Health Decisions extends record of successful enrollment in largest-ever contraceptive trial of its type
Durham, North Carolina—July 24, 2013
Health Decisions, Inc., the full-service CRO of choice for forward-looking biopharma and medical device companies, today announced early completion of enrollment for a 3,384-subject phase III registration study ofEvofem’s Amphora® nonhormonal contraceptive gel.
The global trial compares Amphora to Conceptrol®, the brand name of nonoxynol-9, and the only spermicidal gel currently approved by the FDA.
“We are pleased that our focus on efficiency enabled us to enroll this important study well ahead of schedule,” said Health Decisions CEO Michael Rosenberg, MD, MPH. “Our ability to use technology to enroll studies faster and to better retain subjects enables us to generate information more quickly than industry norms. This study is a good example and will provide Evofem with an earlier market entry than would otherwise have been possible.”
Dr. Rosenberg attributed successful enrollment of the Amphora study to the power of Agile Clinical Development, Health Decisions’ award-winning, technology-leveraged approach to running clinical trials based on immediate, actionable information from the field. “Our approach and supporting technologies enable us to enroll over 80% of our studies on time or early when the rest of the industry is enrolling about 80% late,” Rosenberg said. “In the Amphora study, our integrated adaptive enrollment techniques enabled us to enroll almost 3,400 subjects three to four times faster than previous trials of similar products that enrolled less than half as many subjects.”
Health Decisions enrolled the Amphora study at a rate of 125 subjects per month compared with 38 subjects per month and 30 subjects per month for previous large studies of similar products. One such study with a target enrollment of 1,800 subjects was terminated without meeting its enrollment goals.
“We are very pleased with the progress on the development of Amphora,” said Tommy G. Thompson, former US Health and Human Services Secretary, and Chairman of the Evofem Board of Directors. “Evofem is committed to providing women around the world with greater contraceptive choice and we expect Amphora to fill a critical gap in the market as an inexpensive, easy-to-use product that is womancontrolled and used only when necessary, on-demand.”
Dr. Rosenberg also noted, “Our integrated adaptive monitoring approach works on the same real-time principles as adaptive enrollment and also provided striking benefits in the Amphora trial, simultaneously reducing monitoring costs and increasing data quality.” Health Decisions won the prestigious 2013 CIO 100 Award for its innovative adaptive monitoring technology.
About Health Decisions
Health Decisions is the leading clinical research organization (CRO) in Agile Clinical Development, providing proactive trial management based on real-time actionable information, enabling decisions that accelerate clinical studies and programs. For the drug and device industries, Agile Clinical Development provides a way to get new products to market faster and at lower cost. For the public, it means earlier access to improved treatments and diagnostics at more affordable prices. Founded in 1989, Health Decisions has conducted a range of successful clinical trials involving tens of thousands of patients, consistently reducing sponsors’ financial risk and time to market. Privately held, Health Decisions is headquartered in Durham, NC and operates on all five continents.
Evofem LLC is a privately held biotechnology company that brings advanced prescription and consumer products to global markets. Through its subsidiaries, Evofem Inc. and Cosmederm Bioscience, Evofem discovers, develops and commercializes prescription and over-the-counter products, in the areas of dermatology, pain management, feminine care, contraception, and the prevention of sexually transmitted infections. In February 2013, Evofem entered into a strategic alliance with WomanCare Global, a nonprofit organization whose mission is to provide access to quality, affordable, women’s healthcare products through a sustainable supply chain in over 100 countries, with a particular focus on under-served markets in Africa, Asia, and Latin America. Through this alliance, WomanCare Global provides sales, marketing and global distribution support to Evofem’s products.