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23rd June 2017 10.45 – 14.40
Chair - Dan Clutterbuck (Allergan) Minutes - Janina Jezierski (Sanofi)
cCOG Meeting
CCOG
Agenda Time Item Topic details Owner
10:45 Coffee available 11:00 Welcome &
Introduction Agenda Introductions Chair for next meetings (BMS/Biogen?) Confirm minute taker for next meeting (Roche/QED?)
Dan Clutterbuck
11.15 HRA Update mCTA Update Planned changes to website General Questions
Alastair Nicholson / Janet Messer
11.50 NRS Update NRS Website / UK Feasibility Pilot / mCTA (Sent by Steven Burke)
11:55 NIHR Update Commercial Feasibility Recent Service Improvements Study Support Service Commercial Service Offerings & Links with the Devolved Administrators
Lorraine Fincham
12:00 Rebranding Very brief update Reminder for changes to representatives
Sarah Durston
12.05 Other member groups update
• R&D forum• Road Map• CREN• ICR• Costing Group
Member group representatives
12.20 Lunch Break 13.00 cCOG 2017 Objectives Assign and break out into the four groups. Review and progress
objectives for the coming year Coffee available
All
13.45 2017 objectives update Leads of each of the objectives sub-groups to provide update on the objective
Objective leads
14.00 NHS Fax Removal Removal of Fax machines & analogue phone lines – industry experience/position
All
14.10 Any other business General Discussion
14:40 Meeting close
CCOG
Welcome and Introduction
• 2017 Meetings
* Ashlee is new so may look to swap.
Confirm/discuss next Chair/Minute takers.
Reminder: cCOG shall not engage in any Anti-Competitive behaviours
Meeting Date Chair Minutes Thursday 2 February Bayer QuintilesIMS Friday 23 June Allergan Sanofi Friday 15 September BMS (Ashlee Lucas*) Roche / QED /
Chiltern – TBC? Thursday 9 November
Biogen (Sarah Deeley*)
Roche / QED / Chiltern – TBC?
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Welcome and Introduction
• Guests/Speakers – 23rd June 2017
Alastair Nicholson Janet Messer Lorraine Fincham Lydia Vitolo Belen Granell Villen
Policy Development Lead – HRA Assessment and Approval Director of Research Systems, Standards & HRA Approval Programme Commercial Research Initiative Manager, NIHR Senior Industry Manager, Health and Care Research Wales Clinical Research and Regulatory Policy Officer, ABPI
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Welcome and Introduction Company Main Representative Attending
23 Jun 2017
Main Rep Email (Stand-in in brackets where applicable)
AbbVie Liz Sheasby Yes [email protected] Allergan Dan Clutterbuck Yes [email protected]
Amgen Sarah Durston Yes [email protected] Astellas Darleen Ewen Yes [email protected] Astra Zeneca
Sophie Gillmore No [email protected]
Bayer Gillian Waite Stand-in [email protected] ([email protected])
Biogen Sarah Deeley No [email protected] BMS Katie Ellegard (while Sophie
Peacock on Mat leave) Yes x2 [email protected] / [email protected]
Boehringer-Ingelheim
Graham Oakley / Natasha Lee Stand-in [email protected] or [email protected] ([email protected])
Chiltern Emma Massie Yes [email protected] Covance Hannah Wilding Yes [email protected] Gilead Charlotte Vigor No [email protected] GSK Martin Gill Yes [email protected]
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Welcome and Introduction Company Main Representative Attending 23 Jun 2017 Main Rep Email (Stand-in in brackets where applicable)
ICON Marianna Pissides No [email protected] Janssen Julia Baird No [email protected]
Lilly Scarano Roberto Yes [email protected] MSD Emma Whelan Stand-in [email protected] ([email protected]) Novartis Jane Lindsay Stand-in [email protected] ([email protected])
Novo Nordisk
Pauline Szczerbicki Stand-in [email protected] ([email protected])
Orion Steve Hietschold No valid contact details [email protected] Pfizer Nyree Forton Yes [email protected]
PPD Hugh Devine Yes [email protected]
PRA Thijs Schreuder Yes [email protected] Quintiles Donna Kapaya Yes [email protected] Roche Catherine Roynette Yes [email protected] Sanofi Janina Jezierski Yes [email protected] Servier Helen Whitrow Unknown [email protected]
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HRA Update
Alastair Nicholson Policy Development Lead – HRA Assessment and Approval Janet Messer Director of Research Systems, Standards & HRA Approval Programme
• mCTA Update • HRA Website Redevelopment • General Questions
HRA Website redevelopment
Our website is out of date • The current HRA website has grown
organically as we have taken on new services and responsibilities.
• It is dense and complex to navigate, holding around 400 pages and over 1,000 documents.
• The user journeys are unclear and result in a large number of contacts by users via phone and email – not a good use of time.
• We are developing a new HRA website that meets the needs of our users, is future-proof and responsive to emerging technologies and trends, and allows us to keep pace with the fast-paced nature of research.
We’ve asked our users what they want Our user research includes • User testing with researchers • Website survey with external users • Interviews and surveys with internal staff • Analytics reporting
Common frustrations • Can’t find information about the HRA Approval
process quickly • Can’t find the contact details of my REC • Can’t find information on how to submit an
amendment to my research project • Don’t have a clear idea of the purpose of HRA
“Content is
too turgid”
"There are no clear links, too much text, the search function doesn't work well enough and it is generally very difficult to use”
“Tortuous circular paths”
“ I find that I have to click through lots of different places to find what I am looking for”
“Links lead to further links and some of the information refers to NHS permission so it's not clear if it's up to date”
REC members Experienced
researchers
Facilitator (e.g. NHS
R&D Manager)
Hosts (of research)
Sponsors (accountable)
Interested Party
Internal Staff
Researchers “Applicants”
Industry sponsors
Health professional
Students (40% of
applicants, needs
most help)
Academic sponsors
NHS sponsors
Funders
3rd sector
Health sites Social
care sites
Lay member
We have identified what our key audience groups are:
Public
We have developed ‘personas’ which allows us to keep our users top of mind when planning and writing the new site
As a research sponsor I want to learn about getting participant consent so that I can advise researchers I support how to manage their studies.
User journey: Improving research > Best practice > Participant consent
Organisational goals • Provide advice on research good practice • Provide advice on policies and standards
Example user story - Sponsor
We have created a series of ‘user journeys’ for the site
Our user testing has led us to create three main sections to the site:
• How to go about getting HRA Approval; managing your project including amendments and ending your project. Detailed application guidance will be linked through to IRAS
Approvals and amendments
• Research planning; best practice; policies, guidance and legislation; public and patient involvement
Improving research
• Corporate information; HRA committees and services; REC members area; news and updates, governance
About us
We’ve identified some key themes for the new site • A clearer, more consistent tone of voice with more
direct language and less waffle
• More ‘layering’ of information rather than presenting all at once
• User-focused design and content with regular testing throughout development
• Clarity about what sits on the HRA website and what guidance is available on the Integrated Research Application System (IRAS)
• IRAS is system used to seek permissions & approvals for health & social care research in UK.
• Existing guidance in IRAS Help section is being re-organised and enhanced to provide more information about how to apply for various approvals available in the system and how to maintain those approvals.
• IRAS Help section is always accessible – you don’t need a log in.
• Reciprocal links and signposting will be in place between HRA and IRAS sites.
We have designed the site so that users can more effectively digest the sometimes complex subject matter whilst giving the added benefit of a more spacious and modern feel. Clear signposting and more engaging content through a journalistic design approach, which will help to create a sense of activity and progression around the organisation.
Optimised
for mobile
Timelines and launch
NOW: content migration and creation, restricted-access Beta site that we can test with users and check user journeys
Early July: Public Beta site that will run alongside the existing site so that users can get used to the site before it is launched
Late July: Launch of new HRA website
Timelines and launch
NOW: content migration and creation, restricted-access Beta site that we can test with users and check user journeys
Early July: Public Beta site that will run alongside the existing site so that users can get used to the site before it is launched
Late July: Launch of new HRA website
Please help us by getting involved in testing the new site and give us your feedback
Email [email protected]
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HRA Update
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HRA Update
Member Question: “I would like to clarify with the HRA the process for implementation of updated Investigator Brochures at site, after they have been submitted and approved as Substantial amendments.”
CCOG
NRS Update • NRS Website
o There have been some upgrades to the industry section on the NRS website and includes a study pathway guideline to help drive start-up and answer FAQ http://www.nhsresearchscotland.org.uk/working-with-us The information available in this section will be enhanced by the cCOG objective
group looking at start-up flows across the UK o Information and resources covering activity in NRS can be sourced on the website
http://www.nhsresearchscotland.org.uk/about/resources
• mCTA o NRS are working actively with our colleagues in the HRA and ABPI to update the mCTA.
• UK Feasibility pilot o Lorraine Fincham will provide an update on behalf of the UK-wide group. o We have agreed to participate in a uk-wide site-ID pilot aimed at growing the number of
research sites across the UK and providing customers with a central point. The pilot will be limited to companies that have agreed to participate and the number of companies will continue to grow as we learn from the data produced from the pilot.
Provided by Steven Burke ([email protected])
The NIHR CRN service offerings to Industry - Commercial Feasibility update Lorraine Fincham, Commercial Research Initiatives Manager
Clinical Research Network Coordinating Centre
cCOG meeting 23rd June 2017
Clinical Research Network
Recent service improvements
CRN is continually improving our support of the life sciences industry as defined in our strategy • A recent example is the review of Site Intelligence and Early Feedback
content with NIHR Roadmap group members • The aim is to improve quality of services by focusing on key information
required by companies • Early feedback questions reduced and streamlined into key areas • Site intelligence revised to focus on supplementary insight from the CRN in
relation to study delivery at company-selected sites • Timelines - aiming for revised Site Intelligence form and Early Feedback
form to be in use by end of July
Clinical Research Network
Study Support Service
http://www.nihr.ac.uk/life-sciences-industry/running-your-study-in-the-nhs/study-support-service-summary/
Clinical Research Network
Commercial Service Offerings & Links with the Devolved Administrations
• Proposed interim solution to ensure that Devolved Administrations (Northern Ireland, Scotland & Wales) are included in site identification service requests:
• Companies will be advised when entering the study into CPMS to that part
B will be shared with the the Devolved Administrations • Companies should contact support my study helpline immediately after
submission and quote study number if they do not want information shared • Planned starting date 31th July 2017 with a sample of companies NIHR CRN Industry Information Centre Email: [email protected] Phone: 00 44 113 34 34 555
Clinical Research Network
Commercial Service Offerings & Links with the Devolved Administrations
• The Feasibility Team will include the Devolved Administration (Northern Ireland, Scotland & Wales) in the same email request that is sent to the Local Clinical Research Networks
• A single point of contact email address for each devolved
Association will be used, and Part B of the CPMS submission will be downloaded and attached to the email
• The Devolved Administration will circulate the form to their
PI/Sites • The forms will be returned directly to the company/CRO
contact
Clinical Research Network
Thank you NIHR CRN CC Industry Team:
[email protected] Lorraine Fincham [email protected]
CCOG
cCOG Rebranding Update
Website Reminder • CCOG website kindly hosted by ‘Health and Care Research Wales’ and ‘NHS Research
Scotland’: • https://www.healthandcareresearch.gov.wales/commercial-clinical-operations-group/ • http://www.nhsresearchscotland.org.uk/working-with-us/industry/why-scotland
CCOG
cCOG – Membership List
• Member Representatives: • Due to rotating chairs, it is a constant struggle to keep the list of
member representatives up to date. • Sarah Durston has agreed to maintain a list of member’s email
addresses. • Any changes in representatives should be communicated directly to
Sarah at [email protected]. • Any temporary changes (i.e. cover for a single meeting) should be
communicated to the applicable Chair. • Finally, please respond quickly to any emails if you are no longer
the representative, and if you are the Chair, please ensure you only use the most up to date list (which you can get from Sarah).
CCOG
cCOG Member Groups • R&D forum
• Road Map
• CREN
• ICR – remove going forwards?
• Costing Group • New costing template released on 20th April
• Invoicing elements removed
• Template has been rebuilt without any macro / coding
• R&D, CI, Pharmacy and archiving fees increased to reflect actual expenditure
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LUNCH
Restart at 13.00
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cCOG – Objectives cCOG members will agree annual objectives that will be supported each
year by a sub-team of members. Members will take steps to deliver on the objectives and report back to
members during cCOG Meetings. At the last meeting of the year a final review/close out of the objectives will be conducted.
New objectives, which may include those extended from the previous year, will be agreed at the first annual meeting.
To help keep focused, the following slide has the cCOG Purpose and Vision. Objectives must be aligned with these and achievable.
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cCOG Charter Purpose:
cCOG was formed: To represent commercial sponsors and industry partners of clinical trials and to ensure the UK remains competitive and a key player in the global clinical trials environment.
We exist to: Develop common understanding and support for streamlining clinical trial conduct in UK, promote knowledge sharing and identify best practices.
We work to: Support UK initiatives through delivering on our cCOG objectives. In a way that: Promotes active patient and investigator participation in delivering quality research
in the UK. Vision:
To promote and facilitate commercial clinical research in the UK in partnership with NHS organisations to ensure highly competitive performance within the global arena by delivering to time and quality.
Objectives Session: From now until 13.45 – Form into 4 teams to review objectives and formulate an action plan to
achieve them. At 13.45, leaders from each team will present updates and/or a revised action plan (3-4 minutes
each)
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cCOG – Objectives for 2017 Site Readiness and Activation (new for 2017)
Raising Patient and Public Awareness of Clinical Trials (ongoing)
Data Quality in Clinical Trials (ongoing)
Support optimal Clinical Trial Conduct in the UK through a rapid, smooth
and clear HRA approval process both at study set up and amendments approvals (expanded from 2016)
Note: Rebranding of cCOG is in maintenance (not one of the four annual objectives, but not to be forgotten!)
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cCOG – Objectives for 2017 Site Readiness and Activation (new for 2017)
Site Readiness and activation group Sub group - Apps and technology - Graham Oakley
Survey will be sent to site Collate best practise
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cCOG – Objectives for 2017 Raising Patient and Public Awareness of Clinical Trials (ongoing) 1. Gillian Waite to contact Simon to explore current materials that are available to support
ICTD in our companies and share with cCOG members by 1 April. How did we do? 2. Invitation to be extended for a Patient Ambassador to attend the cCOG meeting in June,
share their experiences and then work with the sub team to explore practical ways as to how cCOG could work with these representatives in 2017. Scheduled for September meeting.
3. Understand the current NIHR initiatives regarding patient engagement by 1 April, with the aim to identify an initiative(s) that cCOG can support in 2017
4. Create more transparency between NHS and industry regarding patient engagement by cCOG providing a ‘tool kit’ of information for each company to work with.
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cCOG – Objectives for 2017 Data Quality in Clinical Trials (ongoing) Patient Electronic Records - Issue around printing source and do we know that all source has been printed.
- MHRA paper available – Roadmap are looking at this - please feedback to Lorraine Fincham
Data Quality - Janina Jezierski - subgroup Medical Records Survey monkey to be distributed to site to define key issue with data quality Site data management plan –Time to SIV, expectations around data Electronic medical records to be reviewed further .
ICH R2
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cCOG – Objectives for 2017 Support optimal Clinical Trial Conduct in the UK through a rapid, smooth
and clear HRA approval process both at study set up and amendments approvals (expanded from 2016)
4 main objectives - monitor timelines of trials set up HRA not extending will collect metrics from October – March
Working with HRA re good quality and timely communication on changes Seamless approvals across the UK - Devolved nations will map their process Continue two way feedback between HRA and industry to make improvements to the process on both sides. Group to collect info on PI’s that are new to commercial research re engagement - numbers only
CCOG
NHS Fax Removal Summary:
NHS Trusts seem to be actively removing Fax machines and associated analogue phone lines.
Sites that rely on sending/receiving fax can theoretically switch to email fax solutions, but it may not be going smoothly (e.g. if they don’t have scanners).
Other applications may also be affected if using the analogue lines (e.g. ECGs)
Action: cCOG has been asked whether the members have any experiences and/or
feedback we want to share with the Trusts.
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SIV Questionnaire For one of our objectives this year at cCOG, we have been tasked to make SIVs / TIVs
more effective. To do this, we need your help in gathering further information on how you currently
perform SIVs / TIVs. Please can I ask you to take a look at the attached questionnaire, and pass onto your
colleagues (CRAs, PMs etc) who have recently performed SIVs / TIVs: The questionnaire is easy to complete Only takes about 5-10 mins to answer Once answered, please can you email back to the cCOG inbox –
[email protected] Completed questionnaires are due by Friday 30th June, but if you don’t have time
before then, early the week after will suffice. All questionnaires will remain anonymous, and if you have any further questions, please
feel free to ask ([email protected]).
CCOG
Any Other Business Potential Discussion Points:
Recap of Charter Implications of Recent/Upcoming Changes on UK Clinical Research:
ICH GCP E6 R2 (Risk based monitoring, greater PI responsibility, etc.) Data Protection (Safe Harbour/Privacy Shield, GDPR) Brexit?
Any Other Business? .. .. ..
CCOG
Any Other Business Agenda Items for Next Meeting:
Review of SIV data? Patient Research Ambassadors Any others?
CCOG
End of Meeting Minutes to be distributed shortly, including list of actions. Next Meeting is 15th September – please contact the Chair if you have
suggestions for meeting topics/speakers!
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cCOG Operating Guidelines How we interact/communicate:
cCOG holds quarterly face to face meetings at the ABPI Offices, London. These may be supplemented by ad hoc team/sub-team teleconferences should the need arise.
Members are required to attend a minimum of 3 meetings annually in order to retain membership and absences should be covered by an appropriate delegate from their organisation.
Meeting minutes, including presentations from guest speakers (with their permission), will be distributed to all Member Companies.
cCOG will make available the cCOG Charter, list of Member Companies, a summary of the current year’s Objectives, listing of future Meeting Dates and details of meeting topics and presenters (by permission) after each meeting through postings on a designated cCOG area linked from the NHS Research Scotland (NRS) and Health and Care Research Wales website(s).
Topics covered will be posted within 1 week following each meeting. Members are encouraged to use the cCOG meeting minutes to provide cCOG updates to
colleagues and when representing cCOG at other forums/meetings (see below). Members represent cCOG through attendance at; R&D Forum, CREN, Road Map Group (RMG),
ICR and Costing Group meetings. It is noted that cCOG abide by the UK Competition Laws.
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cCOG – Rotating Chair Rotating Chair
Will be assigned during each meeting to host the following meeting, in liaison with our ABPI host. It was agreed that we would work alphabetically by company from A to Z.
The Chair is responsible for compiling the agenda, liaising with members to present news and updates and/or guest speakers covering topics identified by the members.
The Chair will distribute the agenda in advance of the meeting and support the logistics with our ABPI host. The Chair will collate speakers’ presentations in advance and chair the meeting. Checklist:
Confirm attendance/delegates attending (up to 30 people can fit in Alexander Fleming room) Book catering with ABPI (Belen) Confirm HRA, NIHR, NHS Research Scotland & Health and Care Research Wales as guest speakers Confirm updates from other industry groups will be available where possible (i.e. R&D Forum, RoadMap,
CREN, ICR, Costing group, etc). Arrange additional guest speakers or focus topics for internal speakers. Finalise and distribute agenda Compile presentations Chair the meeting / ensure timelines are kept.
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cCOG – Rotating Minute Taker / Members Rotating Minute Taker:
Assigned at each meeting to prepare for and take minutes during the meeting, using the cCOG meeting Minutes powerpoint template. Minutes will be distributed to members within 15 working days of the meeting. it was agreed that we would work alphabetically by company from Z to A (i.e. in reverse).
Members If unavailable to attend in person, members will ensure the ABPI host/rotating Chair
are informed in advance, providing details of their delegate. Members unable to attend at least 3 annual meetings should identify a replacement
from their Company or their Company will be withdrawn from membership of cCOG.
All members are required to actively support the cCOG meeting and objectives. If anyone would like to find out more about cCOG or wish to enquire about
membership - please feel free to contact: [email protected]
