The European Medicines Agency (EMA) has now adopted its policy about access to clinical trial data,1 more than a year after the release of the first draft for public consultation.
Although intended to boost accountability and trust in medical research, the policy does not seem to meet such expectations. The main concern is with respect to which data and documents can be accessed. The policy applies only to dossiers submitted through the centralised procedures from 2015. Pharmacovigilance data are not deemed in the policy. Before publication, the holder of marketing authorisation could edit clinical overviews, study summaries, and reports to delete commercially confidential information—disclosure of such information might undermine a company’s economic interest. This redaction process could be assumed to only apply to trade secrets (eg, formulae, processes, and molecules), but might include advice offered by non-European regulatory authorities, plans for clinical development, or protocols agreed with non-European authorities and marketers.
The proprietary nature of any assay developed for analysis of a given product is a pretext not to release pharmacodynamic and pharmacokinetic data, as such information might give competitors a substantial advantage. Even information that helps to make the calculation for sample size (eg, estimates of endpoint variability, screening, and retention rates) might be confidential.
To read the article by The Lancet