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Improving Trial Informativeness: A Rapid Review of Global Research on How to Ensure Trials Are Useful
Sarah R Prowse1, Shaun Treweek1, Miriam Brazzelli1
1Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
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.
Insights
Improving the informativeness of randomized controlled trials (RCTs) can significantly reduce research waste. This review identifies key design processes and tools to enhance RCT quality and impact.
Area of Science:
- Clinical Research
- Evidence-Based Medicine
- Health Sciences
Background:
- Randomized controlled trials (RCTs) are crucial for clinical decision-making but often suffer from flaws.
- Current review processes inadequately identify and correct these flaws early.
- Trial design, conduct, and reporting issues lead to substantial research waste.
Purpose of the Study:
- To provide insights from global research on improving the informativeness of RCTs.
- To identify processes and tools that enhance trial design, feasibility, integrity, and reporting.
- To align findings with the five key conditions for informative trials outlined by Zarin and colleagues.
Main Methods:
- A rapid review methodology was employed.
- Focus was placed on research addressing trial design processes for improved informativeness.
- Thematic analysis was conducted using NVivo 12, referencing Zarin's five conditions: Importance, Design, Feasibility, Integrity, and Reporting.
Main Results:
- The review analyzed 42 texts, identifying 27 recommended processes to improve trial informativeness.
- Most recommendations (44%) pertained to trial design.
- Twenty-three tools were identified to enhance trial informativeness across Importance (17%), Design (74%), and Reporting (9%).
Conclusions:
- Enhanced understanding of design processes can reduce research waste by improving trial informativeness.
- Further research is needed to integrate these processes into pre-funding peer review.
- Implementing these strategies increases the likelihood of producing informative and impactful clinical trials.
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