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Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs)
W N Kernan1, C M Viscoli, D Demarco
1Departments of Internal Medicine, Yale School of Medicine, New Haven, CT 06519, USA. walter.kernan@yale.edu
Neurology
|April 15, 2009
Summary
A new network strategy significantly improved stroke prevention trial enrollment by centralizing patient identification and outreach across multiple institutions. This approach led to higher recruitment rates, potentially accelerating research completion despite initial cost increases.
Area of Science:
- Clinical Trials and Stroke Prevention
- Health Services Research
- Network-Based Research Strategies
Background:
- Improving patient enrollment in clinical trials is crucial for advancing secondary stroke prevention research.
- Conventional recruitment methods often face challenges in identifying and engaging eligible patient populations.
- Geographically localized, multi-institution strategies may offer a solution to enhance trial participation.
Purpose of the Study:
- To develop and evaluate a geographically localized, multi-institution strategy for improving clinical trial enrollment in secondary stroke prevention.
- To assess the effectiveness of the Local Identification and Outreach Network (LION) compared to conventional recruitment methods.
Main Methods:
- Eleven Connecticut hospitals formed the Local Identification and Outreach Network (LION), identifying stroke/TIA patients from electronic logs.
- A central coordinating center managed patient contact, screening, consent, and follow-up, with researchers traveling statewide.
- Recruitment success was compared between LION sites and other conventional recruitment sites (non-LION) for the Insulin Resistance Intervention after Stroke (IRIS) trial.
Main Results:
- The LION achieved an average monthly randomization rate of 4.0 participants, significantly higher than the 0.46 rate at 104 other IRIS sites.
- LION sites randomized 1.52/1,000 beds/month, compared to 0.76/1,000 beds/month at non-LION sites (p = 0.03).
- The average cost per participant was higher for LION ($8,697) versus non-LION sites ($7,198).
Conclusions:
- A geographically based network with a central coordinating center substantially increased patient randomization rates for secondary stroke prevention trials.
- Multi-institutional surveillance and increased productivity per institution drove the high enrollment rates observed within the LION network.
- While per-patient costs were higher, the network's efficiency in rapid trial completion may lead to overall cost savings in research.
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