Improving Trial Informativeness: A Rapid Review of Global Research on How to Ensure Trials Are Useful

Abstract

Rationale

Randomised controlled trials are considered the ‘gold standard’ in clinical research and decision-making. However, many trials have significant flaws that current review processes fail to identify early enough for corrections to be made. Flaws in trial design, conduct and reporting ultimately lead to research waste. This rapid review provides insights from global research aimed at improving trial ‘informativeness’ as described by Zarin and colleagues.

Methods

A rapid review was conducted with a focus on research addressing trial design processes that might improve informativeness aligned with one or more of the five key conditions outlined by Zarin and colleagues: 1) Importance, 2) Design, 3) Feasibility, 4) Integrity and 5) Reporting. A further thematic analysis was conducted using NVivo 12.

Results

The final review includes 42 texts. Of the 27 recommended processes or actions to improve trial informativeness, most were relevant to the second condition of trial design (2) Design; 44%). A key recommendation was the use of ‘tools’ to enhance trial informativeness. A total of 23 tools were identified across the conditions of 1) Importance (17%), 2) Design (74%) and 5) Reporting (9%).

Conclusion

This review highlights how a better understanding of design processes that lead to informative trials can reduce or eliminate research waste. Further research is needed on how these processes can better support pre-funding peer review, which would also increase the likelihood of producing informative trials.