T-11: Assessing Patient Availability and Patient Burden: Where Trials Go Wrong Today and How They Can Improve Tomorrow
Poster Presenter
Diane Carozza
Managing Senior Engagement Consultant
Medidata Solutions United States
Objectives
The objective of the abstract is to identify methods that sponsors use to improve the availability of patients relative to recruitment and reduce patient burden during a clinical trial.
Method
In partnership with Scrip and Penton Research, Scrip subscribers were asked to participate in an online survey. There were 66 qualified survey respondents. The study’s analysis was based on the results of those 66 respondents.
Co-author is Stacey Yount, MA, Managing Principal, Strategic Consulting
Results
Timely patient enrollment and retention in clinical trials is critical to efficient development programs. Sites that successfully identify, recruit and retain participants enable their studies to finish faster, avoiding the costly and time-consuming obstacles that blight trials. This makes knowledge of patient availability a valuable resource.
One long-standing enrollment challenge is that sponsors need better ways to develop protocols with an objective understanding of the patient burden associated with the procedures and timelines of the trial and identify trial sites with access to patients that meet their inclusion/exclusion criteria. The burden placed on clinical trial participants, along with site staff and investigators, significantly contributes to high drop-out rates in both groups.
The successful recruitment and retention of viable clinical trial patients and qualified investigators are longstanding challenges for the pharmaceutical industry. A 2017 survey of clinical operations professionals found almost 70% work with country affiliates and local thought leaders to assess patient availability when designing clinical trials. The second most widely-used approach is for companies to base assessments on the prior clinical trial experience of an investigator. These are subjective, time-worn approaches that are unlikely to improve patient recruitment and retention.
The survey also identified that sponsors are open to objective data-driven technologies to improve the precision of patient availability decisions and the quantification of patient burden. However, awareness about these solutions is limited, with only 40% of respondents “somewhat,” “very familiar” or “currently using” the software solutions. The good news is that 100% of respondents using the data-driven technologies conclude that they add “significant” or “moderate” value.
Conclusion
There’s a unique opportunity to innovate in this space. Where are the patients and what is the burden we are placing on them in this study? Sponsors are trying to answer these objective questions with subjective knowledge. However, vendors such as Medidata Solutions are developing novel analytical tools backed by high-quality data that give hope to the recruitment and retention problems that have dogged the industry for decades. Sponsors who adopt and enable these technologies will give themselves an advantage in patient recruitment and retention.
