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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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.
The Center for Biologics Evaluation and Research’s (CBER) Bioresearch Monitoring Program released a new investigator Warning Letter October, 2018. Interestingly, the category is listed as IRB. The investigator was involved with a clinical study of influenza vaccination in the pediatric population.
Background:
Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.
Join with subject matter experts and learn what really matters in clinical trial performance metrics in the first ever Metrics Champion Consortium (MCC) Summit. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis. Understand if your staff has adequate critical thinking skills to evaluate risk and take appropriate action. Identify effective performance management using Gilbert’s Behavioral Engineering Model (BEM) in Clinical Research. Discover answers to key questions while delving into case scenarios with speakers and other attendees during the interactive session.
Key Takeaways:
The Special 510(k) Program is an alternate pathway for premarket notifications.
It was originally established in 1998.
It allows manufacturers to declare that a modification to their own device cleared under 510(k) still conforms to design controls.
Currently, if a manufacturer modifies its own marketed device and changes the indication for use or creates technological differences, the application must be submitted as a traditional 510(k).