OverviewJoin Us in Accelerating New Treatments for PCOS
Polycystic Ovary Syndrome
Drug Development Meeting
To provide the FDA, medical product developers, the scientific community, and other stakeholders with a greater understanding of the experiences, perspectives, needs, and priorities of PCOS patients to support the development of FDA-approved treatments for PCOS.
Listen to patient voices as they describe the impact of living with PCOS to identify their priorities and goals for PCOS management and their experiences with current options for PCOS symptom management.
Consider endpoints and biomarkers for drug development trials and compare these with patient experiences to determine the clinical effectiveness of proposed treatments and align them with patient priorities.
Who Will Benefit from the PCOS EL-PFDD Meeting?
Patients and Caregivers
The PCOS EL-PFDD Meeting offers patients the opportunity to:
- Help shape and accelerate the development of new PCOS-focused treatments.
- Have their voices heard, directly informing the FDA and other stakeholders about the daily impacts and health effects of living with PCOS.
- Share their perspectives on the effectiveness of existing treatment and management options.
- Highlight their unmet needs and priorities for new treatments.
U.S. Food and Drug Administration (FDA)
The PCOS EL-PFDD Meeting and summary reports can aid FDA staff in:
- Acquiring patient insights for more informed benefit-risk evaluations of drugs, biologics, and devices under review.
- Advising drug sponsors on their development programs.
- Obtaining first-hand patient accounts of medication side effects, providing a nuanced understanding that can enhance post-market safety monitoring.
- Understanding what patients feel is lacking in current treatment options.
Industry and Pharmaceutical Companies
The PCOS EL-PFDD Meeting can help industry:
- Gain an in-depth understanding of patients’ experiences, symptom burden, and treatment history.
- Learn the multiple factors influencing patients’ treatment choices and trial participation.
- Identify unmet needs in PCOS care to drive more effective drug development.
- Obtain insights to design patient-centered clinical trials tailored to better meet the needs and priorities of PCOS patients.
- Foster important relationships needed for success in developing new PCOS therapies, diagnostics and devices. Patient and other stakeholder engagement is essential at all stages, ranging from initial discovery and preclinical phases to post-FDA approval and outcome assessment.
Researchers and Clinicians
The PCOS EL-PFDD Meeting can help researchers and clinicians:
- Better understand the lived experience of PCOS patients, enriching the context for clinical decisions and research directions.
- Gain insights from patients’ perspectives about the effectiveness, side effects, and other drawbacks of current treatment options, informing both research aims and clinical practice.
- Identify new research questions or gaps in existing knowledge, serving as a catalyst for innovative studies that can address unmet needs in PCOS care.
- Incorporate patient feedback to improve research and clinical processes and design.
- Enhance patient-provider communication by learning what information is most valuable to patients, improving patient satisfaction and treatment plan adherence.