Work Package 3: The BETTER-B Main Trial

The BETTER-B Main Trial, an international, multicentre, randomised, placebo-controlled, double-blind, mixed methods Phase III pragmatic clinical trial.

Lead: King's College London (KCL)

Professor Irene Higginson leads this WP supported by the co-sponsors from KCL and UCD, LEEDS CTRU and all partners involved in recruitment (partners 1-3 and 5-9). This WP focuses on the leadership and delivery of the BETTER-B Main Trial, its sponsorship, adherence to Good Clinical Practice, recruitment, data collection and follow-up. It implements the procedures established in the trial set-up (WP2) and integrates the findings from WP1 to enhance recruitment and feasibility and feeds into WPs 4 and 5.

Objectives:

1. To initiate the BETTER-B Main Trial and ensure it runs according to Good Clinical Practice (GCP) and best ethical and trial procedures as set out in the EU Clinical Trials Directive, other relevant legislation and in CONSORT recommendations
2. To ensure timely and safe delivery and storage of Investigational Medicinal Products (IMPs) at all centres, first wave prior to initiation, subsequent deliveries on schedule
3. To monitor the sites in terms of recruitment rates, adherence to EU Directive and best procedures, quality data collection, including audits of procedures, governance and data collection and accuracy
4. To prepare reports on trial progress for relevant committees and bodies
5. To deliver mandated deliverables 2 and 3
6. To ensure analysis of all the trial data, appropriate interpretation and reporting and maximise the value for the EU, including posting of the results.