The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials. The document also suggests ways to strengthen the clinical trial ecosystem and touches on improving enrollment of under-represented populations.
The guidance notes that “despite the widely recognized importance of clinical trials, 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 reasons may be that clinical trials were never done, or those that were done failed to produce scientifically-robust and clinically-relevant answers or the results were never published.”
The guidance was developed as part of a resolution of the 75th World Health Assembly (WHA). WHO’s Director-General invited public comment on how such an ecosystem should be defined during a public consultation in October‒November 2022…
