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Mind the gap? The platform trial as a working environment
- Source :
- Trials, Vol 20, Iss 1, Pp 1-6 (2019), Trials
- Publication Year :
- 2019
- Publisher :
- BMC, 2019.
-
Abstract
- Background Trials 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. Commentary We 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 of routine and high-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. 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.
- Subjects :
- media_common.quotation_subject
Data management
Researcher
Medicine (miscellaneous)
Compassion
Efficiency
03 medical and health sciences
0302 clinical medicine
Resource (project management)
Loyalty
Humans
Medicine
Pharmacology (medical)
030212 general & internal medicine
Platform trial
media_common
Clinical Trials as Topic
lcsh:R5-920
business.industry
Adaptive design
Professional development
Precision medicine
Stratified medicine
Biomarker
Public relations
Clinical trial
Trial management
Research Design
Scale (social sciences)
Commentary
business
Qualitative
lcsh:Medicine (General)
030217 neurology & neurosurgery
Qualitative research
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 20
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....eae0b03e2c53e1c750a0c4d433125345