PUBLICATION: New policy for clinical study reports – University of Copenhagen

Center for Synthetic Biology > News > PUBLICATION: New polic...

07 August 2015

PUBLICATION: New policy for clinical study reports


Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nicholson Price II, W. and Minssen, T. Nature Biotechnology, 33, pp 685–686.doi:10.1038/nbt.3243 (2015)

Read the full article here

Last October, the European Medicines Agency (EMA) adopted a new policy that clinical study reports (CSRs) submitted as part of a marketing application in 2015 or later will be published—with redactions of commercially confidential information—once a decision is made on the application1. Earlier in 2014, the European Parliament and Council passed a regulation to similar effect2. Meanwhile, the US Food and Drug Administration (FDA) has proposed new rules that would require disclosure of masked and de-identified patient-level data3.

The drug industry has responded with its own transparency projects, including initiatives by GlaxoSmithKline, AstraZeneca, Sanofi, Pfizer and others4. These developments reflect a growing policy consensus favoring disclosure, which promotes independent verification of drug safety and efficacy data, provides a better framework for precompetitive collaboration and increases public trust in drugs and industry and the possibility of facilitating large cross-border clinical trials for, inter alia, rare diseases5.

Despite these benefits, the costs and concerns associated with opening up trial data are also substantial—for patients (patient privacy), for research (related to misuse of clinical trial data in poor-quality analyses) and for industry (fewer incentives to invest in innovative R&D owing to reduced competitive edge and increased exposure to litigation owing to trolling of these data by class-action tort lawyers)6. Here we highlight another area where clinical trial disclosure may have adverse effects: the development of new uses for already approved drugs5.