WHA clinical trial resolution: draft text now public

“The World Health Organization today published the draft text of the clinical trial resolution being debated at the ongoing World Health Assembly.

 

 

The resolution’s overall aim is to improve the coordination, design, conduct and reporting of clinical trials worldwide. It was partly spurred by the realisation that hundreds – maybe thousands – of Covid clinical trials have ended up as costly research waste….

 

Promoting, as appropriate, measures to facilitate the timely reporting of both positive and negative interpretable clinical trial results in alignment with the WHO joint statement on public disclosure of results from clinical trials and the WHO joint statement on transparency and data integrity, including through registering the results on a publicly available clinical trial registry within the [global trial registry network] ICTRP, and encouraging timely publication of the trial results preferably in an open-access publication.

Exploring measures during public health emergencies of international concern to encourage researchers to rapidly and responsibly share interpretable results of clinical trials, including negative results, with national regulatory bodies or other appropriate authorities, including WHO for clinical guideline development and emergency use listing (EUL), to support rapid regulatory decision-making and emergency adaptation of clinical and public health guidelines as appropriate, including through pre-print publication. …”