05/10/2022

In a US Food and Drug Administration (FDA) investigator warning letter, an investigator was cited for enrolling study participants in more than one clinical trial, although they should have been excluded per the exclusion criteria in the applicable protocols. The justification given for the decision to enroll was that the applicable study participants have ultra rare diseases and that consultation with the medical monitor at the sponsor occurred to clarify the exclusion criteria. However, there was no documentation of this conversation, and a subsequent medical monitor requested the applicable study participants be withdrawn from one of the trials. This also indicates that they should not have been dually enrolled initially.

An interesting note about the initial medical monitor’s statement was that they felt that it did not meet exclusion criteria because the investigational product was only used for emergencies. A frequent misunderstanding in novice clinical research medical personnel occurs between standard of care treatment best practices and protocol specific good clinical practice. If a medical practitioner is functioning as a clinical trial professional, they must follow the inclusion/exclusion criteria per the protocol even if medically the choice would be sound. The protocol is designed to answer a scientific question about the investigational product while protecting the study participants. It becomes difficult to determine which IP is causing the effect or safety issue if more than one is used. Even if the same IP is used in both cases, it would be difficult to determine which protocol’s study procedures were responsible for the outcome. If inclusion/exclusion criteria are not followed, this potentially leads to jeopardizing study results and study participant safety. From a regulatory perspective, the data from such a trial is likely to be seen as not reliable to support an application.

- The Clinical Pathways Team

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