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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.
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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
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On June 26, 2024, the US Food and Drug Administration (FDA) released a new draft guidance “Diversity Action Plan to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” The underrepresented populations in clinical trials can be disaggregated by sex, age, and racial and ethnic demographics. If a subset of a population is not present during the clinical studies, potential differences in safety information may not be fully understood.
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There has been an increase in the complexity of clinical trials over the last decade. Add to that the support for including more diverse populations who may have additional underlying conditions (FDA Guidance document “Enhancing the Diversity of Clinical Trial Populations”), and this leads to an increase in the number of safety events reported.
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Diversity in clinical research is imperative to ensure the safety and effectiveness of drugs and medical devices for all people. Participants in clinical trials should reflect the consumers that will be using the medical product once it is approved. This is a concern because the product may react differently in different age groups, races, and ethnicities. The National Institutes of Health (NIH) confronted a lack of diversity in clinical trial participants in 1993 by supporting a policy requiring federally funded clinical research to include women and minorities called the NIH Revitalization Act of 1993. Clinical trials today still lack ethnic diversity, and the question remains as to how stakeholders can build equity into clinical trial design.
