A major international study published in JAMA Network Open has identified practical actions that could improve the quality, usefulness, and reliability of randomised clinical trials around the world.
The research, conducted as part of the INFORM (Improving pre-funding peer review to increase the informativeness of randomized trials) project led by Professor Shaun Treweek, draws on interviews with 55 stakeholders from 16 countries across six continents, including trial investigators, funders, ethicists, regulators, industry representatives, and sponsors.
Clinical trials play a central role in guiding healthcare decisions, but poorly designed or delivered trials can fail to answer important clinical questions. The INFORM project was established to identify practical ways funders and researchers can improve trial informativeness and reduce research waste.
The study found broad international agreement that many clinical trials could be made more informative through stronger scientific review before funding decisions are finalized, better planning for recruitment and retention, improved training for trial teams, and more meaningful patient involvement throughout the research process.
Prof Treweek, Professor of Health Services Research at the University of Aberdeen, explains:
“A very large proportion of trials are not informative, in other words, they represent research waste, and waste of the goodwill of those who took part. Our study shows that there are plenty of ways of increasing the chance of an informative trial. What’s more, the things we identify are not rocket science. It’s hard to understand why they are not being done already.”
Dr Sarah Prowse, Research Fellow at the University of Aberdeen, and lead study author, notes:
“What stood out in these interviews was the amount of shared thinking across very different parts of the research system about how trials can be made more informative and less wasteful. Participants spoke about the importance of ensuring studies are realistic, relevant, and capable of producing evidence that will genuinely be useful in practice. Despite differences in role, geography, and healthcare systems, many participants described remarkably similar priorities.”
The findings contribute to the wider INFORM programme of work, including the development of the INFORM 12 Good Practice Actions — a set of practical recommendations designed to help funders and trial teams improve the informativeness of clinical trials from the earliest stages of planning and review.
A free package of training materials and supporting resources is also available to help organisations apply the INFORM findings in practice on the Trial Forge website: https://www.trialforge.org/inform/
Clarinda Cerejo, Patient Engagement Consultant and Fellow of the European Patients Academy on Therapeutic Innovation (EUPATI), who features in an INFORM Good Practice Action video discussing patient and community engagement in trials, said:
“Clinical trials represent hope and new possibilities for patients. This hope is crushed when clinical trials fail, which they do all too often for avoidable reasons. It's heartening to see the comprehensive and practical recommendations from the INFORM project. I believe that their adoption can lead to better trial design and implementation, and ultimately better patient outcomes globally.”
The INFORM project is funded by the Gates Foundation and aims to support more informative, ethical, and impactful clinical trials by improving how studies are reviewed before funding decisions are made.