NCT06314542

Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria for Lung Cancer Based on Real-world Data

Quantitative Evaluation of the Impact of Relaxing Eligibility Criteria on the Risk-benefit Profile of Drugs for Lung Cancer Based on Real-world Data

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

Eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. In order to evaluate the REC of NSCLC drug trials, this study will use deep learning methods to construct a structured real-world database of NSCLC across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety.

Detailed description

Restrictive eligibility criteria in cancer drug trials result in low enrollment rates and limited population diversity. Relaxed eligibility criteria (REC) based on solid evidence is becoming necessary for stakeholders worldwide. However, the absence of high-quality, favorable evidence remains a major challenge. This study presents a protocol to quantitatively evaluate the impact of relaxing eligibility criteria in common non-small cell lung cancer (NSCLC) protocols in China, on the risk-benefit profile. This involves a detailed explanation of the rationale, framework, and design of REC. To evaluate our REC in NSCLC drug trials, we will first construct a structured, cross-dimensional real-world NSCLC database using deep learning methods. We will then establish randomized virtual cohorts and perform benefit-risk assessment using Monte Carlo simulation and propensity matching. Shapley value will be utilized to quantitatively measure the effect of the change of each eligibility criterion on patient volume, clinical efficacy and safety.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	relaxing eligibility criteria	Quantitative evaluation of the impact of relaxing eligibility criteria on the risk-benefit profile of drugs for lung cancer based on real-world data

Timeline

• Start date: 2013-01-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: China