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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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.
In this culture of “just get it done”, have you ever thought if there was a better way? Have you heard others in the workplace say these things or thought them yourself?
“There is so much work to get done. If I spend time worrying about how to do things differently, I will be here all day!”
Topic: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11
Date: February 14, 2019
Time: 1:00 p.m. – 2:30 p.m. EST
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
The Food and Drug Administration (FDA) has revised the draft guidance, “Rare Diseases: Common Issues in Drug Development Guidance for Industry”. The original draft guidance was issued August 2015. The revised draft guidance is offered as an advance notice and will be published in the Federal Register at a later date.
The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register November 15, 2018 entitled, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act). Our previous blog details the proposed rule.
Do you understand the difference between consent and centricity? Perhaps you already know that patient centricity is the process where the patient has control over information and are free to make choices they are comfortable with. Learn from subject matter experts about challenges to integrating patient centricity into clinical trials and how eConsent supports subject comprehension and decision making. Our own Sandra “SAM” Sather and an expert panel present information to help you support patient centricity with eConsent.