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Published on: July 25, 2020
A Patient Focused Solution for Enrolling Clinical Trials in Rare and Selective Cancer Indications: A Landscape of
Eric B Lynam1, Jiin Leaw, Matthew B Wiener
1Pharmatech Oncology, Inc., 789 Sherman Street, Suite 600, Denver, Colorado 80203.
Abstract:
Participation of adult cancer patients in US based clinical trials has remained near 3% for decades. Traditional research methodology reaches a small fraction of the target population with a fixed number of predetermined sites. Solutions are needed to ethically increase patient participation and accelerate cancer trial completion. We compared enrollment outcomes of traditional and patient focused research methodologies. A patient prioritized method (Just-In-Time, JIT) was implemented in parallel with traditionally managed sites in three cancer trials. JIT research sites were initiated after candidate patients presented, while traditional sites were initiated in advance. JIT sites enrolled with mean rates no less than, and up to 2.75 fold greater than, traditional sites. Mean patients enrolled per site was comparable (JIT-1.82, traditional-1.78). There were fewer non-enrolling JIT sites (2/28, 7%) compared to traditional sites 19/52, 37%). This retrospective analysis supports JIT as a prospective solution to increase cancer clinical trial enrollment and the efficiency of clinical trial administrative activities.
Insights
Just-In-Time (JIT) clinical trial enrollment methods significantly increased patient participation compared to traditional approaches. This patient-focused strategy accelerates trial completion and improves administrative efficiency in cancer research.
Area of Science:
- Oncology
- Clinical Research Methodology
- Health Services Research
Background:
- Adult cancer patient participation in US clinical trials has stagnated around 3% for decades.
- Traditional research models limit patient access through fixed, predetermined sites, hindering trial completion rates.
Purpose of the Study:
- To compare the enrollment outcomes of traditional clinical trial methodologies with a patient-focused approach.
- To evaluate the effectiveness of the Just-In-Time (JIT) research methodology in increasing patient participation and trial efficiency.
Main Methods:
- A patient-prioritized Just-In-Time (JIT) research method was implemented concurrently with traditional research sites across three cancer trials.
- JIT research sites were activated after candidate patients were identified, contrasting with traditional sites activated in advance.
Main Results:
- JIT sites demonstrated enrollment rates equal to or up to 2.75 times greater than traditional sites.
- The average number of patients enrolled per site was comparable between JIT (1.82) and traditional (1.78) methods.
- Fewer JIT sites failed to enroll any patients (7%) compared to traditional sites (37%).
Conclusions:
- The Just-In-Time (JIT) methodology shows significant promise for enhancing cancer clinical trial enrollment.
- JIT represents a viable solution to improve the efficiency of clinical trial administrative activities and accelerate research.
- This patient-focused approach ethically increases participation and supports faster trial completion.
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