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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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s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 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.
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The U.S. Food and Drug Administration (FDA) announced that the “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” draft guidance is available for comment. When finalized, the draft guidance fulfills the requirement for guidance on decentralized clinical trials under Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA).
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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline for ICH E6(R3) Good Clinical Practice, which reached step 2 on May 19, 2023 and is open for public consultation. This draft includes the GCP Principles and Annex 1, and updates to Annex 2 of the guideline are now underway.
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The US Food and Drug Administration (FDA) released a draft guidance “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers” in March 2023. When finalized, it will replace the 2007 guidance “FDA Computerized Systems Used in Clinical Investigations.” The FDA regulates electronic systems, electronic records, and electronic signatures used by sponsors and CROs to create records required for clinical trials per 21 CFR Part 11.
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The US Food and Drug Administration (FDA) released a final questions and answers guidance document, “A Risk-Based Approach to Monitoring of Clinical Investigations” in April 2023. It includes recommendations for developing a monitoring approach and the content of the monitoring plan, and follow up and communication of the monitoring results. The questions and answers guidance is a companion to the “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” guidance from August 2013.
