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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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s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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Decentralized clinical trials (DCTs) have increased in popularity during the pandemic. The US Food and Drug Administration (FDA) released guidance on Conduct of Clinical Trails of Medical Products During the COVID-19 Public Health Emergency that clarified that decentralization of clinical trials through remote collection of data outside of a physical location is permissible as long as methods follow regulatory requirements.
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Recently, a community hospital Institutional Review Board (IRB) received a US Food and Drug Administration (FDA) warning letter for lack of appropriate members present to review research, inadequate documentation, and inadequate informed consent review.
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On February 16, 2023, the European Parliament voted to adopt the European Commission’ proposal to extend the MDR transition period and to extend some device certificates.
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The European Medicines Agency (EMA) Good Manufacturing Practice Frequently Asked Questions (FAQ) webpage offers guidance on good manufacturing practice (GMP) and good distribution practice (GDP). Previous revisions in February and October 2022 were relating to veterinary medicinal products.
