Don’t backslide on trials transparency

Courts should not let companies keep data on medicines secret, says Ancel.la Santos

Clinical study reports, or CSRs, are the most extensive source of information about a clinical trial. They are hundreds or even thousands of pages long and detail the objectives of the trial, its design and its results.

CSRs are the cornerstone of the dossier that pharmaceutical companies submit to medicines agencies when seeking to put product on the market. This information, about the way a company has tested a medicine, whether it is safe and whether it works, is crucial for regulation and public health.