Journal Article

The Proposed Rule for U.S. Clinical Trial Registration and Results Submission

Tse, Tony, Sheehan, Jerry, Zarin, Deborah A

2015

Overview

This article calls attention to an open public comment period regarding a proposed new rule from the Department of Health and Human Services that affects clinical trial registration and results reporting. Broad access to information about clinical trials and their findings is critical for advancing medicine, promoting public health, and fulfilling ethical obligations to human volunteers. 1 Traditional methods of information dissemination (e.g., presentations and publication) may nevertheless leave distortions and gaps in the knowledge base because the results of many trials are not published. 2 – 4 Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) 5 addressed some of these concerns by requiring the registration and submission of summary results information to ClinicalTrials.gov for certain clinical trials of drugs (including biologic products) and devices. The Department of Health . . .

• Publisher: Massachusetts Medical Society
• Subject: Clinical trials / Clinical Trials as Topic - legislation & jurisprudence / Clinical Trials as Topic - standards / Databases, Factual / Device Approval - legislation & jurisprudence / Device Approval - standards / Drug Approval - legislation & jurisprudence / FDA approval / Feasibility studies / Government Regulation / Medical equipment / National Institutes of Health (U.S.) / Pharmaceutical industry / Registration / Registries / United States / United States Food and Drug Administration