS or others.

• Other staff generally are covered via the hospital insurance (e.g. Allianz policy).

Claims

• CIS does not provide indemnity for Cancer Trials Ireland but for the trial host, i.e. the hospital site, Principal Investigator and other staff.

• Indemnity is waived for trials sponsored by Cancer Trials Ireland and picked up by the CIS with regard to the trial design Notification procedure to AON under the terms of our own clinical trials insurance policy.

Claims

• For externally sponsored studies, generally the Clinical Trial Agreement (CTA) is reasonably specific in terms of the reporting procedure.

• In the event of a potential claim the CIS is to be notified through the host institution as significant infrastructure for this exists within the hospitals, i.e. hospitals themselves should report the event to the CIS and all sites have access to a web-based system for this purpose.

• AON then deals with the hospital in the event of a claim.

• If the contractual agreement is not adhered to this can result in losses to the hospital/ state.

Resources

State Claims Agency: http://stateclaims.ie/about-our-work/clinical-indemnity-scheme/

Resources

http://stateclaims.ie/resources/

ICH GCP Training at Cancer Trials Ireland in 2017

ICH GCP Training Day 15-Mar-2017

• One day introductory course suitable for:

• new investigational site staff

• Cancer Trials Ireland staff

• open to existing staff with knowledge and experience if they wish to attend full day training as a refresher.

• Open to Cancer Trials Ireland members/ site staff only

• First offering: Wednesday 15-Mar-2017 (further dates in 2017 to be announced)

ICH GCP Training Day 15-Mar-2017

• Course pre-reading

• Interactive workshops

• Scenario-based knowledge assessment.

• Includes the new update to ICH GCP (E6(R2)): effective 14-Jun-2017

• Compliant with Transcelerate minimum criteria for the mutual acceptance of our training by other sponsors

• Register by email (Sandra.Boldrin@cancertrials.ie) as soon as possible indicating name, position and level of experience in clinical trials for the staff member(s).

ICH GCP Training

• ICH GCP addendum (E6(R2)): effective 14-Jun-2017 (EU) being incorporated into:

• GCP refresher course slides (as presented at the DSSG meeting days for investigational site staff)

– 10-Feb-17

– 23-Jun-17

– 20-Oct-17

• Online training course offered via ICON’s Firecrest system.

Feedback Sheets

Wrap up – What should this forum deliver for you

➢ Engage openly and look for mutually-beneficial ways to work

➢ Invest your time and energy not in what is, but what can be

➢ Embrace critique….the good and not so good

➢ Opportunity to share what you know with the wider team

➢ As a team we have more influence and power than as individuals

➢ It’s a commitment to continually better the way we do our jobs

Thank you & Safe journey home!!

Next Development DayThursday 1st June 2017

This meeting has been kindly co – sponsored by AbbVie : Astellas : Bayer : BMS : Genomic Health : Janssen-Cilag : MSD : Novartis : Roche

Cancer Trials Ireland: 2 Cancer Research Team Development Day · 2017-07-04 · Attendee’s &...

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