Revolutionizing oncology patient enrollment in clinical trials: Just-in-time approach

Abstract

6577 Background: In the US, adult oncology patient enrollment in clinical trials is estimated at 4% (Cancer 2006; 106(2):426–33). This is a major bottleneck in the development of new cancer treatments, especially for rare indications, like stage IV pancreatic cancer in treatment-naive patients. To overcome the challenge of low enrollment in clinical trials, Pharmatech developed the Just-In-Time (JIT) approach. JIT expands the potential patient population and allows research sites to pre-identify patients using standard of care information prior to site activation. This differs from a traditional approach where sites are activated prior to screening for patients. We postulated the JIT approach would impact patient accrual. Methods: With the JIT approach, a central IRB-approved protocol was presented to 38 research-ready sites but only 8 sites with a potential patient obtained IRB-site approval over a 6 month period. Within 5–10 business days after identifying a potential patient, sites obtained IRB approval, investigators at the site were trained, received study materials, and dosed the first patient. We compared traditional site activation conducted by the sponsor to JIT approach in this study. Results: Traditional approach vs JIT approach: No.of patients enrolled: 42 vs 18; No.of months open: 19 vs 6; No. of sites open: 13 vs 8; No. of non-enrolling sites: 2 vs 0; Patient accrual rate (pts/mo/site): 0.17 vs 0.38. Sites participating in the JIT approach accrued subjects at >2x the rate of traditionally activated sites. The JIT approach eliminated non-enrolling sites, increasing sites’ and sponsor's satisfaction with enrollment. JIT also enhanced patient options by providing access to a novel treatment alternative for this rare indication even at smaller research sites. Conclusions: With JIT, patient accrual rate, enrollment success and trial-related cost in a pancreatic cancer study were markedly better than with the traditional approach. Expanding JIT to other rare indications and to trials requiring specific genetic tumor-profiles will show whether these results are reproducible and whether JIT is a viable approach for trials with challenging eligibility criteria. No significant financial relationships to disclose.