The World Health Organization (WHO) is seeking public comments on a new draft guidance that aims to propose best practices for designing and conducting clinical trials, bolster the global clinical trial ecosystem and aid enrollment of diverse trial populations.

The guidance, development of which was agreed upon at the 75th World Health Assembly in May 2022, is aimed at ensuring trials have a strong evidence base, are scientifically robust and clinically relevant.

Despite clinical research’s recognized importance, “in many areas of health the evidence base remains weak, with decision-making processes lacking results from well-designed and well-conducted clinical trials,” the 54-page document says.

“The result can be failure to identify and use effective interventions or the continuing use of ineffective or hazardous interventions. This can lead to research waste, cause unnecessary harm or suffering, and reduce trust in those who develop or use health interventions,” WHO continued.

The guidance lists 12 features needed for strong trials:

1. Appropriate trial populations;
2. Robust randomization;
3. Adequate size;
4. Blinding and masking of the intervention(s);
5. Adherence to the trial intervention(s);
6. Completeness of participant follow-up;
7. Relevant measures of outcomes;
8. Proportionate, efficient and reliable data capture;
9. The same outcome assessments for all randomized groups;
10. Statistical analysis;
11. Assessment of beneficial and harmful intervention effects; and
12. Data monitoring for safety and effectiveness.

WHO will accept comments through an online form until Sept. 15. It hopes to receive feedback from public and private researchers, national health authorities, trial registries, ethics committees, regulatory agencies, patient/community advocates, professional associations, healthcare practitioners, and other stakeholders.

Read more about the guidance and comment submission here.