Paris, 14 November 2014

Joint response to World Health Organisation (WHO) public consultation (HAI Europe, ISDB, MiEF, Nordic Cochrane Centre, Public Citizen). In order to achieve ambitious global standards, this comprehensive WHO statement should capitalise even more on the significant recent advancements on data transparency.

> Click here to download the joint response (pdf, 450 Ko)

Key points of the joint reponse

• We welcome and strongly support this comprehensive WHO statement on public disclosure of clinical trial results. Granting public access to clinical trial results is a scientific, ethical, and moral responsibility.
   
• This WHO statement is particularly important in the current context of transparency, in which global standards are being set to support public disclosure of clinical data. This is in the interest of furthering science and protecting patients.
   
• We support the WHO position that the details of clinical trials are to be registered in a publicly available, freely accessible and searchable clinical trial registry before any clinical trial is initiated. We also agree that updating clinical trial registries is crucial, and insist that such registries should be user-friendly to maximise their potential.
   
• We also support the proposal to set reporting timeframes for clinical trial results. In addition to the reporting modality proposed by the WHO regarding publication in a peer reviewed journal within 18 months from the study completion, we recommend that all outcomes are posted on an open registry within 12 months and all clinical trial data are made publicly available (e.g. in the form of clinical study reports) within 30 months from the end of the trial. The WHO statement should capitalise on the significant advancements on data transparency that have been made in the European Union (EU) with the implementation of the new EU Regulation on clinical trials (Regulation (EU) No 536/2014). We also suggest centralising the posting of results on the WHO clinical trial registry to avoid results being split on several websites as proposed in the statement. In addition, we propose that public access to clinical trial data from all past clinical trials is ensured.
   
• In our specific comments, we also insist on the positive impact of public disclosure of clinical trial results to public health and provide evidence. A clear statement that clinical data cannot be considered commercially confidential information should be added.
   
• The WHO should be the principal institution that sets global standards and encourage Member States to develop and implement mechanisms that ensure public access to clinical trial data. It would also be useful to add a new section to the statement that lists best practices on data disclosure by different countries, medical journals and publishers (e.g. requesting that the data are made publicly available as a condition for publishing an article). Such standards should include dissuasive sanctions for non-adherence to these standards.

©HAI Europe, ISDB, Medicines in Europe Forum (MiEF), Nordic Cochrane Centre, Public Citizen November 2014

> Click here to download the joint response (pdf, 450 Ko)