Clinical Trial Sponsors Fail to Report Results to Participants, Public

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publicly available, according to Duke Medicine researchers.

Among all clinical trials of medical products, those funded by industry were the most likely to be publicly disclosed in a timely fashion, but even then, compliance was poor. Research funded by the National Institutes of Health and academic institutions lagged further, according to findings published by Duke Medicine researchers in the March 12, 2015, issue of The New England Journal of Medicine.

Study authors said the lack of transparency by industry, federal funders and academia has created a critical information gap about investigational drugs, devices and biologic therapies that not only hampers progress, but also violates obligations to patients.

“Patients who participate in clinical research have the expectation that the risk of participation will be offset by the creation of generalizable knowledge and the advancement of science, and that is achieved through the availability of clinical trial results,” said lead author Monique Anderson, M.D., cardiologist and researcher at the Duke Clinical Research Institute. “Sponsors who lead clinical trials have an ethical and legal obligation to publicly report their findings, whether the results are positive or negative.”

To read the press release in full, click here.

*Click here to view the the dataset used for this manuscript. (The first worksheet in this Excel file contains the description and data dictionary; the second worksheet contains the data for the 13,327 studies and all of the variables used in the analysis.)