It’s All About the Partnerships in Clinical Trials
Last week found us in Hamburg, Germany as a sponsor and presenter at the 11th Annual Partnerships in Clinical Trials (PCT) conference. Stephen Young, who leads Medidata’s Insights initiative, presented a case study on our Insights Council and shared metrics and industry benchmarks uncovered through our metrics database. Attendees were particularly interested in the data Steve shared on enrollment trends by global region and were surprised to learn that in the past four years, there has not been much of a push into emerging regions. Steve’s presentation also focused on monitoring and opportunities for risk-based monitoring and showed that source document verification (SDV) and on-site monitoring are both on the rise. Steve also shared that typical site monitoring costs are 30 percent of the total clinical trial budget—a tremendous investment for the industry—making a compelling argument for the need to adopt a more efficient risk-based approach. But Stephen’s presentation was just one of many insightful discussions at this clinical outsourcing event where pharmaceutical companies, sponsors, contract research organizations (CROs) and other industry leaders addressed minimizing risk through agile clinical development. As PCT came to an end, we had the opportunity to sit down with Ann Wang, vice president of clinical operations at Human Genome Sciences—a biopharmaceutical founded in 1992 that was recently acquired by GlaxoSmithKline—to hear her top PCT takeaways. Check out this video interview where Ann shares her event recap, including changes in the CRO industry, the role of the patient in clinical trials and the need for sponsors to really start to listen, share and show transparency. *Ann Wang is vice president of clinical operations at Human Genome Sciences, recently acquired by GlaxoSmithKline. *Stephen Young is director of product management at Medidata Solutions, overseeing our Insights initiative. You can reach Stephen via email.