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Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives
Patrick M Forde1, Phil Bonomi2, Alice Shaw3
1Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University, Baltimore, MD.
Abstract:
Low rates of adult patient participation have been a persistent problem in cancer clinical trials and have continued to be a barrier to efficient drug development. The routine use of significant exclusion criteria has contributed to this problem by limiting participation in studies and creating significant clinical differences between the study cohorts and the real-world cancer patient populations. These routine exclusions also unnecessarily restrict opportunities for many patients to access potentially promising new therapies during clinical development. Multiple efforts are underway to broaden eligibility criteria, allowing more patients to enroll in studies and generating more robust data regarding the effect of novel therapies in the population at large. Focusing specifically on lung cancer as an example, a multistakeholder working group empaneled by the LUNGevity Foundation identified 14 restrictive and potentially outdated exclusion criteria that appear frequently in lung cancer clinical trials. As a part of the project, the group evaluated data from multiple recent lung cancer studies to ascertain the extent to which these 14 criteria appeared in study protocols and played a role in excluding patients (screen failures). The present report describes the working group's efforts to limit the use of these routine exclusions and presents clinical justifications for reducing the use of 14 criteria as routine exclusions in lung cancer studies, potentially expanding trial eligibility and improving the generalizability of the results from lung cancer trials.
Insights
Patient participation in cancer clinical trials is low due to strict exclusion criteria. This study identifies 14 common lung cancer trial exclusions that could be revised to improve patient access and trial generalizability.
Area of Science:
- Oncology
- Clinical Trial Design
- Drug Development
Background:
- Low adult patient participation in cancer clinical trials hinders drug development.
- Restrictive exclusion criteria limit trial enrollment and create disparities between study populations and real-world patients.
- These exclusions also restrict patient access to novel therapies.
Purpose of the Study:
- To identify and evaluate restrictive exclusion criteria in lung cancer clinical trials.
- To provide clinical justifications for reducing the use of these criteria.
- To expand trial eligibility and improve the generalizability of lung cancer trial results.
Main Methods:
- A multistakeholder working group, convened by the LUNGevity Foundation, focused on lung cancer.
- Identified 14 frequently used, restrictive exclusion criteria in lung cancer trials.
- Evaluated data from recent lung cancer studies to assess the impact of these criteria on patient exclusion (screen failures).
Main Results:
- 14 restrictive and potentially outdated exclusion criteria were identified in lung cancer trials.
- Analysis revealed the extent to which these criteria appear in protocols and lead to screen failures.
- Clinical justifications for reducing the routine use of these 14 criteria were developed.
Conclusions:
- Reducing routine exclusions in lung cancer trials can broaden eligibility.
- Expanding trial access can improve the generalizability of findings to the broader patient population.
- Revising exclusion criteria supports more efficient drug development and equitable patient access to novel treatments.
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