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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.

2017 meeting dates

Meeting dates for 2017 have been confirmed as:

  • Thursday 2nd February
  • Friday 23rd June
  • Friday 15th September
  • Thursday 9th November

Topics covered will be posted within 1 week following each meeting.

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 will agree to 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.

cCOG members confirmed 2017 objectives (at the meeting on 2 February 2017):

  • Site Readiness and Activation (NEW)
  • 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)

Key Stakeholders

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

2017 Meeting Overview

Meeting took place on Thursday 2nd February, presenters detailed below have given consent to be contacted for more information in relation to their topics.

Simon Denegri NIHR National Director for Patients and Public, presented details of the May 2017 International Clinical Trials Day and the UK Clinical Trials Gateway.
Alastair Nicholson HRA Policy Development Lead, provided updates on the mCTA development and the implications of MIA on clinical research and loaned equipment in England.
Dr Steve McSwiggan

Head of Commercial Research Services, Tayside Medical Sciences Centre, presented a review including how commercial SIVs are received at the Dundee clinical trial unit.

‘Ten Site Initiation Visits (SIV) conducted between Sept and Dec 2016 for commercial trials commencing in NHS Tayside were reviewed for number of staff attending, duration of visit, the cost to NHS to accommodate and whether the Regulatory Green Light to commence recruitment followed soon after the SIV. Presenters were also rated by those attending the SIV.

The review was conducted as the efficiencies we have demonstrated in study review times [in Scotland] have largely not translated into more rapid site set up. We set out to get some baseline data on SIVs and to determine if ‘preparedness to start’ the study could be improved. In today’s tight financial climate we require some evidence and understanding of the real costs to the NHS of delivering clinical trials and set out to examine that by looking at how we accommodate SIVs as it is a relatively simple and controlled metric to calculate.’

Lydia Vitolo Senior Industry Manager presented updates for Health and Care Research Wales
Steven Burke  Industry Liaison Manager presented updates for NHS Research Scotland
Lorraine Fincham  Commercial Research Initiative Manager, presented an NIHR update including details of a single feasibility service across the devolved administrations.

The next meeting will take place on: 23 June 2017.

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.