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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
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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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The ICH Q9(R1) international guideline on Quality Risk Management reached step 4 on January 18, 2023. Step 4 is when the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory Members of the ICH Assembly have adopted the guideline as a harmonized guideline.
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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released draft ICH E6(R3) Principles. ICH E6 Good Clinical Practice (GCP) guideline is the blueprint for clinical trials ensuring subject safety and data quality and it specifies the processes needed for study conduct and documentation to comply with the guideline and regulatory requirements. The last revision occurred in 2016. Since then, clinical trials are increasingly complex and in electronic formats, requiring updates to the GCP guideline to ensure its agility to meet the challenges of modern clinical trials.
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Clinical trials have become increasingly complex since the ICH E8 guideline on “General Considerations for Clinical Trials” was finalized in 1997. The draft revision is in Step 2b and available for public comment, and there are some interesting changes to note. Specifically, there is a greater emphasis on patient centricity, design of trials with quality in mind, and risk management. The overlying theme is fit-for-purpose quality as an essential consideration for study design. The revision is part of the Good Clinical Practice (GCP) Renovation initiative. Previously, the ICH E6 GCP R2 addendum was finalized in 2016.