The Role of Clinical Endpoint Committees in Medical Device Trials

Developers of medical devices face the challenge of defining efficacy and safety endpoints that are scientifically measurable, objective, and valid. Clinical trials are often driven by clinical events that may lack standard definitions or are subject to interpretation. In these scenarios, sponsors need a reliable method for reducing the impact of variability on conclusions drawn from analyses of outcomes data.

Independent endpoint assessment and adjudication committees, otherwise known as clinical endpoint committees (CEC), can play a significant role in reviewing and classifying suspected efficacy and/or safety endpoints to provide standardized endpoint outcomes for statistical analysis. This centralized adjudication process enhances the quality, validity, and integrity of study results, which can improve the likelihood of clinical trial success.

This webinar will discuss the value of clinical endpoint committees in medical device evaluation programs and explore the process of organizing, managing, and implementing a centralized adjudication process for standardizing study endpoints.

CEC-adjudicated endpoints may be used in critical decision-making processes including power estimations, periodic safety reviews by data monitoring committees or data safety and monitoring boards, sample size re-estimation and other interim analyses, and overall efficacy and safety analyses. Consequently, CEC-adjudicated outcomes need to be finalized and made available on an ongoing basis throughout the lifespan of a trial. By enabling more timely identification of efficacy signals or safety risks, central adjudication may facilitate go/no-go decisions and potentially reduce trial costs. Clinical endpoint committees, therefore, play an integral role in adaptive trial designs.

Sponsors who are considering use of a clinical endpoint committee should keep the following in mind to support successful central adjudication:

• The study protocol should include a well-defined data capture strategy that addresses handling of suspected endpoint and adjudicated outcome data, which should be defined in a clinical endpoint committee charter
• The study protocol should include a clearly delineated tactical plan for effective endpoint case management
• The clinical endpoint committees adjudication workflow must be structured to deliver consistent, reliable, and accurate results

Among the questions the speaker will address, are:

• What methods should be considered to support accurate detection and reporting of all potential suspected endpoints?
• How will the suspected endpoint and adjudicated outcome data be handled within the overall study data-capture plan?
• What methods will be used to ensure that final adjudicated outcomes are complete and current?

Speakers

Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research

Joanne Emmett has been part of the clinical research industry for 20+ years with a keen focus on operational design and delivery. Ms. Emmett started her career in academia within transplant research and proceeded on to cardiovascular research involving valve and imaging trials. Once joining the CRO business space in 1995, she was engaged as a CRA, LCRA and Project Manager working on trials in CNS, Oncology, Respiratory, Cardiovascular Device and several diagnostic programs. Ms. Emmett took her front-line delivery experience to the next level and moved into oversight and department leadership specializing in Clinical and Project Management Delivery, spending time at PRA and joining Premier Research in early 2011.

Since then, Ms. Emmett, has been responsible for the operational delivery structures and planning for both clinical and project management. She has focused on the key needs and standards within therapeutic and medical device and ensuring core process designations for staffing and oversight, including the unique regulatory and scientific avenues required for medical device.

Ms. Emmett has been engaged over her career with ACRP, chairing the Poster Committee in 2006 and moving onto Chair the Annual ACRP meeting in 2007. She also spent time with development and implementation of the Post Graduate Clinical Research Program at Humber College in Toronto. Ms. Emmett has her PMP designation, Management and Business Administration Certificate from the American Management and Business Administration Institute, CCRA from ACRP, Post Graduate Clinical Research Certification and BSc from the University of Western Ontario in London, Canada.

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Janet Kube, Director, Project Management, Premier Research

Janet Kube oversees Premier Research’s project managers and directors, supporting global collaboration, monitoring activity and metrics reporting, and acting as senior customer liaison to ensure adherence to time, cost, and quality performance targets.

Mrs. Kube has more than 20 years of experience in clinical drug development and medical device licensing in the CRO field, operating in Western, Central, and Eastern Europe; the United States; Australia; and New Zealand. After spending several years as a clinical research associate, she managed complex oncology and central nervous system studies before moving into the medical device field, where she currently specializes and has overall responsibility for trials and customers in the cardiovascular field.

Before joining the drug development industry, Mrs. Kube worked as a registered pediatric nurse and an operating room nurse, focusing on orthopedic, emergency, and plastic surgery. She is a former member of Interplast, an international organization of plastic surgeons. In this role, she traveled to developing countries to perform reconstructive surgeries.

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