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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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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.
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In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems.
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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global clinical development programs (CDP) for new cancer treatments. The guidance provides advice on using evidence obtained from multi-regional clinical trials (MRCT) to support marketing applications.
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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits
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The US Food and Drug Administration (FDA) recently updated their website to include a Frequently Asked Questions page for their Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program was announced in October 2022 and is intended to support new labeling claims, a new indication for an approved drug, or to satisfy post approval requirements.
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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.
