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New Study May Alleviate Sponsor, Regulator Concerns About Foreign Trials


Drugmakers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in more research savvy, developed nations, a new study concludes.

No statistically significant difference in data quality was revealed when comparing clinical trial data from such developing regions as India, Eastern Europe, Latin America, Africa and China with data from North America and Western Europe, the study in the July 10 Drug Information Journal found. The journal is published by the Drug Information Association.

International trials have taken off in the past two decades, according to the study, necessitated in part by low participation rates in developed areas like the U.S., Western Europe and Japan. Also feeding the trend is companies’ desire to market products globally and to study diseases that are prevalent only in certain regions.

While globalization of trials has helped drugmakers maximize returns on R&D investments, socioeconomic, medical and educational disparities in emerging nations have fueled concerns about the quality of data generated there.

Other objective measures of foreign trials should be studies as well, including adverse events reporting, the authors say. Reporting can be an issue for both foreign trials and those conducted here in the U.S. Are your adverse event reports up to code?

When it comes to labeling unexpected events during a clinical trial, most investigators agree: The answer isn’t always obvious. The definitions — and the required responses — vary from one agency to the next.

FDAnews’ Clinical Trials Adverse Event Reporting Reference Guide, Second Edition provides official OHRP and FDA answers to nagging questions your site might have.

Whether you’re in drugs or devices — a CRO or a clinical trial site operator — this guide belongs on your bookshelf. When those tough calls arise, you’ll find yourself referring to it again and again. Order today!