The above visual lays out a range of specific pain points for each of these three layers; while the severity and solution to each may range by sponsor, trial protocol and therapeutic area, L.E.K. has consistently encountered these as the core challenges. This range of pain points across the life cycle of a trial creates inefficiencies, from timing delays to poor patient retention, ultimately resulting in no individual stakeholder group being well served by the status quo. Another factor heightening tensions is the fact that these difficulties are often self-reinforcing and further stress dynamics between stakeholders.
One example of this self-reinforcing tension is when sponsors see slow enrollment or failure to enroll at a site and they may push for more from the site. The site is typically operating in a negative cash flow situation, given the nature of reimbursements and delays in payments, stressing an already resource-constrained operation. Ultimately, this leaves less bandwidth for the sites to drive patient care and can leave potential or current trial participants feeling unappreciated and lacking in information. While the metrics for any one sponsor vary, many difficulties are universal (e.g., trial sites failing to be paid on time or lengthy travel times for patients) and pose significant cost risks for sponsors.
Need for an integrated approach
Each sponsor’s situation is unique — from the volume, type, modalities and design of the trial portfolio to the therapeutic area(s) they play in to the stage of development — and therefore, the specific point solutions to build their strategy and enhance execution must be unique. An integrated clinical trial strategy requires balancing all these factors across four key areas.