Get Your Study Enrolled - Designing Your Impairment Protocol to Prevent Challenges, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn how renal impairment study protocols can be improved to maximize patient enrollment. Attendees will understand design considerations around mild, moderate and/or severe populations, and the resulting implications for recruitment. The featured speakers will challenge thinking on what a "typical" patient looks like — from glomerular filtration rate (GFR) estimates to cholecystectomies — and how to avoid assumptions that inadvertently limit patient populations. Attendees will gain insights on how to avoid mistakes in protocol inclusion and exclusion criteria. The speakers will share their collective experience of what regulators are looking for when conducting impairment studies. The speakers will also reflect on some of the key points in the FDA Draft Guidance "Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing."
TORONTO, April 22, 2024 /PRNewswire-PRWeb/ -- As drug development progresses, regulators require clarity on how products are metabolized in the human body, and the risks associated with compounds that may linger in critical organs.
Renal impairment studies are a challenging area to recruit, especially for moderate and severe subjects. Therefore, making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
This webinar will draw on experiences from both the site and clinical research organization (CRO) perspectives to inform sponsors about how protocols might be written better to maximize patient enrollment opportunities, thus balancing the practicalities of achieving study goals while also satisfying the needs of regulatory bodies around the world.
The webinar will discuss observations from the presenters' collective history of working with regulators and help guide design decision-making to successfully enroll patients and keep drug development on track.
Register for this webinar to understand how impairment study protocols can be improved to maximize patient enrollment.
Join Barbara Gillespie, MD, MMS, FASN, VP and Therapeutic Head of Nephrology, Fortrea; Adjunct Professor, Division of Nephrology and Hypertension, University of North Carolina School of Medicine; Jasmine Ropers, Associate Director of Project Management, Fortrea Clinical Pharmacology Services; Stephen Flach, MD, PhD, Executive Medical Director, Clinical Pharmacology, Fortrea; and Thomas C. Marbury, MD, President, Orlando Clinical Research Center, for the live webinar on Thursday, May 9, 2024, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Get Your Study Enrolled – Designing Your Impairment Protocol to Prevent Challenges.
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