In the Journals

Poor patient safety, record keeping common violations in clinical trials

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June 25, 2014

Failure to protect patient safety and maintain documentation were among the most common violations US regulators cited in warning letters regarding the conduct of clinical trials, according to new data published in the Journal of Medical Ethics.

“All stakeholders should take responsibility and conduct research ethically,” study researcher Aafreen Saiyed, BASM, of Seth GS Medical College, King Edward Memorial Hospital, Mumbai, told Infectious Disease News. “At the same time, regulators globally should regularly inspect study sites.”

Saiyed and Yashashri Shetty, MD, reviewed 84 warning letters issued by the FDA to clinical investigators, sponsors and institutional review boards (IRBs) between 2005 and 2012 to identify certain themes in violations. Warning letters provide an opportunity for an individual or group responsible for the clinical trial to take corrective steps before the FDA takes regulatory action.

The most common violations cited in warning letters to clinical investigators were the deviation from the stated plan of the investigation (95%) and failure to protect the safety of clinical trial participants and report adverse events to the IRB (55%). Most of these violations (80%) concerned investigational drug studies, whereas the rest were related to devices. Poor record keeping also was a common violation (40%).

For clinical trial sponsors, the most frequent violation was a failure to monitor progress of the trial (58.7%), followed by a failure to obtain an agreement from the principal investigator (34.8%). Almost one-quarter (23.9%) of these violations were related to new drug studies.

Finally, the most common reasons for issuing a warning letter to IRBs included failures to follow standard operating procedures (61.1%) and to maintain proper documentation (55.6%). Again, a majority of the research (66.7%) was drug-related.

The researchers compared their findings with previously published research dating back to 1997, discovering that regulatory compliance has generally improved over the years, but study supervision has worsened. Two new crucial violations have emerged: failure to obtain IRB approval before initiating the study and submitting false data to the FDA and trial sponsors.

To curb the frequency of these violations and re-establish public trust, the researchers suggest that regulators conduct site visits on a consistent basis to ensure compliance.

“Fair and appropriate procedures for handling violations during clinical trials need to be developed and implemented globally in order to protect human rights, well-being and safety, and to raise awareness of ethical behavior,” they wrote. — John Schoen

Yashashri Shetty, MD, can be reached at: department of pharmacology and therapeutics, Seth GS Medical College, KEM Hospital, Parel, Mumbai; email: aafrinsaiyed@yahoo.co.in.

Disclosure: The researchers report no relevant financial disclosures.