Transparency, Globalization Growing in Clinical Research

Enhanced data reporting, increased globalization among recent trends in clinical trial research
By Lisa Cockrell, PhD
HealthDay Reporter

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
Full Text
Abstract - Glickman
Full Text

Copyright © 2009 ScoutNews, LLC. All rights reserved.

Powered by

jQuery UI Accordion - Default functionality

For life-long learning and continuing professional development, come to Lippincott's NursingCenter.

Nursing Jobs Plus
Featured Jobs
Recommended CE Articles

Debunking Three Rape Myths
Journal of Forensic Nursing, October/December 2014
Expires: 12/31/2016 CE:2.5 $24.95


Drug updates and approvals: 2014 in review
The Nurse Practitioner, 13December 2014
Expires: 12/31/2016 CE:3 $27.95


Can Food Processing Enhance Cancer Protection?
Nutrition Today, September/October 2014
Expires: 10/31/2016 CE:2 $21.95


More CE Articles

Subscribe to Recommended CE

Recommended Nursing Articles Evidence Based Practice Skin Care Network NursingCenter Quick Links What’s Trending Events