ccog meeting minutes june 2017 - health and care research ...€¦ · ccog welcome and introduction...
TRANSCRIPT
23rd June 2017
Chair - Daniel Clutterbuck (Allergan)Minutes - Janina Jezierski (Sanofi)
cCOG MeetingMinutes
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
• Guest Speakers – 23 June. 2017
Alastair Nicholson Policy Development Lead – HRA Assessment and Approval
Janet Messer Director of Research Systems, Standards & HRA Approval Programme
Lorraine Fincham Commercial Research Initiative Manager, NIHR
Lydia Vitolo Senior Industry Manager, Health and Care Research Wales
Belen Granell Villen Clinical Research and Regulatory Policy Officer, ABPI
• Next meeting : Friday 15th September 2017
Chair – BMS (postpone) swap with Biogen? TBC – DC emailed Katie/Ashlee to confirm if they have swapped.
Minute taker – Roche (postpone) PRA –Thijs Schreuder
Reminder: cCOG does not discuss specific Trusts or sites.
CCOG
Welcome and IntroductionCompan
y
Main Representative Obj Attending 23 Jun 2017 Main Rep Email (Stand-in in brackets where applicable)
AbbVie Liz Sheasby 2 Yes [email protected]
Allergan Dan Clutterbuck 2 Yes [email protected]
Amgen Sarah Durston 1 Yes [email protected]
Astellas Darleen Ewen 3 Yes [email protected]
Astra
Zeneca
Sophie Gillmore 4 No [email protected]
Bayer Gillian Waite (Lisa
Ferris)
2 Stand-in [email protected] ([email protected])
Biogen Sarah Deeley ? No [email protected]
BMS Katie Ellegard (
+ Ashlee Lucas)
4 Yes x2 [email protected] / [email protected]
Boehring
er-
Ingelhei
m
Graham Oakley (Toni
Edmonds)
1 Stand-in [email protected] or
Chiltern Emma Massie 4 Yes [email protected]
Covance Hannah Wilding 3 Yes [email protected]
Gilead Charlotte Vigor ? No [email protected]
GSK Martin Gill 3 Yes [email protected]
CCOG
Welcome and IntroductionCompany Main
Representative
Ob
j
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 Roberto Scarano 2 Yes [email protected]
MSD Emma Whelan
(Charlotte
McIntosh)
3 Stand-in [email protected] ([email protected])
Novartis Jane Lindsay
(Philips Ross)
4 Stand-in [email protected] ([email protected])
Novo
Nordisk
Pauline Szczerbicki 2 Stand-in [email protected] ([email protected])
Orion Steve Hietschold New rep from Simbec-Orion? [email protected]
Pfizer Nyree Forton 1 Yes [email protected]
PPD Hugh Devine 1 Yes [email protected]
PRA Thijs Schreuder 1 Yes [email protected]
Quintile
s
Donna Kapaya 2 Yes [email protected]
Roche Catherine Roynette 4 Yes [email protected]
Sanofi Janina Jezierski 3 Yes [email protected]
Servier Helen Whitrow ? No [email protected]
CCOG
HRA UpdateAlistair Nicholson & Janet Messer mCTA –
met with ABPI 6 months ago and agreed to push forward – consolidated feedback Dec 15 consultation and presented a version to ABPI. CREN meeting 15th May to discuss the draft.
Meeting 22 May HRA and devolved administrations to discuss feedback from CREN. Another meeting 2nd August.
Aiming for a single CTA for all nations rather than one for each nation.
Revised version for legal review in England followed by devolved nations by the end of the year.
Formal ongoing review mechanism to be put in place
CCOG
HRA Update Alastair Nicholson Master indemnity Agreement – update to the guidance has gone live on
the DoH website
Option of using the MIA for equipment that is not the subject of a clinical trial or a modified mCTA to cover this
Feedback to Alastair if sites are pushing back
MIA is time limited – check that registration has not lapsed
CCOG
HRA Update - New HRA Web Site Janet Messer Changes to the HRA website
Current website is currently out of date; users finding it difficult to find information
New website has been designed with multiple types of end users in mind
Three main sections
Approvals and amendments
Improving research
About us
Information has been moved to the IRAS website – HRA Website will have signposts to that information
CCOG
HRA Update – New HRA WebsiteJanet Messer IRAS Help Section is being worked on
Testing will be done to make sure it is right
Intent is for it to be mobile friendly
Expect to launch the new website in Late July – beta site from early July (link from existing website)
Feedback to [email protected]
CCOG
HRA Update Combined IRAS form Combined IRAS form from 28 June 2017
CCOG
HRA Update Questions Q from BI: Generic confidentiality agreement for the UK – is there any advance – being led by Kate by R&D Forum – Kate Greenwood to be invited to cCOG as standard going forward Q from BMS Non Substantial Amendments – do they only go to the HRA and not EC
Clarity – Sponsor’s responsibility y to determine SA versus NSA. Form for NSA – exists for the sites rather than the EC. NSA to studies led from England send only to HRA not to EC.
Guidance is in on the IRAS website Update from Astellas – causing issues with internal audits as letters from some sites and not from others
Q from BMS Capacity and Capability Letters on Amendments - sites are insisting on sending them (following local SOPS) – telling us we cannot assume we can implement them – HRA are still working on this please send names of Trusts to Janet Messer
Q from Roche- when does the 40/70 day clock start for set up at site? Trusts are waiting to start the clock not starting with the initial assessment letter and document pack Trust Feedback to local CRN Industry Manager – followed by the coordinating centre – there is an escalation route (LF to forward
timelines and escalation process)
Q from BMS – flow diagrams on website are from 2014 are they up to date – yes but will be under review shortly
Q from MSD - When can we implement the IB at the site when EC have asked questions about the PIS risk language that reflects the updated IB – can we use the IB without the updated PIS - should we split the amendments out? General discussion response was no
CCOG
NRS Update(sent in by Steven Burke) NRS Website has been upgraded
NRS working with cCOG looking at start up within the UK
MCTA - NRS working with HRA and ABPI to update the mCTA
Working on a UK Feasibility Pilot
Questions to [email protected]
CCOG
NIHR UpdateLorraine Fincham CRN is continually improving their support
Review of site intelligence service – streamlined the form; should be a quicker service. Local feedback on how the site has performed recently, met targets etc. hope to be signed off 5th July
Early feedback service review – new form expected end of July TBC
Study Support Service Organised and clarified the service – see website
CPMS and Devolved Administrations (for site Identification) Scotland, NI and Wales will be their own LCRNs CPMS – will now have NI Wales and Scotland – UK wide site identification service
Testing from 31 July 2017 – with 3 Sponsors and 1 CRO Phase 2 to follow (after 25 studies have gone through or three months) with 3 more companies,
then Phase 3
CCOG
NIHR Update Questions Q from GSK: CPMS website has been glitchy with log in/attachments – is
there an update to the website? Seems to have resolved itself
Feedback any issues to Lorraine Fincham or contact ‘supportmystudy’ helpdesk
CCOG
Wales UpdateLydia Vitolo, Senior Industry Manager Model for one cost one contract for Wales (similar to Scotland) work is
still ongoing
Developing a capability statement – brochure/online resource to be available around September 2017
UK Feasibility pilot – those not in the pilot please reach out to Wales to submit the feasibility
Working on flow charts for amendments and approval processes in Wales – will be circulated. If in doubt contact the Wales team [email protected]
eHealth records – any difficulties with setting up sites – please feedback
CCOG
RebrandingSarah Durston cCOG website hosted on Wales and NRS Website
CCOG
Other Member Groups UpdateR&D Forum No update this week -
CCOG
Other Member Groups UpdateRoad Map NIHR Performance 2016/17 Commercial trials under NIHR (England) delivered ~34,500 patients to CTs (including non-commercial
this is ~667,000 patients). Overall number of studies on the portfolio has increased – suggesting overall fewer patients per trial. 650 new studies were started in 2016/17 and 73% of commercial studies are tracked as delivering to time
and target (83% non-commercial studies). 1 NHS Trust are not involved in any research, and 79% of Trusts are involved in commercial trials. 48% of GPs are involved in research. >28,000 patients were randomised into CNS related studies. New metrics for 2016/17 year – 60% of studies set up ALL SITES in 40 days (from receiving initial document
pack (inc HRA validation letter) to signed contract) and 36% of sites randomised 1st patient within 30 days of signed contract (commercial trials).
Studies planned to recruit <12 patients a year are excluded from this second measure. Suggestion – when sending core document set to site staff, copy the CRN representative so they are
aware of timelines!
CCOG
Other Member Groups UpdateRoad Map Plans for NIHR in 2017/18 – to improve the customer experience when engaging with ‘support-
my-study’. All regions now have software that means NIHR receive high level details for all portfolio
studies. All sites R&D will be entering study data in ‘near time’ (live from end June ’17??) – this means that sponsors will no longer need to complete study milestone reports each month, instead sponsors will have access to the electronic data and be required to validate data entered by R&D.
Overall improved visibility for CRN - encourage sponsor to actively engage with networks from the start!
Future Objectives – Aim to utilise NHS data to support feasibility better – eg incidence and geographical occurence
of indication. HRA to be more aware of what local R&Ds/Trusts are doing Embrace digital interventions in CTs
CCOG
Other Member Groups UpdateRoad Map
Devolved Administrations
Ongoing meetings between devolved nations to simplify/streamline their services so one application covers all/select nations based on sponsors desire – UK wide focus. Meeting June to finalise the proposals.
Intention is that the non-confidential information will be sent direct to NI/Wales/NRS as if they were a ‘region in England’ to perform high level feasibility and offering expressions of interest (EoI). Aim to pilot this with selection of companies (based on volume of studies in last 12 months).
Single national approval next area of focus! There is a strong desire to have a single HRA like approval across all nations – watch and wait!
Feedback – some Welsh sites are refusing to review contracts without HRA approval in place – feedback to Lydia Vitolo as HRA currently does not apply in Wales!
CCOG
Other Member Groups UpdateRoad Map Workshop Early Feasibility, Site intelligence Services – The early feasibility form was adapted based on feedback that experts required to complete the
form are not very engaged/do not see any benefits. As a consequence the value of information returned may not be that accurate/worthwhile. The changes included setting the scene on status of study (early study design/landscaping versus final protocol) and option for expert to add details if interested in the study / willing to be contacted further. Questions were combined and clarified.
Site intelligence – sites already selected by a sponsor are required to complete details through site intelligence and often ask why as they are already involved. The purpose is unclear and sponsors agreed that the value of the form is limited. Decision that the real benefit would be for CRN to return ‘concerns’ they are aware of directly to the sponsor (eg this site have never recruited a patient in this indication before!) as a report. Format of report to be investigated –further details to be taken to cCOG meeting June.
It is important that CRN are aware of all sites selected and if new sites are added during start-up/conduct, CRN should be contacted to provide feedback. Engagement throughout life of study will add benefit.
CCOG
Other Member Groups UpdateRoad Map Hot Topics! Equipment Indemnity – confusion still high – DH will shortly be publishing clarification for
England regarding MIA and CT equipment loaned. Industry urge that once a common process is defined NHS and industry receive full training/awareness to ensure individual sites do not work outside the agreement. Willingness of sponsors to sign up to MIA.
Revised mCTA is likely to include wording taken from Pfizer contracts – unlikely this will offer a firm solution.
mCTA – meeting ABPI/Industry sponsors 15th May to attempt to define next version with HRA/CREN meeting 22nd May to ‘finalise’. How do other countries manage – eg. France have a single contract that is stipulated in their regulations – a copy will be shared to RMG, however apparently French sites push back on using it !! Scotland have a mCTA approved by Scottish health boards (but not industry!!).
EMR – Martin was not able to join, request to share sponsor’s wish list for what Trusts need to support CTs – to send comments to NIHR rep by end May for June 8th meeting. Amgen already informed.
CCOG
Other Member Groups UpdateRoad Map AOB
MREC requesting patient review of ICF – to note that NIHR patient ambassadors could be utilised to review ICF prior to MREC submission –may be able to provide faster turnaround than interacting with patient group charities (though value would depend on indication!). May be worth proposing this through the CI lead CRN contact at start of trial to see if this could be arranged!
Sites insisting on issuing C&C before activation/PA implementation –loop in local CRN in addition to escalating to HRA.
CCOG
Other Member Groups UpdateCREN mCTA update Credentialing – system which will not be mandatory for the Trusts
–used for company employees to enter the hospital premises One central System 3 tiers of access Hospital Reps first and then other company representatives – potentially CRAs Gradually Trusts will adopt this accreditation Costs per staff £30-50 Details to be worked out ABPI will provide training Feedback to Janet Messer for any questions pertaining to this considering
implications for research Belen will clarify the costs
CCOG
Other Member Groups UpdateICR No update for some time – to be removed from the agenda
CCOG
Other Member Groups UpdateCosting Group New template released 20th April 2017
Invoicing elements removed
Removed macros/coding
R&D, CI, Pharmacy and archiving fees increased to reflect actual expenditure
CCOG
cCOG 2017 Objectives
(1) Site Readiness and Activation (new for 2017)
Survey has been distributed (will be re-sent to updated distribution list)
Extending the timeline for responses to the end of July
Team will review and analyse data/make proposals to share at September cCOG meeting
Proposal to engage Stephen McSwiggan (Dundee) to share outputs based on his R&D/site perspective
Proposal to present data to future R&D Forum
CCOG
cCOG 2017 Objectives
(2) Raising Patient and Public Awareness of Clinical Trials (ongoing) (Donna)
NIHR website has a lot of information :
https://www.nihr.ac.uk/news-and-events/support-our-campaigns/i-am-research/
ICTD days 18th may – cCOG members feedback on initiatives mixed some undertook local events but most did not. Also leaflet ordering did not happen in some cases, not sure why, but the new ones are available if people wish to order now.
Action Lisa( bayer ) to review ‘I am Research’ website and feedback.
Lorraine Fincham to also review campaigns
The NIHR are also showing a film around the UK called “people are messy” about clinical trials.
PT ambassadors attending Sept cCOG meeting - q to ask them :
Tell us what you do
How can industry support/ help you
How do you connect with other patients / public
Any other questions should be sent to chair
EUPATI - European patients academy https://www.eupati.eu/
European patients advocacy group which help to review protocols and other regulatory aspects of CTIMPS – Lisa (bayer) will review this site also.
Acurian have approach BD at NIHR to help with brokering relationships between them and sites to help aid recruitment drives. Lorraine Finchham to feedback on this. Lorraine will also feedback on the possibility of sharing results on a survey completed by the CRN on patients feels on being on clinical trials.
CCOG
cCOG 2017 Objectives
(3) Data Quality in Clinical Trials (ongoing)
Questionnaire drafted and tested with a subset of sites – some interesting feedback
Team to meet and tweak the questions before distributing to a wider audience
Team to engage with NIHR with a view to improving UK metrics
CCOG
cCOG 2017 Objectives
(4) 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 – we have in conjuction with Scotland and Wales representatives created a draft flow diagram of the initial amendment process. This was presented to the HRA working group at the meeting. Working group members will take this and review with their colleagues to ensure this is clear and consistent. A process flow diagram of the Substantial Amendment Process is also being created but has yet to be presented to the cCOG HRA working group.
Continue two way feedback between HRA and industry to make improvements to the process on both sides.
CCOG
AOB Current Member – if there is an error for your company please let Dan Clutterbuck know – Sarah
Durston will keep the list updated Orion have merged with Simbec, Simbec want to join (Lydia Vitolo may have contact details) Servier no show – Lorraine Fincham will follow up Costing template validation prior to submission to HRA for portfolio studies –validation is not
about finite costs it is to confirm that all procedures are on the costing template Recap of Charter – See cCOG website for this. Data Protection Regulation (GDPR) & Privacy Shield:
Major changes in Data Protection in the last year and next year. Some companies have consent forms / log in for site staff for keeping data, but site staff do not
understand why they are asking for it. Current approach to data protection seems highly variable. See www.eugdpr.org for more information on GDPR. All members to ask local Legal and/or their Data Protection Officer for advice/information to see
if/how these are being addressed.
CCOG
AOB Q Abbvie: Patient 24 hour contact numbers for sites – does any one test them?
Increasing issues with them failing, sites refusing to give them – referring to 111; Some companies have a 24 hour number for this purpose??
Q Bayer: A site has introduced standard academic Chief Investigator Fees – as they are costing twice as much to the Trust – any one else encountered this? Feedback to Laura @ CRN
Q Thijs – A children hospital has asked for CRAs on a paediatric trial need to be CRB/DBS checked - take back to LCRN Manager to follow up for more details
Q GSK – eTMF – certifying CVs - CRAs photocopying, signing to certifying that it is original and then uploading – is anyone else encountering this?
CCOG
NHS Fax Removal NHS policy is to strip out the fax machines
General feedback is that this is not causing a significant problem to Clinical Trial setup (e.g. as sites are typically replacing traditional fax with an e-Fax solution with the same fax numbers).
CCOG
Topics for Next Meeting Patient Ambassadors
Data Protection Regulation: Safe Harbour/Privacy Shield – what does it mean for us?
Review of SIV data
Review of Data Quality Data (maybe for November)
CCOG
Summary of Actions Changes to representative - Sarah Durston
Temporary Changes email the Chair
Patient Ambassadors will be attending the next meeting
Please ensure that submissions to HRA include a VALIDATED costing template – assessment will not commence until this has been received
Agenda items to Dan C [until next Chair confirmed]