Addressing the “unique drug development issues” raised by female participation in clinical trials, US-based contract research organisation (CRO) INC Research has launched a Women’s Health Division headed by a former FDA and NIH employee.

Steering the initiative is Dr Cynthia Madden, who has worked for the US Food and Drug Administration’s (FDA) Division of Investigational New Drugs and received additional training at the US National Institutes of Health (NIH).

Dr Madden “has 19 years of direct clinical care experience, focusing on women’s health issues, and has developed a distinctive acumen for the complex underlying medical, recruitment and retention issues which so dramatically impact the success of clinical trials in women”, said John Potthoff, chief operating officer of INC Research.

It is a common complaint that, in addition to the general difficulties encountered in recruiting and retaining clinical trial participants in established markets such as the US, women are either under-represented or undervalued in this context.

The Women’s Health Division at INC Research “combines clinical expertise in the diseases that most affect women with an understanding of the challenges our customers face in developing drugs for this population that must factor in gender and age nuances”, Dr Madden commented.

The INC team “takes a highly collaborative approach” to understanding and planning for these challenges, so that they can successfully execute all phases of clinical trials and development programmes, she added.

Using its Trusted Process methodology, INC Research “has already developed a solid reputation for the successful conduct of clinical trials in women’s health such as breast cancer trials in our Oncology Division and fibromyalgia trials in our CNS Division”, Potthoff noted.

Based in Raleigh, North Carolina and with a presence in 32 countries worldwide, INC is a full-service CRO with particular expertise in central nervous system research. Other specialities include women’s health, oncology, infectious diseases and paediatrics.