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Commercial Clinical Operations Group (cCOG)

The Commercial Clinical Operations Group (CCOG) was formed to represent commercial sponsors and industry partners of clinical trials and 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 the 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.

Operating guidelines

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 presenter (by permission) after each meeting through postings on the cCOG area of the NHS Research Scotland (NRS) and Health & Care Research Wales website(s). cCOG information and updates can be found at the following links:

Members are encouraged to use the cCOG meeting minutes to provide cCOG updates with colleagues and when representing cCOG at other forums/meetings (see below).

Members represent cCOG through attendance at; R&D Forum, CREN, Road Map Group and Costing Group meetings. 

It is noted that cCOG abides by UK Competition Laws.

2018 meeting dates

Meeting dates for 2018 have been confirmed as:

  • Monday 5th February
  • Tuesday 12th June
  • Wednesday 26th September
  • Tuesday 12th December.

Topics covered will be posted within 1 month of the meeting.

Member companies

A list of member companies can be downloaded here.

 

Role and responsibilities

Rotating Chair: will be assigned at each meeting to host the following meeting, in liaison with our ABPI host.

  • The Chair is responsible for formulating 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 a minimum of 1 week in advance of the meeting and support the logistics with our ABPI host.
  • The Chair will collate speakers’ presentations in advance and host the meeting.

Rotating Minute Taker: assigned at each meeting to prepare for and take minutes during the meeting, using the cCOG meeting Minutes PowerPoint template, which will be distributed to members within 15 working days of the meeting.

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.

Non-sponsor members: Include representatives from ABPI, NIHR, NRS, Health & Care Research Wales and HRA representatives, who provide news and updates relevant to their organisation.

cCOG objectives

cCOG members have agreed that for 2018, objectives will not be set – instead, meetings will become more interactive and focus on opportunities to discuss hot topics, shared experiences and best practices.

Key Stakeholders

ABPI CREN RMG
R&D Forum HRA NIHR
NRS NICRN Health and Care Research Wales

2017 Meeting Overview

2017 Meeting Summary – Thursday 9th November, presenters detailed below have given consent to be contacted for more information in relation to topics.

Alastair Nicholson

Policy Development Lead for HRA, provided a brief update in relation to plans for IRAS, HRA is looking at an integrated approval process, which has been piloted with 6 MRECs – this new streamlined process will roll- out during 2018. The new mCTA is anticipated late November/early December.

Bill Davidson

Joint Head of Policy, HRA, provided an update on the General DP Regulations, which will be in effect from May 2018. EU guidance is expected January 2018 but will be preceded by UK Information Commission Offices overview next month [December].

Details will be posted on HRA website. See www.eugdpr.org for more information on GDPR.

Lydia Vitolo

Senior Industry Manager for Health and Care Research Wales, provided an update on the status of centralising contracting and costings across Welsh sites, with plans to be available from February 2018. New for Wales is the ‘Co-ordinated Oversight of Research Delivery’ (CORD), which will focus on performance and delivery of studies.

Steven Burke

Industry Liaison Manager for NRS, provided an overview of study placement and delivery in Scotland demonstrating excellent results. NRS reporting capabilities can provide average start-up data by sponsor/CRO (on request) and NRS vision is to provide greater support for research staff involved in trials.

Lorraine Fincham

Commercial Research Initiative Manager, provided an update on the pilot (phase 1) for aligned site identification process, which is now expanding to phase 2. Regular meetings are taking place with Devolved Administrations to monitor progress. The revised Site Intelligence form has been implemented following review with Road Map Group members and the ‘Early feedback’ form has also been modified.

Suki Balendra

Industry Ops Manager for CRN North West (NW) London, presented an update on the success of the contract and budget harmonisation project across NW Trusts. Six studies were included in the pilot between 2016/17.

 

cCOG members shared their experiences of NIHR support for studies across the 15 regions and provided feedback for the IOM meeting being held 22nd November. The intention is for Sponsors to have a better understanding of what CRNs are able to offer in their region to ensure transparency of service.

cCOG member updates for 2017 objectives:

  • Site Readiness and Activation – completed with the release of ‘Site Initiation Visit guidance for sponsors’ developed as a flyer and set of slides, which are available from cCOG area on Industry pages (see links above). The guidance was created based on results of a CRA survey and R&D feedback.
  • Raising Patient and Public Awareness of Clinical Trials – ‘Patient facing toolkit’ will be developed by end 2017 and maintained periodically - to include examples of patient recruitment and retention materials and case studies.
  • Data Quality in Clinical Trials – data management survey will be provided to CRN during IOM meeting in November. cCOG will review results early 2018 with the aim of improving metrics.
  • Support optimal Clinical Trial Conduct in the UK - flowcharts detailing the approval requirements/process, across the devolved nations will be available shortly, posted on the various websites (initially to cover study set up but plan to expand these to cover amendments as well) HRA (along with Scottish and Welsh counterparts in the devolved administrations) attended each of the cCOG meetings through 2017 to provide updates on process and improvements – member company cascaded this information within their companies.  Member companies were reminded that HRA welcome invitations to present updates with their teams, this has proved very helpful as the HRA processes have evolved and improved. Future opportunities include the development of ‘one nation costing template’. 

Hot topics

  • Members were made aware that some Trusts are requesting two-way confidentiality agreements.

Downloads

The next meeting will take place on: Monday 5 February 2018.

If you would like to find out more about cCOG or wish to enquire about membership - please feel free to contact us at CommercialCOG@outlook.com.