Mind the gap? The platform trial as a working environment
MORRELL L., HORDERN J., Brown L., Sydes MR., Amos CL., Kaplan RS., Parmar MKB., MAUGHAN TS.
Background: Trials have become bigger and more complicated with the complexity introduced by biomarker stratification, and the advent of multi-arm multi-stage trials, umbrella and basket platform designs. The trials unit at University College London has been at the forefront of this work, with ground-breaking trials such as STAMPEDE and FOCUS4. The trial management and data management teams on these trials have summarised the operational challenges, to enable the broader clinical trials community to learn from their experiences. In a small-scale qualitative study, we examined the platform trial as a working environment, and its impact on the individual researchers. Commentary: We found reports of high workloads, with potentially significant stress for individuals and impact on career choices. We conclude that there was an initial under-estimation of the work required, and of the inherent, largely unanticipated, challenges. We discuss the importance of fully understanding these trials’ resource requirements, both for those writing grant applications and critically, for those with responsibility for deciding on funding. The working environment itself was characterised by three features: complexity, scale, and heightened expectations. These features are highly attractive for professional development and engender high levels of loyalty and commitment. We observed a trade-off between these intrinsic rewards, and the continuous demands of overlapping tasks, balancing the routine with the high-profile, and the changing nature of pivotal roles. Such demands present challenges for colleague relationships, by enhancing the potential for competition, and disrupting the natural opportunities to pause, review, and celebrate team achievements. In addition, molecular stratification in effect brings the patient into the trial office, as a specific individual, despite anonymisation, who is owed test results and a treatment decision. We discuss these observations with a view to interconnecting the need for compassion for patients with care of researchers engaged in the research ecosystem aiming to produce much hoped-for advances in medical science. Conclusions: There is a need for increased awareness of the challenge these studies place on those throughout the team delivering the study. Such considerations must influence leaders and funders, both in their initial budget considerations, and throughout delivery.