Webinar Offers PI and Patient Perspectives on HMB Clinical Trials
Andrea S. Lukes, MD, Health Decisions CMO, and a Trial Subject Provide Unique Insights into Key Issues in Clinical Trials of Treatments for Heavy Menstrual Bleeding (HMB)
Durham, North Carolina. Health Decisions, Inc., the full-service clinical research organization of choice for forward-looking biopharma and medical device companies and a leader in women’s health and diagnostics studies, today announced a complimentary webinar on key issues in clinical trials evaluating new treatments for heavy menstrual bleeding (HMB).
Health Decisions Chief Medical Officer Andrea S. Lukes, MD, MHSc, FACOG, will provide a clinical overview of HMB that covers anatomical and nonanatomical disorders associated with HMB as well as bleeding disorders. Dr. Lukes will discuss strategies for patient recruitment, prescreening, screening and retention and will introduce a patient who participated in an HMB trial to share her experiences. Registration for the webinar is open. “Heavy Menstrual Bleeding: Medical Background and PI and Patient Perspectives on Clinical Trials,” will take place Tuesday, May 15, 2018, at 1 pm EDT / 10 am PDT.
“Our mission is to improve healthcare outcomes for women worldwide and HMB is an indication in which outcomes need to improve,” stated Health Decisions’ Chief Executive Officer Patrick Phillips, BSc (Hons), D.Phil. “As an authority on clinical development of HMB therapeutics and an experienced Principal Investigator in HMB trials, Dr. Lukes can provide developers with unique insights into conducting these trials successfully.”
“The unusual challenges of HMB clinical trials include the patient-screening process, a high screen-fail rate and the requirement for endpoints based on the alkaline hematin method of assessing blood loss,” Dr. Lukes said. “To conduct trials efficiently, sponsors of HMB studies need to understand the issues in these trials from both the PI and patient perspectives.”
Dr. Lukes has been a PI in numerous HMB trials, advised sponsors developing new HMB treatments and participated in related FDA meetings. She co-founded and served as the Director of Gynecology for the Women’s Hemostasis and Thrombosis Clinic at the Duke University Medical Center before establishing the Carolina Women’s Research and Wellness Center (CWRWC), a leading private gynecologic practice and clinical research center.
About Health Decisions
Health Decisions is a full-service CRO offering therapeutic, operational and regulatory excellence for clinical development of drugs, diagnostics, medical devices and combination drug/devices in all areas of women’s health. Based on therapeutic and operational experience and investigator relationships developed in studies conducted over the past 28 years, Health Decisions successfully addresses the challenges of developing diagnostics in all therapeutic areas and drugs and devices in areas including reproductive and sexual health, menopause, pain management, osteoporosis/osteoarthritis, reproductive psychiatry, gynecologic oncology and general gynecology indications. Health Decisions is headquartered in Durham, NC.
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lhammill @ healthdec.com