Enhanced data reporting, increased globalization among recent trends in clinical trial research
THURSDAY, Feb. 19 (HealthDay News) -- All clinical trial data and the U.S. Food and Drug Administration database should be publicly available, and global clinical research should be conducted in relevant populations for potential applications of the intervention, according to two articles published in the Feb. 19 issue of the New England Journal of Medicine.
In the first article, Alastair J.J. Wood, M.D., of Weill Medical College of Cornell University in New York City, discusses recent progress made in legislation to expand requirements for reporting clinical trial registration and results. He also proposes additional legislation to augment this, including access to all FDA reviews following product approval, all available clinical trial results after one year of study completion or inactivity, and all safety data within two years of trial completion. Improved use of data and public database access will lead to "more accurate systematic reviews, better clinical decision making, improved patient care, and improved research efficiency and safety," Wood writes.
Seth W. Glickman, M.D., of the Duke University School of Medicine in Durham, N.C., and colleagues reviewed recent trends in the globalization of clinical research, including data showing a doubling of the number of countries involved in clinical trials over the past 10 years. Reasons cited for globalization included cost savings, a shortened timeline and decreased bureaucracy. Proposals to enhance clinical research globalization include streamlining government regulations, improved international collaboration and transparency in study results.
"We must ensure the ethical and scientific integrity of clinical research globally, promote harmonization of international research, and provide information about the benefits and risks of new drugs and devices in the populations and environments in which patients live, wherever they may be," Glickman and colleagues conclude.
Abstract - Wood
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Abstract - Glickman
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