# Do Funders, Regulators, and Ethics Bodies Support Informative Trials? A Content Analysis of Global Guidance Documents

## TL;DR

This study examines global guidance documents to see if they support well-designed clinical trials that provide useful evidence for healthcare.

## Contribution

The study identifies how guidance from funders, regulators, and ethics bodies supports or could better support informative trial design.

## Key findings

- Guidance on trial design and integrity is well represented in global documents.
- Feasibility guidance is limited compared to other aspects of trial informativeness.
- There is a need for more context-sensitive approaches to reduce bureaucratic burden.

## Abstract

Trials are often poorly designed, address unimportant questions, or are conducted in ways that limit their usefulness. This contributes to research waste and undermines evidence‐based healthcare. We examined whether guidance from funders, regulators, and ethics review bodies supports the planning and approval of informative trials, with a focus on resources available to investigators and the role of oversight organizations.

We conducted a directed qualitative content analysis of guidance documents from funders, regulators, and ethics review bodies across 13 countries and three multinational organizations. Documents were analysed using a coding framework based on the five conditions for trial informativeness identified by Zarin and colleagues: Importance, Design, Feasibility, Integrity, and Reporting.

The final content analysis contains 37 guiding documents, including 13 documents from funders, 14 from regulators, and 10 addressing the ethics of trials. While contextual examples varied, many of the recommended processes or actions to improve trial informativeness were consistent across global guidance from funders, regulators, and those with ethical oversight. The aspects of Design and Integrity were particularly well represented, whereas guidance on improving Feasibility was limited.

The five key aspects of trial informativeness were reasonably described in some capacity across all forms of guidance, but may benefit from further examples or elaboration. Further research is needed to explore how trial guidelines and other supporting documents might incorporate more flexible, context‐sensitive approaches that reduce bureaucratic burden without compromising ethical and scientific rigour.