2012 Webinar: Introduction to Adaptive Clinical Trial Designs

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Overview

Adaptive clinical trial designs (trials in which key trial components are modified during the conduct of the trial, and in response to information that accrues within the trial) have the potential to improve the efficiency and likelihood of success for clinical trials, in both exploratory and confirmatory settings. However, these approaches are not well understood, or have not yet been used by most clinical trialists.

As adaptive designs gain widespread popularity, it will be important for those who review protocols to be familiar with the general structure and features of adaptive designs. As the group tasked with protecting human subjects, IRBs will need to ensure that the features of a trial so designed are described adequately in the protocol. The purpose of this presentation is to provide an introduction to this method with conceptual principles, and to describe experience in the design andimplementation of adaptive clinical trials.  A case study of a trial in development will be presented to tangibly illustrate concepts and invite questions.

The following topics will be discussed during this presentation:

  • Definitions and terminology related to adaptive clinical trial design
  • Benefits of the adaptive approach in defining and addressing trial objectives
  • How to recognize the characteristics of adaptive design protocols and ensure that adaptive features of a trial are adequately described
  • The importance of providing a complete prior specification of potential adaptations and decision rules in the protocol and/or consent form
  • Distinctions between well-accepted and characterized methods (e.g., group sequential designs, blinded sample-size re-estimation) and more recently-developed or innovative methods (e.g., response-adaptive randomization, longitudinal modeling, identifying responsive patient subsets, seamless phase II/III designs)
  • Logistical and regulatory considerations related to adaptive clinical trials

Audience

This introductory webinar was of interest to HRPP professionals, including IRB chairs, members, and staff, and anyone involved in conducting or reviewing clinical trials.

Faculty

Roger Lewis, MD, PhD
Dr. Roger Lewis is a professor at the David Geffen School of Medicine at UCLA, and the vice chair for academic affairs in the department of emergency medicine at Harbor-UCLA Medical Center.  His expertise is in clinical research methodology, including adaptive and Bayesian trial design, and he participates in the design and analysis of numerous laboratory, clinical, and health services research studies.  Dr. Lewis serves as the chair of data and safety monitoring boards (DSMB) for both federally-funded and industry-sponsored clinical trials. Dr. Lewis is the senior medical scientist at Berry Consultants, LLC, a statistical consulting group that specializes in the design and implementation of adaptive clinical trials. He is a member of the board of directors for the Society for Clinical Trials and a past president of the Society for Academic Emergency Medicine (SAEM). In 2009, he was elected to membership in the Institute of Medicine (IOM) of the National Academies.

Dr. Lewis has served as a grant reviewer for the Agency for Healthcare Research and Quality (AHRQ), the Canadian Institutes of Health Research (CIHR), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Patient Centered Outcomes Research Institute (PCORI) and foundations.  He is a research methodology reviewer for JAMA and has served as a content reviewer for Academic Emergency Medicine, Annals of Emergency Medicine, Annals of Internal Medicine, Biometrics, Circulation, and Statistics in Medicine.  Dr. Lewis has authored or coauthored over 200 original research publications, reviews, editorials, and chapters.  He has served as a principal investigator or co-investigator on numerous research projects funded by a variety of federal, state, foundation, and commercial sources. Dr. Lewis received his PhD in biophysics in 1986 and his MD in 1987 from Stanford University.

William Meurer, MD, MS
Dr. William Meurer is an assistant professor of emergency medicine and neurology at the University of Michigan in Ann Arbor. His major clinical and research focus is on the early care of patients with acute neurological illness and injury, with an emphasis on stroke treatment. He serves as a site principal investigator on the CLEAR-ER acute stroke trial, and is a co-investigator on several acute stroke treatment trials. He works as a co-investigator for the clinical coordinating center for the Neurological Emergencies Treatment Trials (NETT) Network. In addition, he has an interest in the incorporation of flexible Bayesian adaptive clinical trial designs into confirmatory phase neurological emergency trial.

Dr. Meurer received his MD from the University of Cincinnati in 2003 and completed clinical training in emergency medicine in 2006 at the MetroHealth/Cleveland Clinic program in Cleveland, Ohio. He moved to the University of Michigan in 2006 and completed a fellowship in stroke and cerebrovascular disease. At Michigan he obtained his MS in clinical research design and statistical analysis from the School of Public Health in 2009. Dr. Meurer has authored or co-authored over 50 original research publications, reviews, and book chapters in the fields of emergency medicine, neurology and clinical trials.

Certificates of Attendance

Certificates of Attendance were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from this webinar toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.