Journal
TRIALS
Volume 20, Issue -, Pages -Publisher
BMC
DOI: 10.1186/s13063-019-3377-5
Keywords
Precision medicine; Stratified medicine; Biomarker; Platform trial; Trial management; Qualitative; Efficiency; Researcher; Adaptive design; Compassion
Categories
Funding
- Sir Halley Stewart Trust
- Healthcare Values Partnership, University of Oxford, as part of JH's project 'Compassion in Healthcare: Practical Policy for Civic Life' - Arts and Humanities Research Council [AH/N009770/1]
- stratified medicine consortium in colorectal cancer - Medical Research Council
- Cancer Research UK [MR/M016587/1]
- AHRC [AH/N009770/1] Funding Source: UKRI
- MRC [MC_UU_12023/4, MC_UU_12023/24] Funding Source: UKRI
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BackgroundTrials have become bigger and more complicated due to the complexity introduced by biomarker stratification, and the advent of multi-arm multi-stage trials, and 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 personal experience of individual researchers working on these trials.CommentaryWe found reports of high workloads, with potentially significant stress for individuals and with an impact on their career choices. We conclude that there was an initial underestimation 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 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 a mix ofroutine andhigh-profile work, and the changing nature of pivotal roles. Such demands present challenges for colleague relationships, by enhancing the potential for competition and by 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 caring for the researchers engaged in the research ecosystem who are aiming to produce much hoped-for advances in medical science.ConclusionsThere 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.
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