Poor patient safety, record keeping common violations in clinical trials
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.
“All research stakeholders have a fundamental responsibility to conduct ethical clinical trials following the principles of good clinical practice,” researchers wrote in theJournal of Medical Ethics.
The researchers 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, and 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 of 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 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.
Disclosure: The researchers report no relevant financial disclosures.
