5/05/2021
Photo by Hiroshi Kimura on Unsplash
Background
In clinical studies, The Food and Drug Administration (FDA) “works to protect participants in clinical research and ensures that subjects have reliable information before deciding whether to join a clinical trial.” When it comes to children participating in research, there are ethical concerns. These concerns are mainly due to their vulnerability related to their inability to understand the protocol requirements, adequately providing assent, and their legal representative’s consent. It is imperative that the clinical investigator conducts the study in accordance with the investigational plan (protocol) for the safety of these and other subjects involved and for the accuracy of the data it creates. The protocol for a trial is the road map of the study that describes how the trial will be conducted.
New Warning Letter Issued
A warning letter was issued to Dr. Evelyn Lopez-Brignomi, M.D. this March in regards to “objectionable conditions observed during an FDA inspection conducted at her clinical site between June 8 and June 23, 2020.” This study contained pediatric subjects who are a vulnerable population which raises concern about the severity of the violation and their potential impact on subjects’ rights, safety, and welfare. The warning letter states that “Dr. Lopez-Brignomi failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60]. As a result, the pediatric subjects may have taken either placebo only rather than the required study drug, or less than the full intended dose of study drug. In response, as a corrective action to the violations, Dr. Lopez-Brignomi directed her site to require all staff correspondence with the sponsor to be either in writing or via email, including any protocol-related questions. Regular training of site and staff on standard operating procedures (SOP) have been implemented at this site as well as a training session on investigational product dosing and compliance among other corrective actions. The FDA acknowledges these changes and noted that they failed to include specification of the corrective actions that Dr. Lopez-Brignomi will take to prevent similar violations in the future.
Why this is Important
Researchers are required to follow strict rules to ensure participant safety. Such a violation can put subjects in harm's way as well as raise concerns about the validity and integrity of the data collected within the study. Being that this violation involves pediatric subjects who are a vulnerable population, the severity is heightened due to the potential impact of children’s rights, safety, and welfare. The Code of Regulations, 45 CFR 46, outlines specific requirements to enhance protections for groups that are considered vulnerable populations within clinical research.
You can purchase access for your team to our educational recorded webinar on Special Considerations in Pediatric Trials Here.
-The Clinical Pathways Team
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