Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

TLDR

Clinical trial eligibility criteria define the patient population and improve safety, yet they are often too restrictive for cancer trials, limiting enrollment; recent initiatives aim to modernize these criteria. The study aimed to assess current eligibility requirements for cancer clinical trials by reviewing commercial investigational new drug applications submitted to the FDA Office of Hematology and Oncology Products in 2015. The authors discuss potential areas for expanding eligibility criteria and design options for trials incorporating broader inclusion. The study finds that current eligibility criteria narrowly limit participation to lower‑risk patients and that broadening criteria could better reflect real‑world populations, improve participation, and increase access to new treatments.

Abstract

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.