THE PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE appointed 10 members to a new Advisory Panel on Clinical Trials. The panel will convene for its first meeting May 1 in Washington, D.C.
Members of the panel will provide expertise on the design and implementation of randomized controlled trials.
Topics include selection of appropriate patient-centered outcomes, informed consent of study participants, periodic evaluations of the institute’s clinical trial portfolio, and the readiness of trial results for dissemination.
The panelists and four alternates were selected from 231 applicants. More than half are biostatisticians, epidemiologists, or others with technical expertise in conducting clinical trials. Two others represent patients, patient advocates, or family caregivers and another is an expert in the ethical aspects of such studies.
The 10 panelists are:
- Jason Connor, director and senior statistical sat Berry Consultants.
Connor is a biostatistician specializing in Bayesian and adaptive trial design. He currently holds academic appointments as a visiting professor at The Johns Hopkins University Bloomberg School of Public Health and assistant professor at the University of Central Florida College of Medicine. - Sanford Jeames, adjunct professor at Huston-Tillotson University and coordinator of Health Sciences Program, at Eastside Memorial High School.
Jeames is a community health educator and patient advocate. His interests include health education, cancer prevention, and healthier lifestyle interventions, with a focus on under-served populations. On behalf of NCI, he has served as a protocol reviewer with the Special Emphasis Panel and as a clinical trials reviewer for the Adult Central Institutional Review Board. - John Lantos, professor of pediatrics at Children’s Mercy Hospital
After 20 years on the faculty of The University of Chicago’s Pritzker School of Medicine, Lantos moved to Kansas City to create and direct a pediatric bioethics center at Children’s Mercy Hospital. His research focuses on the ethics of clinical trials and he has analyzed the ethical issues in neonatology, cancer chemotherapy, renal dialysis, cardiac assist devices, and primary care pediatrics. - Anne McTiernan, professor at Fred Hutchinson Cancer Research Center and the Schools of Public Health and Medicine at the University of Washington
McTiernan’s research focuses on disease prevention through weight control, physical activity, and chemoprevention. She has led multiple randomized controlled trials testing weight loss, exercise, medications, and supplements, and was the principal investigator of the NCI-funded Seattle Translational Research on Energetics and Cancer. - Margo Michaels, executive director and founder of the Education Network to Advance Cancer Clinical Trials.
Michaels has developed numerous programs to educate cancer advocates, community leaders, and healthcare professionals about policy and science issues related to cancer. Previously, she served as branch chief at the NCI’s Public and Survivor Education Branch; as the lead consultant to the Clinical Research: Affiliates Funding Trials program at the Susan G. Komen Breast Cancer Foundation; and as the director of the National Breast Cancer Coalition’s Project LEAD. - Craig Nichols, co-director of the Virginia Mason Medical Center Testicular Cancer Clinic and executive officer of Cancer Prevention and Control.
Nichols’s research focuses on rare malignant diseases and the development of clinical trials focused on cancer. He serves on the boards of several cancer non-profits and has extensive service with the NCI, national and international cancer research organizations, and cancer nonprofit organizations. - Frank Rockhold, senior vice president of Global Clinical Safety and Pharmacovigilance at GlaxoSmithKline.
Rockhold previously led the GSK Cardiovascular Development and Clinical Safety and Pharmacovigilance Departments. He has held leadership positions focusing on clinical trials, data standards, benefit to risk, clinical research, epidemiology, and most recently, pharmacovigilance. - Elizabeth Stuart, associate professor of mental health and biostatistics at The Johns Hopkins Bloomberg School of Public Health.
Stuart previously worked on a number of large-scale randomized trials of social interventions as a Researcher at Mathematica Policy Research. Her research interests include statistical issues associated with randomized trials, including handling complexities such as missing data, clustering, mediation analysis, and noncompliance. - Robert Temple, deputy center director for clinical science at the FDA Center for Drug Evaluation and Research
Temple began his career at FDA in 1972, serving as a reviewer in the endocrine and metabolic division. Since then, he has served as assistant to the center director, with responsibility for final sign-off on Drug Efficacy Study Implementation conclusions, as director of the Cardiorenal Division, as director of the Office of Drug Evaluation, and as director of the Office of Medical Policy. - Merrick Zwarenstein, director of the Centre for Studies in Family Medicine, Department of Family Medicine, Western University in Ontario, Canada.
Zwarenstein’s research focuses on health care program development and evaluation in Canada and internationally, especially in South Africa, where he holds professorships at Stellenbosch University and the University of Cape Town. His interest focuses on optimizing health care delivery through research on effectiveness.
