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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.
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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.
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On September 21, 2023, the Food and Drug Administration (FDA) released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” to advise on formal meetings between the agency and sponsors or applicants involved in the development and review of investigational products. The new draft guidance replaces the previous version issued in December 2017.
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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.
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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
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The US Food and Drug Administration (FDA) offers a voluntary program that qualifies tools that sponsors may use in support of the development and evaluation of medical devices known as the Medical Device Development Tools (MDDT) program. Some examples of tools that may be included are electronic patient reported outcomes (ePRO) or wearables.
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The US Food and Drug Administration (FDA) published finalized guidance on “Informed Consent” August 2023. It finalized the “Informed Consent Information Sheet” which was previously in draft since July 2014 and supersedes the final guidance “A Guide to Informed Consent” from September 1998. It is applicable for IRBs, investigators, and sponsors.