FDA approval of gonadotropin-releasing hormone (GnRH) antagonist elagolix as an oral agent for management of moderate-to-severe pain associated with endometriosis provides an important treatment option for a condition that compromises quality of life for approximately 10% of women of reproductive age. Types of pain associated with endometriosis include painful periods, painful ovulation, pain during or after sexual intercourse and chronic pelvic pain.
Clinical studies that provided a basis for FDA approval demonstrated that three out of four women given 200 mg of elagolix twice a […]
Health Decisions’ CEO Patrick Phillips Supports the #NextGenContraception Campaign
Health Decisions is a women’s health specialty CRO with extraordinary experience and capabilities in contraceptive research. For more than 20 years, Health Decisions has served as the Coordinating Center for the Contraceptive Clinical Trials Network of the National Institute of Child Health and Human Development (NICHD), a unit of the National Institutes of Health. In addition, Health Decisions has conducted many contraceptive […]
Health Decisions supports the recognition of July as Fibroid Awareness Month. Health Decisions’ Chief Medical Officer Andrea S. Lukes, MD, MHSc, FACOG, is a practicing OB/GYN and an active Principal Investigator with experience in uterine fibroid clinical trials. Dr. Lukes offers this blog post in support of fibroid awareness and clinical development of new fibroid therapeutics and diagnostics.
Fibroids are benign tumors of muscle within the uterus. The cumulative incidence by the age of 50 is […]
Development of a noninvasive diagnostic for endometriosis has long been a priority for researchers. For example, a workshop report from the 2011 World Congress of Endometriosis entitled Defining Future Directions for Endometriosis Research noted both the need for a noninvasive diagnostic and the challenge:
- A noninvasive test for the reliable diagnosis of endometriosis, and in particular early endometriosis, remains a priority. Specificity and sensitivity of any diagnostic test are key issues, with many patients having comorbidities, such as adenomyosis, irritable bowel syndrome, and […]
The Health Decisions team at DIA 2018 left with the impression that the biopharma industry values relationships with patient advocacy groups but use of such groups in study planning and protocol development remains the exception rather than the rule. Health Decisions’ Chief Medical Officer Andrea Lukes, MD, MHSc, FACOG, chaired a DIA forum entitled “From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design.” Clint Dart, Health Decisions’ Senior Director, Biostatistics and Programming, participated along with […]
Progress in male contraception, including male hormonal contraception, has captured the attention of mainstream media, as demonstrated by an article in the June 18 issue of Time Magazine, “This Man Wants to Be on Birth Control: Inside the race to develop a better male contraceptive.” (Subscription required.) Author Alexandra Sifferlin has provided an excellent overview of the field of male contraception as she did in an April 26 online piece, “Are We Finally Ready for the Male Pill?”
The print article […]
Health Decisions was pleased to participate in the 2018 HealthyWomen dinner, held at the Italian Embassy in Washington June 13, where the theme was “‘Alla Nostra Salute! To Our Health’ – Celebrating innovation that advances women’s health research and advocacy for future generations.” HealthyWomen is an independent nonprofit organization addressing one of many underserved needs in women’s health – the need for accurate information about women’s health issues and treatment resources.
The keynote speaker at […]
Health Decisions CEO, Patrick Phillips, BSc (Hons), D.Phil., attended BIO 2018 in Boston to meet with companies active in development of new therapeutic and diagnostic products to improve healthcare outcomes for women. After the conference, Dr. Phillips offered observations on a variety of trends in evidence at the conference and on Boston as a conference setting with significant current development activity in women’s health and a rich history as well. The primary […]
Partnerships drive biopharma development today more than ever, especially in clinical development. The scope of partnerships ranges from contracts to conduct individual studies to functional-service-provider arrangements or outsourcing agreements encompassing whole development programs and sometimes even the whole of a company’s clinical development activity. While clinical development partnerships are commonplace, they are seldom simple. Forming a clinical development partnership requires both parties to consider a host of issues, including but not limited to the following:
- the capabilities […]
The BIO International Convention convenes June 4 in Boston, MA. The City-on-a-Hill is an excellent setting for BIO for reasons including its role as a hotbed of both academic and commercial development. As a women’s health specialty CRO, Health Decisions sees another reason to appreciate Boston as a venue for BIO: the city’s history of advocacy in women’s health. For example, it was in Boston that a group of women came together, authored and published “Our […]