Medpace Holdings Inc.

11/18/2024 | Press release | Distributed by Public on 11/18/2024 16:27

Advancements from AUGS PFD Week

Exploring Advancements in Personalized Medicine, Sexual Health, Essential Endpoints, and Health Equity in Clinical Trials

Upon their return from AUGS PFD Week 2024, Medpace Women's Health experts Beth Tulip, Rujin Ju, MD, MSCR, FACOG, and Aparna Shah, MD, FACOG, highlighted several significant advancements in women's health clinical research and trials. Their insights reflect a dynamic landscape shaped by trends such as the emergence of personalized medicine via new technologies, the growing focus on quality-of-life metrics, innovative strategies that address health disparities in clinical trials and more:

Advancements in FemTech

Urogynecology is expanding beyond traditional therapies for pelvic floor disorders by utilizing novel technologies. These technologies continue to evolve with sophisticated health tracking, diagnostics, and digital solutions. By offering deeper insights through real-time data, FemTech represents a promising area for future consideration; FemTech may ultimately revolutionize the way data is captured in clinical trials, enhancing both the precision with data is captured and overall trial efficiency.1

Personalized Medicine for Women's Health

Advances in personalized medicine are transforming women's health, particularly through machine learning models that enable tailored treatments for complex conditions like pelvic floor disorders. By analyzing patient-specific data, these models allow clinicians to predict outcomes and design interventions that maximize effectiveness for each individual. Not only does this enhance therapeutic precision but also represents a valuable pathway for biopharma companies to develop highly targeted women's health therapies.1

Addressing Health Disparities and Equity

The commitment to addressing health disparities is critical in women's health research. Strategies to promote diversity, equity, and inclusion in clinical trials and broaden access are essential to creating therapies that reflect real-world effectiveness across diverse populations. Inclusive recruitment and culturally adapted protocols are central to these efforts, ensuring clinical data validity and fostering trust in historically underserved groups. 2,3

Expanding Focus Beyond Mortality to Quality-of-Life Metrics

While mortality has been a long-standing focus, there's a clear shift toward quality-of-life metrics in women's health trials. Pain management, physical functionality, and mental health are now essential endpoints, particularly for chronic conditions like pelvic floor disorders which tend to have significant negative impact on quality of life but are not generally life-threatening conditions. These metrics not only capture treatment impact more holistically, but also align with the broader patient-centered approach biopharma companies are increasingly adopting.4

Hormone Therapy Research and Non-Hormonal Alternatives

New advancements in hormone therapy and non-hormonal alternatives are providing options for managing menopause and other hormone-related conditions. With patient variability in hormone response, the demand for a range of therapeutic choices is strong. These developments offer new avenues for targeted trials in menopausal and reproductive health.5

Advancements in Surgical and Non-Surgical Treatments for Pelvic Floor Disorders

Innovative techniques in surgical and non-surgical treatments are enhancing patient outcomes and recovery for pelvic floor disorders. Minimally invasive procedures, novel device-based therapies, and regenerative techniques are opening safer, more effective options-ultimately redefining standard care.1,6

Emerging Therapies for Chronic Pain Syndromes

Chronic pelvic pain and interstitial cystitis are gaining traction in the clinical development space, signaling a ripe opportunity for innovation. These conditions have historically been understudied, creating a significant gap in effective treatment options. The significant negative impact on quality of life and the increasing attention from healthcare professionals suggests the real need for biopharma companies to develop groundbreaking solutions that address these women's health challenges.7,8

Leveraging Partnerships to Advance Innovation

Effective partnerships, particularly with CROs, are instrumental in driving innovation in women's health. Collaborative efforts facilitate resource sharing, streamlined processes, and enhanced trial design. By working with a CRO experienced in women's health, biopharma companies can accelerate timelines and bring innovative therapies to market more safely and efficiently.

As a global clinical research organization known for taking on some of the most complex women's health research studies, Medpace remains at the forefront of these transformative trends.

Didn't get the chance to connect with our experts at AUGS PFD Week? We welcome the opportunity to discuss your upcoming clinical development projects. Contact our women's health experts today.

Your Next Breakthrough Starts Here

When you partner with Women's Health CRO Medpace, medical leadership is fully embedded within the clinical trial process from inception to completion to help accelerate development. Your trial will benefit from our in-depth knowledge of disease processes and pathophysiology unique to women, relevant outcome measures, and standards of care.

Medpace medical and operational leadership in Women's Health spans multiple therapeutic areas and indications, including Gynecology, Urogynecology, Oncology, Endocrinology and Metabolic Disease, and Infectious Disease and Vaccines (ID&V), ensuring that you will have the medical and operational teams most suitable to your clinical trial.

List of References

  1. Business Wire. (2024, October 24). PFD Week 2024 Abstract Shows Model for Predicting a Woman's Success With First-Line Treatment for Incontinence [Press release]. https://www.businesswire.com/news/home/20241024780650/en/PFD-Week-2024-Abstract-Shows-Model-for-Predicting-a-Woman%E2%80%99s-Success-With-First-Line-Treatment-for-Incontinence ↩︎
  2. Warner, K. J., Brown H. W., & Jackson, T. (2024, October 23). If They Care About You, You Get Better Results: A Qualitative Analysis [Conference session]. AUGS PFD Week, Washington, DC. ↩︎
  3. Larkins-Pettigrew, M, & Trowbridge, E. R. (2024, October 25). ABLE Lecture: Optimizing Urogynecological Care through a Social Justice Lens [Conference lecture]. AUGS PFD Week, Washington, DC. ↩︎
  4. Guess, M. K., Lu, H., Liang, R., Burkett, L., Chen, B., Burnett, L. A., Pezzillo, M.D., Peña, B., Baghaki, S. S., Connell, K. A., Artsen, A. M., Kelley, R. S. (2024, October 23). Impact of Systems Biology on PFDs: From Pathogenesis to Tissue Regeneration and Recovery [Conference workshop abstract]. AUGS PFD Week, Washington, DC. ↩︎
  5. Dubinskaya, A., Vaccarao, C. M., Rubin, R., & Klos, K. (2024, October 23). The Intersection of Urogynecology, Sexual Health, and Hormone Therapy [Pre-conference workshop]. AUGS PFD Week, Washington, DC. ↩︎
  6. Alperin, M. (2024, October 24). Mini State of the Art: Regenerative Medicine in Urogynecology: Where We Are and Where We Want to Be [Concurrent session]. AUGS PFD Week, Washington, DC. ↩︎
  7. Handa, V. & High, R. (2024, October 25). Interstitial Cystitis, Pelvic Pain, Complications [Concurrent session]. AUGS PFD Week, Washington, DC. ↩︎
  8. Namugosa, M., Haraki, A. S., Ritts, R., Jr., Badlani, G., Evans, R. J., & Walker, S. (2024, October). Clinical Correlates of Endometriosis in Patients with Interstitial Cystitis [Conference poster]. AUGS PFD Week, Washington, DC. ↩︎