National Women’s Health Week Part 3

With hands-on experience, site staff can provide valuable insights for proactively addressing challenges in clinical trials

By: Dr. Andrea S. Lukes, MHSc, FACOG, Chief Medical Officer, Health Decisions

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 patients. With patient insights at their fingertips, effectively involving physicians and site staff during the trial design process can drive efficiencies that may improve recruitment efforts.

Find the right sites

Successful women’s health clinicians thrive because they value what an individual woman experiences and focus on developing positive patient relationships. By genuinely listening, we pick up on the subtleties of what matters most.

Engage them early on

It’s estimated that protocol amendments cost the industry $20 billion a year in direct and indirect costs. Decisions made as a study program is designed have the greatest potential impact on cost and study timelines. Engage sites as advisors during the design process to ensure clarity within the final protocol and mitigate operational risks.

Learn from the past

Experienced sites are full of valuable lessons learned. Understanding the successes and failures of previous trials can lead to more informed decisions as a new study is designed. Ask for case studies and anecdotes to shape plans and ideas. Evolve strategies by considering common themes.

Discuss patient communication

Women are often compelled to participate in a study because of site-driven education. A site’s approach to patient interactions can have a significant impact on study success. Knowledge from day-to-day patient engagement can shed a light on best practices for motivating and educating patients. Winning strategies should be discussed when sites are onboarded.

As a healthcare provider and principal investigator, I firmly believe that listening to patients is one of the most important aspects of effective patient care and successful clinical studies. Having the opportunity to collaborate with Sponsors early in study planning can improve enrollment, retention, and create a better patient experience. At Health Decisions, we regularly engage sites as we refine our strategies in women’s health research. In honoring National Women’s Health Week, we celebrate these partnerships and the innovative research we are lucky to support together.

This blog post is the last in a three-part series honoring National Women’s Health Week. Read the rest of the series: