Closing the Gender Gap in Clinical Research

Despite progress across the industry over the last few decades, significant challenges remain today in recruiting and retaining women for clinical studies. Experts at the PPD clinical research business of Thermo Fisher Scientific elaborate on how an in-depth understanding of women’s health can inform new solutions that close the gender gap in clinical research.

To successfully execute a clinical trial, the target patient population must be included. Historically, though, women have been — and remain — underrepresented in clinical research. Regulatory guidance for the inclusion of women and diverse populations was first issued in the 1970s, but the gap persists.

Investments in clinical development specific to women’s health amount to a small fraction in overall clinical development spend, and there is a need to increase women’s participation in clinical trials across therapeutic areas. So how can this gender gap in clinical research be closed?

A number of barriers to participation in clinical trials are unique to women. By considering these barriers from the earliest stages of trial design and protocol development, drug developers and clinical trial sponsors can remove the obstacles that have traditionally precluded women from taking part and achieve a truly patient-centric approach to health research.

More specifically, drug developers can address the gender gap in clinical research by:

• Increasing the flexibility to participate: Utilizing telemedicine, technology and decentralized trials are powerful tools for recruiting and retaining women who have work, family and other competing priorities.
• Ensuring protocols are relevant: Updating protocols to remove outdated measurements, such as body mass index (BMI), can expand the candidate pool for studies.
• Being more effective communicators: Possessing a strong cultural competence and the ability to communicate with empathy about challenging topics can ease negative feelings about participating in a trial.

Dig deeper into ways to facilitate successful clinical studies for a broader range of women’s health indications with this digital and decentralized solutions article, written by three experts from the PPD clinical research business of Thermo Fisher Scientific.