A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants can make informed decisions about enrolling in clinical trials can make informed decisions about potential trial participation and know how their participation may have helped others. Clinicians benefit by knowing about trials in which their patients might participate, having a more complete evidence base for decision-making, and seeing potential new treatments as they emerge. And for you, the research community, you can take timely information about clinical trial findings, be they positive or negative, to guide future research toward the next great innovation in health. We believe strongly that we have an obligation to share clinical trial information widely and in a way that both protects participant privacy and accelerates scientific discovery. Thus we are taking important steps to advance the sharing of clinical trial results. Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. This Notice of Proposed Rule Making (NPRM) further clarifies clinical researchers’ requirements under FDAAA for clinical trials that meet the legal definition of an “applicable clinical trial,” incl...
Source: NIH Extramural Nexus - Category: Research Authors: Tags: Rock Talk Clinical Trials Grants policy Source Type: funding