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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On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and institutional review boards (IRB) define, identify, and report protocol deviations.
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The Health Research Authority (HRA) announced that England and Wales have begun implementing changes to their clinical trial regulations on June 1st, 2024. These changes include the removal of the requirement for trials to submit annual progress report to their Research Ethics Committee (REC) and the process of submitting safety reports. Scotland and Northern Ireland, following review, also implemented these changes to their regulations making the updates now applicable in all four of the UK nations as of August 1st, 2024.
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The World Health Organization (WHO) issued a draft guidance for best practices for clinical trials in July 2023. It outlines key scientific and ethical considerations for “good controlled” (also known as well-controlled) trials, guidance on strengthening the clinical trial ecosystem, and addressing underrepresented populations.
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Posting Applicable Clinical Trials and expanded access on ClinicalTrials.gov was first required in the Food and Drug Administration Amendments Act of 2007 (FDAAA). The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands on the regulatory requirements and procedures for submitting registration and results posting to ClinicalTrials.gov.
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In June 2023, the U.S. Food and Drug Administration (FDA) issued a permanent debarment as required under the FD&C Act due to the grounds that the individual was convicted of a felony. The individual worked as a coordinator at a clinical site on studies over a variety of therapeutic areas. Their delegated tasks included administering procedures and maintaining case histories of the study participants.
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The US Food and Drug Administration issued a draft guidance on “Psychedelic Drugs: Considerations for Clinical Investigations” in June 2023. Psychedelics are a new horizon development potential in clinical trials. As more sponsors and sponsor-investigators move towards psychedelic drug development as a new psychiatric therapy, questions arise about the best way to move forward within the regulatory framework for clinical trials.
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The U.S. Food and Drug Administration (FDA) announced that the ICH E6(R3) Good Clinical Practice draft guidance is available for comments. This draft includes the GCP Principles and Annex 1, and the ICH Working Group is updating Annex 2.
