Health Decisions recognizes the importance of increasing the participation of women in clinical trials in order to identify differences in female response, provide female-specific prescribing information and reduce the number of adverse events experienced by women taking approved medications. Based on Health Decisions’ extensive experience as a women’s health specialty CRO, Project Manager Jessica Kappes, MBA, MT, CCRA offers some observations from women’s health clinical trials, many of which apply to trials enrolling female populations in other indications. Ms. Kappes has nine years of experience […]
Chief Medical Officer
Andrea Lukes, MD, MHSc, FACOG
As Health Decisions celebrates National Women’s Health Week (NWHW), we decided to sit down with our Chief Medical Officer, Andrea S. Lukes, MD, MHSc, FACOG, a practicing OB/GYN and active Principal Investigator as well as a CMO, to ask her thoughts on NWHW, key health issues for women at different life stages and women’s participation in clinical trials.
Why is National Women’s Health Week important to you?
A post in this blog during National Women’s Health Week 2016 discussed six areas of significant unmet medical needs in women’s health. This post for National Women’s Health Week 2018 provides an update on the status of product development in addressing three of those areas of unmet need.
- Increased availability of noninvasive diagnostics for health conditions like endometriosis
- Improved therapeutics for osteoporosis
- More effective therapeutics for female sexual dysfunction
In addition, this post will provide information on the clinical development of new treatments for heavy […]
The Health Decisions team attending ACOG 2018 – the Annual Clinical and Scientific Meeting in Austin April 27-30 – had a busy, enjoyable and productive week with our colleagues in the OB/GYN community. In keeping with its mission as a women’s health specialty CRO, Health Decisions sponsored and participated in the 5K Run/Walk for Women. Thanks to all who participated, including those in the snapshot. In addition to the fun run, we enjoyed and learned from a rich informational program at ACOG, beginning with the […]
Meeting planned enrollment timelines is a challenge in many clinical trials. Studies of novel products for treatment and diagnosis of women’s health conditions are no exception. Based on years of experience in women’s health clinical trials, the Health Decisions Clinical Affairs group has developed a methodology that has successfully accelerated start-up in studies in a variety of women’s health indications. In brief, key elements of the methodology include:
- Simultaneous activation of all or almost all investigational […]
March is Endometriosis Awareness Month, a reminder of the importance of ensuring that clinical development of novel endometriosis treatments progresses as rapidly as possible. This is an area of significant unmet medical need affecting approximately 10% of women of reproductive age worldwide – approximately 176 million women. While sometimes asymptomatic, endometriosis is often associated with infertility and pelvic pain. Up to 50% of women with endometriosis may also have to deal with infertility. Even more women with endometriosis […]
Women and their OB/GYNs can select from an enormous variety of contraceptive products today. This includes multiple categories of contraceptives – oral contraceptives, implants, intrauterine devices (IUDs) or systems (IUSs), injectables, patches, rings, diaphragms and spermicides. Within categories there is usually a choice of multiple products. With contraceptives already available in such variety, it would be easy to assume that opportunities in new contraceptive development are limited. However, many women and OB/GYNs see room for improvement of contraceptives in areas including comfort, convenience, reduction in […]
Health Decisions is hosting a complimentary webinar, “Critical Success Factors in Reproductive Health Studies: Practical Tips for Minimizing Timelines, Risk and Costs.” The webinar will be held January 24, 2018. Reproductive health developers are invited to register for the complimentary webinar.
The webinar will address the challenges of conducting reproductive health studies efficiently while also generating high-quality data to support successful regulatory submissions. Topics will include:
- Recruitment, including factors such as utilizing advocacy groups and […]
Pilot studies may seem unnecessary when your investigational diagnostic is performing superbly for lab professionals in your internal labs. Why waste time and money on a pilot study when you are witnessing excellent results in the lab day after day? After all, the goal of every development program is to obtain regulatory approval, market the product and generate revenue as rapidly as possible. Let’s be honest – it takes time to identify appropriate sites for a pilot study to evaluate real-world performance by intended operators, […]
Health Decisions is offering a complimentary webinar December 14, 2017 to assist diagnostics developers in addressing regulatory changes on both sides of the Atlantic and key operational issues such as the transition to subject-based testing. Changes at FDA include faster turnaround times for some diagnostics reviews. In the EU, new Device Directives will require developers to provide more extensive evidence to obtain CE Mark, in some cases changing considerations about whether to seek approval for a novel diagnostic in the US or EU first. […]