In a CMAJ news article,1 Goldacre overlooks the estimated 30% to 50% of clinical trials that are submitted to the US Food and Drug Administration (FDA) in support of new drug approvals. These trials remain unpublished and have been available on the agency’s website free of charge since 1998.2–4 These documents are called “approval packages” and are detailed analyses conducted by FDA scientists. These packages must be made available to the public under the US Freedom of Information Act.
Regrettably, approval packages are infrequently used, throwing into question the validity of review articles based on the published literature, including meta-analyses, economic analyses and clinical practice guidelines.
Approval packages are much more than simple reviews of data submitted by manufacturers. They contain the number of events, benefits and harms, which is critical in assessing the therapeutic value of new drugs.
It remains to be seen what effect the Protecting Canadians from Unsafe Drugs Act will have on clinical trial transparency in the near term. In the interim, Canadians can access much of the information the AllTrials campaign is advocating for on the FDA website.