Jennifer Miller comments on new rules for drug trial transparency
In a Wall Street Journal Article, Jennifer Miller, a George C. Lamb, Jr. Regulatory Fellow with the Kenan Institute for Ethics, discusses new rules set by the U.S. Department of Health and Human Services regulating clinical drug trials. The rules come in response to findings that a large number of clinical trials do not publish their data to the organization. There are concerns, however, on the organization’s willingness to punish those who do not follow the new guidelines.
“There’s reason for concern,” because the government did not add enforcement and monitoring capability to the existing law, says Jennifer Miller, who is a fellow at the Kenan Institute for Ethics at Duke University. She is working on a study about compliance in reporting trial results and says preliminary findings indicate oversight and enforcement by the FDA of existing regulations is weak.