Critical Success Factors in Reproductive Health Studies: Practical Tips for Minimizing Timelines, Risk and Costs

Health Decisions, the leading women’s health specialty CRO, is offering a webinar on addressing the challenges of conducting reproductive health studies efficiently and in a manner that produces high-quality data to support successful regulatory submissions. The webinar will address challenges in conducting reproductive health studies, including:

• Recruitment, with attention to the importance of factors such as utilizing advocacy groups and defining inclusion/exclusion criteria with care
• The importance of fully understanding and addressing the therapeutic, operational and design implications of FDA requirements for each reproductive health indication
• Proven methods for achieving accelerated start-up in reproductive health studies.

The webinar will draw on examples from studies in endometriosis, an OB/GYN indication that profoundly affects reproductive health; bacterial vaginosis, a common infectious condition that can contribute to infertility; and contraception, a critical indication for management of women’s reproductive lives that affects quality-of-life throughout the reproductive years. The speakers will present therapeutic and operational observations from studies in these specific indications, however, the operational solutions discussed will be applicable across the spectrum of reproductive health indications.

Health Decisions Chief Medical Officer, Andrea S. Lukes, MD, MHSc, FACOG, will discuss therapeutic and design considerations for all three indications as well as recruitment considerations in endometriosis studies. Health Decisions Head of Data Services, Clint Dart, MS, will discuss regulatory, design and operational considerations in studies of contraceptive drugs, devices and combination drug/devices. Health Decisions Head, Clinical Operations, Kevin Bickford, will describe proven techniques for achieving accelerated start-up in reproductive health studies, with examples from a registration study of a therapeutic for bacterial vaginosis.

Speakers

Andrea S. Lukes, MD, MHSc, FACOG, Chief Medical Officer, Health Decisions

Dr. Andrea S. Lukes is a board-certified OB/GYN, a Fellow of The American Congress of Obstetricians and Gynecologists and an expert on clinical development of women’s health products across a wide range of indications across the female lifecycle. Her areas of expertise include, but are not limited to, endometrial ablation, hysteroscopy, minimally invasive gynecology, bleeding disorders, uterine fibroids, contraception, menopause and vasomotor symptoms, hereditary cancer screening and prenatal counseling. Dr. Lukes advises Health Decisions and its clients on development and implementation of research protocols as well as communications and presentations to the FDA. An experienced principal investigator in industry-sponsored, NIH and CDC clinical trials, Dr. Lukes has conducted or overseen more than 80 clinical trials of investigational women’s health products, including both drugs and devices, in the last ten years. Dr. Luke’s articles have appeared in medical journals including Obstetrics and Gynecology, the American Journal of Obstetrics and Gynecology, Fertility and Sterility, and the Journal of Minimally Invasive Gynecology. Dr. Lukes received a bachelor’s degree and a combined medical degree and master’s degree in statistics from Duke University. She completed her residency at the University of North Carolina School of Medicine.

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Clint Dart, MS, Head of Data Services, Health Decisions

Clint Dart has approximately 15 years’ experience as a biostatistician, including designing, preparing, and reviewing clinical study protocols, with focus on statistical analysis and sample size/power calculations. Mr. Dart’s extensive experience in women’s health studies includes serving as Principal Investigator for Health Decisions in its role as Statistical and Clinical Coordinating Center for the Contraceptive Clinical Trials Network of the National Institute of Child Health and Human Development, a unit of the National Institutes of Health. At Health Decisions, Mr. Dart manages the biometrics and data-management groups and develops and provides guidance on analysis plans and reporting specifications, performs statistical analyses, interprets results and coordinates production of statistical and clinical reports. Mr. Dart has participated in trials involving a variety of devices and diagnostics as well as drug and biologics studies involving phases 1 – 3, and has led the statistical efforts for two pivotal studies that had successful regulatory filings. He has contributed to regulatory submissions in a variety of therapeutic areas, including contraception, hormone replacement and prostate cancer. Mr. Dart holds an MS in Statistics from the University of Georgia and a BS in Mathematics from the University of Cincinnati.

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Kevin Bickford, Head of Clinical Operations, Health Decisions

Kevin Bickford is a clinical operations executive with 20 years of clinical development experience spanning many therapeutic indications and virtually every phase of clinical research.  Mr. Bickford provides executive oversight for a focused, specialized, and dedicated Health Decisions Operations team specializing in women’s health. His experience includes providing team leadership and executive oversight for both sponsor and CRO companies and managing operational groups ranging from large global teams on multi-protocol development programs to small teams executing studies of investigational products for rare disease and orphan indications. Mr. Bickford’s experience in women’s health studies includes directing programs for accelerated start-up in a variety of indications. His therapeutic experience includes not only studies of novel drugs, but also studies of diagnostics, other medical devices and Over-the-Counter (OTC) drug reformulations. Mr. Bickford focuses the Health Decisions operational team on service delivery, effective partnership among study team stakeholders and effective risk, quality and resource management. He is skilled at analyzing operational and performance metrics to guide sponsor and provider team members toward the best path for successful study conduct. Mr. Bickford has a BS in Biological Sciences from the University of Vermont and certification from Northeastern University as an Emergency Medical Technician.

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