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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.
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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
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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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Master protocols can increase efficiency of clinical trials while reducing risks to subjects. A master protocol compares multiple different investigational products with one placebo within one protocol. An adaptive design may be built into the protocol so that a substudy could be eliminated if the data warrants. Read our blog on adaptive design for further information.
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Metrics Champion Consortium (MCC) launched the work group last October as an opportunity for MCC member organizations to discuss how risk-based quality management is transforming process metrics for monitoring. The work group is considering the impacts that centralized, targeted, and remote monitoring have on process metrics, which have traditionally been based on onsite monitoring.
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There have been many questions about how to monitor clinical trials amid the changing landscape of COVID-19 restrictions. Remote monitoring is one of the ways of reducing onsite monitoring visits at a time of physical distancing and travel restrictions. Metrics Champion Consortium (MCC) launched the MCC COVID-19 Knowledge Sharing Group as an opportunity for MCC member organizations to share knowledge and to support one another during this uncertain time.
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Our popular “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” webinar prompted many important questions, which we answered during the webinars. If you missed the webinar, a recording is now available for purchase. We also compiled a FAQ document to help guide your remote monitoring efforts during the crisis.
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Clinical Trial Transformation Initiative (CTTI) collected information from clinical trials stakeholders in March during increasing COVID-19 restrictions. An ongoing concern is how to balance keeping subjects, sites, and monitors safe while deciding whether and how to continue clinical trials or if they should be placed on hold.
