Going Virtual: Evolving Real World Evidence Study Design For Speed, Flexibility, & Lower Cost
Sponsored by: Covance Market Access
Date: 19 September
Time: 4PM London/11AM EST
Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites. We present the elements required to conduct prospective virtual RWE studies, including online patient recruitment, e-consent, patient-centric call center support, physician oversight, online questionnaires, and local lab testing. We also cover the elements needed to conduct retrospective virtual RWE studies using electronic data that can replace the need for an expensive prospective study. Both of these models show great promise in lowering the cost and improving the efficacy of current, site-based RWE studies.
John D. McDermott Jr, MBA,
VP, Covance Market Access
John McDermott is a vice president at Covance Market Access Services whose interests include product differentiation, molecule valuation, reimbursement planning, marketing strategy development, and public policy analysis for the drug and medical device industries. In his 24 years as a consultant, he has focused on value proposition development, burden of illness and health economic studies, Medicare and managed-care payment strategies, new-product launch planning, and payer and provider market research for cardiology, gastroenterology, hematology, neurology, oncology, and urology drugs and devices.
Before joining Covance, Mr. McDermott spent two years at Hill-Rom, the world’s largest maker of hospital beds and therapeutic support surfaces, as manager of strategic planning and new business development. He gained valuable exposure to academic medicine as an intern for three years in the Dean's Office at Dartmouth Medical School. He also spent a summer as a pension fund analyst at Shearson Lehman Hutton and as a marketing intern at Amgen.
Mr. McDermott received his A.B. from Dartmouth College with honors in English and a modified major in Native American Studies. He received his M.B.A with a concentration in health services management from the Fuqua School of Business at Duke University.
Stephen O. Crawford, PhD, MHS,
Director, Global HEOR, Covance Market Access
Dr. Crawford is an epidemiologist with over 15 years of academic and industry experience in patient-centric real world data collection, observational study design, the development, validation and implementation of clinical outcome assessments (COA) in global clinical trials, and the evaluation of real world data, including claims and electronic medical records. Dr. Crawford leads several ground break virtual biomarker studies which enroll subjects online via eConsent, collect COAs electronically, and collect clinical laboratory samples nationally at LabCorp labs located near each subjects’ home. He also leads the PRO strategy, eDiary validation, and eCOA implementation efforts for two large global trial programs in urinary incontinence and type 1 diabetes. Dr. Crawford also led a study to assess the psychometric reliability and validity of a cognitive test battery among elderly European subjects at risk of developing Alzheimer’s disease in three European countries.
Prior to joining Covance in 2012, Dr. Crawford oversaw a team of epidemiologists and biostatisticians at a major health services company, leading an evaluation of integrated disease management services across business units and supporting an assessment of an integrated care and disease management pilot program for end-stage renal disease patients. He also has experience in a payer organization. Dr. Crawford earned a PhD and MHS in Epidemiology from the Johns Hopkins Bloomberg School of Public Health and a BA in Biochemistry and Music from Bowdoin College.
Peter M. Wahl, ScD, MLA, MS,
Pharmacoepidemiologist, Covance Market Access
Peter Wahl, ScD, MLA, MS is a pharmacoepidemiologist specializing in complex pharmacoepidemiologic study design and analytic methods in the conduct of both prospective and retrospective observational studies. Dr. Wahl has extensive experience in the strategic development of real-world evidence (RWE), with expertise in the full spectrum of primary and secondary health care data, including electronic medical records, administrative claims, administrative hospital system databases, and other electronic healthcare records. His responsibilities at Covance include identifying and working with strategic partners to facilitate virtual RWE, providing input on processes to integrate plug-and-play components into virtual RWE systems, directing pharmacoepidemiological study design and advanced analytics, and devising strategic advice for clients in the development and synthesis of real world evidence across all phases of product development. Most recently, he is serving as co-lead for a LabCorp/Covance initiative to develop a large registry that integrates genetic and real-world data to support drug discovery and development.
Prior to joining Covance, Dr. Wahl held management, consulting, and research positions in for-profit and academic institutions including Aetion, the Division of Pharmacoepidemiology & Pharmacoeconomics in the Department of Medicine at the Brigham & Women’s Hospital and Harvard Medical School, HealthCore, the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine, CareScience, the University of Pennsylvania Institute on Aging, and the Division of Cardiothoracic Surgery at the Hospital of the University of Pennsylvania.
Dr. Wahl received his ScD in Epidemiology from the Harvard School of Public Health (with a primary major in pharmacoepidemiology and a secondary major in cardiovascular epidemiology), his MS from the University of Pennsylvania School of Medicine under an NIH cancer research training fellowship, and his MLA from the University of Pennsylvania. He received his training in Pharmacoepidemiology in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital and Harvard Medical School, with special interest in comparative effectiveness and safety research using linked EHR and administrative claims data. Dr. Wahl also holds a BA in Economics from Cornell University.
Key Learning Objectives
- Understand the implications of electronic informed consent by the FDA
- Understand the elements of conducting a prospective virtual RWE study
- Understand the elements of conducting a retrospective virtual RWE study
- Heads of HEOR
- Heads of Medical Affairs
- Heads of Real World Evidence
- Heads of Evidence Generation
- Heads of Outcomes Research
- Heads of Data