Trial committees and Investigators

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
Professor Matthew Seymour	Co-Chief Investigator for FOCUS4-C
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
Emma Yates	MRC Trial Manager
Marta Campos	MRC Clinical Operations Manager
Bartłomiej Przybył	MRC Data Manager
Sierra Santana	MRC Data 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.

FOCUS4

MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
90 High Holborn
2nd Floor
London
WC1V 6LJ

Email. mrcctu.focus4@ucl.ac.uk