TranspariMED today publishes a case study detailing how a leading European university tackled the challenge of ensuring that all its clinical trials are registered and post their results onto registries.
The case study details how the University of Bristol approached the issue, discusses how it overcame various challenges along the way, and outlines future plans for embedding best practices in clinical trial transparency.
Key lessons learnt:
Start the process as soon as possible. Cleaning up registry entries can be a prolonged process, and the results of this work can take time to become publicly visible.
Create a central account for the institution from which clinical trial registration and the posting of summary results can be managed, with oversight and support from a core funded Research Governance Team.
Include registry maintenance in job descriptions and ensure that this area is resourced appropriately. Uploading data onto trial registries can be difficult and time consuming, and often requires specialist skills.
Use the WHO definition to identify clinical trials and ensure that trials are set up and run accordingly from the very beginning.
Actively engage with the administrators of trial registries and engage in best practice exchanges.
TranspariMED hopes that this case study will encourage other universities to follow Bristol’s positive example, and help them to navigate the process more effectively.
Please click on the image below to download the University of Bristol case study.
The case study was written by Dr Birgit Whitman, Head of Research Governance at the University of Bristol. Till Bruckner of TranspariMED contributed editorial input. The study is published under a Creative Commons license and may be freely shared and reproduced.
Additional clinical trial transparency tools for universities
TranspariMED’s quick primer on clinical trial registration and reporting rules and its clinical trial transparency policy checklist provide additional guidance for universities wishing to improve their clinical trial policies and practices.
The Clinical Trials Registration and Results Reporting Taskforce helps PRS administrators at universities and non-profits to navigate Clinicaltrials.gov. A European equivalent does not yet exist.