Transparency is an often-used term that means different things for different stakeholders and audiences. When it comes to clinical research studies — which ideally result in new or better drugs — arguments can be made on both sides whether more information sharing is a good thing.
In a February 2019 JAMA Oncology article, Thomas Hwang, a researcher at the Harvard Medical School, Boston, Massachusetts, and colleagues discussed recent changes in transparency policies in the United States, Canada, and the European Union, and their effect on cancer research and drug development. Hwang argued more transparency is generally a good idea, and that appropriate patient privacy and trade secrets can be maintained.1
Additionally, many patient advocates and researchers say the US Food and Drug Administration (FDA) must be more open about drug development.2,3 However, Hwang noted there has been extensive pushback from drug companies who do not want to make public any negative outcomes or share information that may help a competitor. The authors wrote, “in the absence of regulation, companies face powerful incentives against full disclosure of potentially negative information, particularly in competitive areas such as oncology.”
Unlike the FDA, which has been slow to get fully on board with clinical transparency, both the European Medicines Agency and Health Canada have proactively shared clinical study results (CSRs) for both approved and unapproved drugs. The EMA has released at least 50 CSRs since 2015; Health Canada is implementing a similar plan, which balances the need for patient privacy with the need to proactively inform the research community about trial data that support regulatory decision making.4
To date, the FDA has only implemented a pilot program to disclose some portions of CSRs for up to 9 recently approved drugs; the sponsors in these cases have voluntarily agreed to release this information.5 Other researchers and scholars have called on the FDA to proactively share more preclinical and postclinical trial data.6