Expertise in women's health clinical trials
As funding increases for women’s health initiatives, including from non-traditional sources, drug developers are focusing on the enormous opportunities presented by this untapped market and perennially underserved, under-researched population. Disorders that disproportionately affect women, or impact women differently, such as autoimmune conditions, cardiovascular diseases and mental health conditions, are receiving attention thanks to investments by private equity firms, government grants, and philanthropists alike, in response to a ground swell of demand from women and care givers. First in class compounds are advancing for the treatment of symptoms of menopause, pain associated with endometriosis, obstetric and non-obstetric indications in pregnant and post-partum people, and reproductive health, to name just a few. At the same time, innovative digital solutions for diagnostics and telehealth are capitalizing on the trend toward proactive self-care.
Yet researchers must design clinical trials to capture reliable data that can be affected by a host of complex physiological factors and biological processes. Strategies for selecting optimal efficacy endpoints, stringent dosing assessments, PK/PD modeling based on the target population, including placental and breast milk transfer analyses– these are essential for demonstrating product safety. In fact, according to the World Economic Forum, medicines are 3.5 times more likely to be withdrawn for safety risks in women.1
Protocols must incorporate the realities of the participant burden, with sensitivity to privacy concerns, social stigma, and cultural factors unique to some medical conditions. Avoidance of invasive procedures is paramount, while time commitments must be minimized to accommodate busy lives with numerous responsibilities. All of this is key to recruitment and retention.
Understanding the opportunities, the challenges, and the experience of trial participants is fundamental to running successful clinical trials and ultimately, to product approval and market acceptance. Parexel has successfully completed multiple large trials in women’s health, resulting in a strong established network of sites and personal relationships with investigators and key opinion leaders.
Our medical specialists in women’s health represent an effective mix of longstanding industry experts and newer entrants knowledgeable of current clinical practice through recent patient experience. This outstanding staff is augmented by our own hospital-based early phase clinics and dedicated study startup, data management, biostatistics, and medical writing teams. These broad capabilities are available to large enterprises as well as biotechs that can take advantage of comprehensive, integrated solutions scaled for smaller companies.
Today, research has evolved beyond a focus on individual organs toward recognizing that a single disorder may well affect a woman’s entire body and wellbeing. Parexel has deep experience in indications especially prevalent in women across therapeutic areas, including rheumatology, cardiovascular disease, neurological disorders, obesity, and oncology.
Our comprehensive expertise encompasses preadolescent care, menstrual and pelvic health, contraception, fertility, pregnancy, menopausal care, and mental health. We offer a wealth of experience conducting clinical research across the full spectrum of global services for Phase I-IV studies.
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