Expired and expiring patents for dozens of products are forcing the clinical research-based industry to streamline and quicken R&D. Yet, even as stakes for company R&D are intensifying, our stifling climate of risk aversion has decision makers falling back on the customary, rather than advocating for the exceptional. Unfortunately, this is the case even when it means passing up on a chance to gain real efficiencies in patient enrollment and retention, the most costly aspect of the clinical trial process.
We all know that over 80 percent of all clinical trials are now delayed up to six months due to enrollment and retention issues. The consequences are missed milestones, wasted patent exclusivity, and significant cost overruns, which in today’s climate are unforgiving. Clinical trial protocols are increasingly complex with more procedures, longer case report forms, and longer consent forms burdening clinical trial staff and patients alike. Regulators are requiring more clinical trials per compound, more patients for each clinical trial, and more follow-up data on patients, whether they complete the study or not.
So how do drug companies begin to streamline R&D in this contentious environment? (Hint: It’s not social media, everyone’s favorite strategy of hope.) It’s by taking another look at solutions that really work. This session will examine the true value of patient recruitment and offer cost analyses uncovering surprising facts about enrollment efficiency.
Joe O’Rourke,
Director
Joe has worked in clinical research for more than a decade, beginning by working as a research assistant for metabolic studies at Johns Hopkins through to his current role in business development. In his tenure at Acurian, Joe started within the Site Services group and worked directly with more than 2,000 sites helping to deliver new pools of high quality patients and ensuring they significantly lifted enrollment rates.
Joe began taking on additional responsibilities as a Project Manager where he oversaw recruitment and retention activities across large, multi-protocol Phase III programs. Joe launched Acurian's online recruitment services operational division, including the first large-scale recruitment activities on FaceBook and other online communities. In 2011, he moved into a new position developing recruitment strategies across all proposals and business development, before assuming responsibility for a set of strategic customers. Joe received his B.S. in Kinesiology at West Chester University and his Master's degree in Business Administration from Villanova University.
- The impact of declining enrollment rates on clinical trial efficiency
- Examining the time and dollar costs associated with customary enrollment options
- Understand the importance of Site Enrollment Rate (SER) as a function of cost efficiency
- Revealing the true value of patient recruitment
- Clinical Trial Operations
- Clinical Trial Outsourcing
- Clinical Research Director
- Clinical Research Manager
- Clinical Trial Manager
- VP
