Pharmaceutical

Clinical trial safety protocol overlooked, FDA says

research test tubes Clinical trial safety protocol overlooked, FDA saysThe Food and Drug Administration (FDA) issued a warning letter to Dr. Laveeza Bhatti with Beverly Hills’ Cedars-Sinai Medical Group for disregarding safety protocols regarding cardiovascular safety during clinical trials of experimental drugs, Law360 reports.

The name of the drugs were redacted in the letter published online, but the letter indicated that the drugs carried potential cardiovascular risks. Thus, the study’s protocol called for participants to have electrocardiograms (ECG) performed during the testing and for the drugs to be discontinued if certain heart problems were diagnosed. However, at least five patients in the study missed some of the ECGs.

“Failure to diagnose in a timely manner places subjects at risk of developing .. . a potentially fatal arrhythmia. Therefore, missing protocol-required ECGs compromises subject safety,” the warning letter stated.

The agency also called out the doctor for allowing several patients to enter the study who were not eligible based on the study’s criteria, and for not retaining study records as required by FDA regulations, which the agency says “jeopardizes subject safety and welfare and compromises the validity and integrity of the data collected at your site.”

Dr. Bhatti was given 15 working days to respond to the warning letter in writing with the actions taken to prevent similar violations in the future. Failure to address the violations noted in the warning letter may result in regulatory action without further notice.

Sources:
FDA Warning Letter