Just-In-Time in Community-Based Practices

Society of Clinical Research Associates, Denver, Colorado, September 2007

H.M. Newman, E.A. Spradley, D.E.H. Bailey; Pharmatech, Inc., Denver, CO

Background

In the US, adult oncology patient enrollment in clinical trials is estimated at only 4% (Cancer 2006; 106(2):426-33). This is a major bottleneck in the development of new cancer treatments, especially for rare indications, such as stage IV pancreatic cancer in treatment-naïve patients. To overcome the challenge of low enrollment in clinical trials specifically for rare indications, Pharmatech has developed the Just-In-Time (JIT) approach for community-based study sites. 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 the site is activated prior to screening for eligible patients. We postulated that the JIT approach would impact patient accrual.

Methods

With the JIT approach, a central IRB approved protocol was presented to 38 research-ready community-based study sites but only 8 sites with a potential patient obtained IRB-site approval over a 7 month period. Within 5-10 business days after identifying a potential patient, sites obtained IRB approval, the investigators at the site were trained, received study materials, and dosed the first patient. We compared patient accrual information from the traditional site activation conducted by the sponsor to the JIT approach used by Pharmatech for this study.

Results

Sites participating in the JIT approach accrued subjects at greater than twice the rate of traditionally activated sites. The JIT approach eliminated non-enrolling sites, which increased sites’ and sponsor’s satisfaction with enrollment. JIT furthermore enhanced patient options by providing access to a novel treatment alternative for this rare indication even at smaller research sites.

Conclusions

While JIT has its own challenges and limitations, patient accrual rate, enrollment success and trial-related cost in this pancreatic cancer study were markedly better with the JIT approach than with the traditional approach. Expanding the JIT approach to other rare indications and to trials that require specific genetic tumor-profiles will show whether these results are reproducible and whether JIT is a viable approach for trials with challenging eligibility criteria.