Women's Health

Clinical Research: Phase 1 - Phase 4

Considerations for Clinical Studies in Heavy Menstrual Bleeding

Heavy menstrual bleeding (HMB) is one of the most common gynecologic disorders among women of reproductive age, accounting for up to one-third of all gynecologic office visits.1 HMB refers to bleeding associated with regular ovulatory cycles and involves blood loss greater than 80 ml per month. It is a subcategory of abnormal uterine bleeding (AUB),...

Clinical Research: Phase 1 - Phase 4

Gaining Patient Input: How to Ensure Patient Interests Remain Top of Mind

Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every step of the clinical research process. Regularly engaging women, their physicians, and health advocates helps...

Clinical Research: Phase 1 - Phase 4

Teaming Up with Sites During Trial Design

According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the substantial amendments are implemented during the study enrollment period, mainly due to difficulties in recruiting...

Clinical Research: Phase 1 - Phase 4

Designing Trials for Patients

Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical...

Clinical Research: Phase 1 - Phase 4

Addressing Research for Women from Every Angle

When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. From protocols and endpoints, to recruiting strategies and messaging, these trials have to take into account the unique needs, expectations and regulatory requirements of a totally female population. Having spent more than 20 years in this space,...

Clinical Research: Phase 1 - Phase 4

Women-Centric Approach to Clinical Trials

Introduction For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology. It wasn’t until 1993 that the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government. This has resulted in...

Clinical Research: Phase 1 - Phase 4

Premier Insight 277: Optimizing Enrollment for a Phase 3 Clinical Trial During a Global Pandemic

Background A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV). We leveraged our expertise in study design and execution along with our extensive network of OB/GYNs to deliver a successful clinical study ahead of...