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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.
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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.
Time: 12-1 pm
To Sign-up: Link to ACRP eConsent Webinar
Registration Deadline: February 27, 2017
Description:
In this webinar Sandra “SAM” Sather, VP, Clinical Pathways, Regulatory & Quality lead for eConsent, CRF Health Trial Consent and Michael Conde, is the Senior Director of Technical Solutions at CRF Health discuss how eConsent (eIC) improves investigator, sponsor and IRB oversight for informed consent and decreases risks.
Part 2 of this series summarized the background and need for the upcoming updates to ICH E6 and ICH E8 per the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 27th. Section 2 of the reflection paper “Proposed Structure for a Modernized ICH E8 Guideline and a Future Renovated ICH E6 Guideline” focuses on ICH E8 explaining the need for modernization.
Part 1 of this series summarized the purpose and intention for the upcoming updates to ICH E6 and ICH E8 per the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 11th. The background section first evaluates the current state of ICH E6 and explains the need for renovation.
Date: February 23, 2017
Live Webinar Time: 3 pm London / 10 am New YorkDuration: 60 Minutes - Online
Description:
The new reality of our industry reveals the need for implementing further initiatives to improve trial oversight and enable a better experience for all stakeholders.
The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.
