Get Your Study Enrolled – Designing Your Impairment Protocol to Prevent Challenges

Life Sciences, Clinical Trials, Patient Recruitment & Retention,
  • Thursday, May 09, 2024

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.


Barbara Gillespie, University of North Carolina School of Medicine

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

Dr. Barbara Gillespie, MD, MMS, FASN, is a board-certified Nephrologist who has been collaborating with sponsors on renal clinical development, protocol design and execution since 2006.  She is on the board of directors at the Kidney Health Initiative, a public-private partnership between the FDA and the American Society of Nephrology. She also serves on several advisory boards including the NKF Patient Network (CKD Registry) Steering Committee and various NephCure Steering Committees. Dr. Gillespie has served as an associate medical director at a small local dialysis unit until recently.  She completed her internal medicine residency at the University of North Carolina and nephrology Fellowship at Duke University.

Message Presenter

Jasmine Ropers, Associate Director of Project Management, Fortrea Clinical Pharmacology Services

Jasmine Ropers is Associate Director of Project Management and Strategy Lead for Phase 1 Renal and Hepatic Impairment Studies at Fortrea. She brings 24 years of clinical research experience, 7 years in data management and 16 years specializing in Phase 1 renal and hepatic impairment project management.

Message Presenter

Stephen Flach, MD, PhD, Executive Medical Director, Clinical Pharmacology, Fortrea

Dr. Stephen Flach, MD, PhD, is a board-certified Internist who has worked in Clinical Pharmacology since 2005 as a Principal Investigator, Medical Monitor and Consultant on a wide range of early-phase drug development projects. He has helped design and execute numerous renal and hepatic impairment studies since 2017. He is an Author on over 40 peer-reviewed publications. He was an Internal Medicine Resident on the Osler Medical Service at the Johns Hopkins Hospital and subsequently was a Fellow in General Internal Medicine at the University of Pennsylvania. Prior to working at Fortrea, Dr. Flach was on the faculty at the University of Iowa College of Medicine.

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Thomas C. Marbury,Orlando Clinical Research Center

Thomas C. Marbury, MD, President, Orlando Clinical Research Center

Dr. Thomas Marbury is board-certified in Internal Medicine and Nephrology and has served as Principal Investigator in over 1,000 Clinical Trials since 1978. He has published extensively in scientific and clinical journals and is regarded as a thought leader in the area of renal and hepatic trials. He has presented on various panels with other clinical pharmacology experts and FDA leaders at the industry’s national meetings. He is the Founder and President of Orlando Clinical Research Center since 1990. As the President of Orlando Clinical Research Center, his main areas of research are Phase I clinical trials.

Message Presenter

Who Should Attend?

This webinar will appeal to professionals involved in the commission and conduct of clinical drug development, working on products that impact either renal or hepatic systems.

What You Will Learn

Attendees will gain insights into:

  • Design considerations around mild, moderate and/or severe populations, and the resulting implications for recruitment
  • Challenge thinking on what a “typical” patient looks like. From glomerular filtration rate (GFR) estimates to cholecystectomies — how to avoid assumptions that inadvertently limit patient populations
  • Avoid mistakes in protocol inclusion and exclusion criteria
  • Learn from the presenters’ collective experience of what regulators are looking for when conducting impairment studies
  • 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”

Xtalks Partner


Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

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