University College London (UCL) is the Sponsor for the OPTIMA trial.
Sponsor Protocol Number: 11/0479
Trial Management Group (TMG) and core Trial Management Group (cTMG)
The Trial Management Group (TMG) are responsible for trial design and monitoring trial progress. The TMG is a multidisciplinary team whose members include clinicians, statisticians, qualitative researchers, a translational scientist and a patient advocate, and has considerable expertise in all aspects of design, running, quality assurance and analysis of the trial. The core TMG (cTMG) consists of members of the TMG and the Warwick Clinical Trials Unit (WCTU) and is responsible for the day-to-day conduct of the trial. The TMG will report to the Trial Steering Committee through the cTMG.
Trial Steering Committee (TSC)
The Trial Steering Committee (TSC) is an oversight committee appointed by the Trial Funder. The TSC has an independent Chairperson and majority independent membership. The Chief Investigator and WCTU lead represent the TMG to the TSC. Additional members of the TMG are co-opted onto the TSC as appropriate. Regular (at least once a year) face to face meetings take place.
The TSC is responsible throughout the trial for:
- Proposals for substantial protocol amendments and provision of advice to the funder regarding approvals of such amendments
- Monitoring and supervising the progress of the trial
- Reviewing relevant information from other sources
- Considering recommendations from the Independent Data Monitoring Committee (IDMC)
- Informing and advising on all aspects of the trial
Independent Data Monitoring Committee (IDMC)
An Independent Data Monitoring Committee (IDMC) advises the Trial Steering Committee. The IDMC reviews the main trial for trial progress, recruitment, protocol compliance and interim assessment of outcomes, annually or more frequently if requested. The IDMC advises on the continuation of the trial, the need for amendments and whether OPTIMA should stop prematurely based on the trial data monitored and any future publications or emerging worldwide evidence.
NCRI Clinical Studies Group
National Cancer Research Institute (NCRI) Breast Clinical Studies Group (CSG) developed and approved the trial, and provided input into responses to reviewers of the funding applications.
Ethical and Health Research Authority approval
All required approvals have been obtained using the Integrated Research Application System. OPTIMA obtained ethical approval from the National Research Ethics Committee South East Coast - Surrey (NHS REC) in the UK.
Before enrolling patients into the trial, each trial site must ensure that the local conduct of the trial has the permission of the relevant NHS/Health and Social Care (HSC) Organisation’s research management function (e.g. R&D department). NHS/HSC management permission will be obtained through Health Research Authority (HRA) Approval for NHS Organisations in England and via the coordinated NHS/HSC permissions systems in the devolved administrations. UCL and WCTU will only activate a site to recruitment once written confirmation of the NHS/HSC Organisation’s permission to participate in the study has been received.
Non-UK sites require country-specific ethical approvals. UCL and WCTU require written confirmation that the necessary ethical approvals are in place before recruitment can commence. Responsibility for managing local approvals may be delegated to the country-specific coordinating centre where applicable.
OPTIMA is funded by a grant from the National Institute for Health Research (NIHR) Health Technology Assessment Programme (10/34/01, 10/34/501). Additional funding sources acquired to support non-UK recruitment and translational research projects will not affect the position of NIHR as the primary funder.