Trial Committees and Investigators

There are a number of committees involved with the oversight of the trial.

TRIAL MANAGEMENT GROUP (TMG)

The Trial Management Group (TMG) comprises the Chief Investigators, all trial chief investigators, other co-investigators (clinical and non-clinical), members with specific interests (e.g. pharmacist, nurse, user representative) and members of the MRC CTU. The TMG is responsible for the day-to-day running and management of the trial. It holds regular teleconferences and face-to-face meetings.

TRIAL STEERING COMMITTEE (TSC)

The Trial Steering Committee (TSC) has membership from the senior members of the TMG and representatives of the funder plus independent members, including the Chair. The role of the TSC is to provide overall supervision for the trial and provide advice through its independent Chair. The ultimate decision for the continuation of the trial lies with the TSC.

INDEPENDENT DATA MONITORING COMMITTEE (IDMC)

An Independent Data Monitoring Committee (IDMC) has been formed. The IDMC will be the only group who see the confidential, accumulating data for the trial. Reports to the IDMC are produced by the MRC CTU statisticians. The IDMC will consider data using the pre-agreed statistical analysis plan and will advise the TSC. The IDMC can recommend premature closure or reporting of the trials or discontinuation of recruitment to any research arm.

SITE EVALUATION COMMITTEE

A Site Evaluation committee has convened under the chairmanship of Professor Will Steward. All interested sites will submit a site evaluation form which will be reviewed by members of this committee with site visits performed if necessary. On the basis of their findings, they will classify each site with Level 1, 2 or 3 status.

COMMITTEE MEMBERSHIP

TRIAL MANAGEMENT COMMITTEE (TMG):

Member

Role

Professor Tim Maughan (Chair)

Overall Chief Investigator and CI for FOCUS4-N

Professor Richard Wilson (Co-Chair)

Overall Co-Chief Investigator and CI for FOCUS4-B and FOCUS4-C

Professor Gary Middleton

Chief Investigator for FOCUS4-A

Dr Kai-Keen Shiu

Chief Investigator for FOCUS4-A

Dr David Church

Chief Investigator for FOCUS4-B

Dr Richard Adams

Chief Investigator for FOCUS4-D

 

 

Dr Leslie Samuel

Lead for Scotland

Dr Harpreet Wasan

Co-Investigator

Professor Christian Ottensmeier

Co-Investigator

Jenny Seligmann

Clinical Research Fellow

Professor Richard Kaplan

MRC Programme Lead

Dr Louise Brown

MRC Project Lead & Senior Statistician

David Fisher

MRC Statistician

Krishna Letchemanan

MRC Trial Manager

Riya Bathia

MRC Trial Manager

Anna Bara

MRC Clinical Operations Manager

Stephanie Tsenti

MRC Data Manager

Alexander Maytum

MRC Data Manager

Kirsty Brown

MRC Trial Manager

Sandie Wellman

Nurse Specialist

Elizabeth Hodgkinson

Pharmacist

Professor Nicola Stoner

Pharmacist

Kristina Duggleby

NCRN representation

Dr Jane Beety

NCRN representation

Dr Meleri Morgan and Dr Fouad Alchami

Biomarker Panel - Cardiff

Dr Rachel Butler

Biomarker Panel - Cardiff

Professor Phil Quirke

Biomarker Panel - Leeds

Dr Susan Richman

Biomarker Panel - Leeds

Malcolm Pope

Patient/consumer representation

Janet Pope

Patient/consumer representation

TRIAL STEERING COMMITTEE (TSC):

Member Role
Professor Philip Johnson (Chair) Oncology
Professor Jeremy Whelan Oncology
Dr Robin Rudd Oncology
Ann Russell Patient and public representative

INDEPENDENT DATA MONITORING COMMITTEE (IDMC):

Member Role
Professor David Cameron (Chair) Oncology
Professor Robert Souhami Oncology
Dr Marc Peeters Oncology
Professor Cindy Bellingham Statistics

SITE EVALUATION COMMITTEE:

Members of the TMG sit on this committee as required.