FDA FOCUS: The need for open clinical trial data for FDA approval

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at whether transparent clinical trials could impact FDA approval.

There is a strong international trend, in both the medical community and the public, demanding transparency from the pharmaceutical industry in drug testing and approval procedures. Large organizations, like the World Health Organization and the US National Institute of Health, along with the US Congress, the European Commission, and many other organizations, have joined the call for sharing the results of clinical trials; some are even calling for all raw data to be made public.

It is anticipated that this movement will bring a significant change in the way new drugs are approved, tested, and even developed. This would allow the public and medical professionals to inform themselves and patients with considerably more thoroughness and less bias about the efficacy, as well as the pros and cons, of a drug. The scientific community would be able to use the results procured by other scientists in clinical trials without obstacles, thus saving time and resources in devising new treatments.