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Safety, Documentation Issues Common Clinical Trial Concerns

Culture of research needs to be safeguarded worldwide to ensure trial safety

MONDAY, June 30, 2014 (HealthDay News) -- Failure to protect patient safety and poor record keeping were among the most common violations picked up by the U.S. Food and Drug Administration in the running of clinical trials over a period of seven years, according to a study published online June 25 in the Journal of Medical Ethics.

Yashashri C. Shetty and Aafreen A. Saiyed, both from KEM Hospital in Mumbai, India, reviewed FDA warning letters issued to clinical investigators and institutional review boards (IRBs) from January 2011 to December 2012. Violation themes were identified. Using descriptive statistics, warning letters issued to sponsors from January 2005 through December 2012 were analyzed for a specific set of violations.

The researchers found that failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators. In warning letters to IRBs, failure to follow standard operating procedures and maintain documentation was seen as significant. New substantial violations in warning letters issued to IRBs included failure to maintain minutes of meetings and to follow written procedures for continuing review. In 46 sponsors' warning letters, the most common violations were failure to follow a monitoring schedule (58.69 percent), failure to obtain investigator agreement (34.78 percent), failure to secure investigators' compliance (30.43 percent), and failure to maintain data records and ship documents to investigators (30.43 percent).

"Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide," the authors write.

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