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.
The draft resolution published today includes the following items on clinical trial transparency:
Introducing grant conditions for funding clinical trials to encourage the use of standardized data protocols where available and appropriate and to mandate registration in a publicly available clinical trial registry within the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) or any other registry that meets its standards.
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.
According to Knowledge Ecology International, member states have already “reached consensus” on the text published today, which differs in several aspects from an earlier draft.
TranspariMED will publish a detailed analysis once the final text has been formally approved.
Some of the largest non-profit research groups in the world have already welcomed the resolution, based on the earlier draft text. Access to medicines advocates have been more critical.
The WHA75 clinical trial resolution is co-sponsored by Argentina, Peru, and the UK. All three countries were hit exceptionally hard by Covid. The UK gained a lot of attention during the pandemic due to its excellent Covid clinical research programme, which avoided the ‘research chaos’ and research waste common in other countries.
The resolution’s draft text is available online.