3/30/2021
Photo by Giulia May on Unsplash
What happens when an investigator or a sponsor of a clinical trial does not comply with FDA Code of Federal Regulations? And when they do not comply what needs to be done? Inadequate responses to inspection findings are very negatively impacting. Have you wondered how they are notified they are doing something wrong?
Background
The United States Food and Drug Administration (FDA) requires entities conducting clinical trials to go through steps for approval prior to beginning the trial. They also require adherence to several regulations. When these obligations are not met, it can be detrimental to study subjects, the public, and the integrity and quality of the data. The FDA sends warning letters to clinical research sponsors, investigators, and other organizations outlining the errors that were made so they can take appropriate action. (About Warning and Close-Out Letters | FDA)
New FDA Warning Letter Issued in COVID Drug Trial
As the severity and impact of the coronavirus increased in the United States from early 2020, many drug sponsors began to conduct trials of drug treatments for the virus. Several of these trials were not being conducted properly and lacked adherence to FDA guidelines or even approval of the trial. Over two thousand warning letters regarding COVID-19 treatments were sent out from early March 2020 to present.
An example of this occurrence is the warning letter recently issued to KDunn and Associates, P.A. doing business as HealthQuilt on February 16, 2021. KDunn and Associates, P.A. dba HealthQuilt - 611864 - 02/16/2021 | FDA. The warning letter pointed out several serious findings including:
Failure to submit an Investigational New Drug application for approval to conduct a clinical trial as the study drug was categorized by the FDA as a drug and not a dietary supplement as was purported by HealthQuilt (this is a common occurrence when sponsor-investigators forget to follow the required protocol as sponsors but comply with the investigator responsibilities)
Failure to maintain records of the shipment, storage, receipt, or accountability logs for the study drug
Failure to properly obtain informed consent as the informed consent form contained exculpatory language which waived any right to the applicable parties involved in the study responsible for any injury, damage, etc.
Failure to maintain and retain case report records and documents including informed consent forms for at least two years after the end of the study
The warning letter was sent to HealthQuilt due to the Corrective and Preventative Action Plan (CAPA) being insufficient to address the FDA’s concerns. CAPA’s should be comprehensive and provide all details on how each issue will specifically be resolved. HealthQuilt’s CAPA also did not detail on if the exculpatory language was removed from the informed consent documents. Per FDA Code of Federal Regulations 50, no informed consent document can include exculpatory /hold harmless verbiage.
CAPA is a dynamic process that requires training and development. Does your research staff need training on CAPA development or Investigator Initiated Trials? Clinical Pathways provides an eLearning “Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals”. Contact us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
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