Related Experiment Video
Updated: Oct 15, 2025
Performing Data Mining And Integrative Analysis Of Biomarker in Breast Cancer Using Multiple Publicly Accessible Databases
Published on: May 17, 2019
Exclusion criteria of breast cancer clinical trial protocols: a descriptive analysis
Clara Wan1, Nicole E Caston1, Stacey A Ingram1
1University of Alabama at Birmingham, WTI 240E, Birmingham, AL, 35294, USA.
Purpose:
3-8% of US adults with cancer are enrolled in a clinical trial due to various barriers to enrollment. The purpose of this study is to evaluate the variability of eligibility criteria, which currently have no standard guidelines.
Methods:
This descriptive analysis utilized all therapeutic breast protocols offered at the University of Alabama at Birmingham between 2004 and 2020. Exclusion criteria were abstracted using OnCore and ClinicalTrials.gov. Laboratory values included liver function tests and hematologic labs. Comorbid conditions included congestive heart failure, cardiovascular disease, central nervous system (CNS) metastases, and prior cancer history. Comorbid conditions were further analyzed by amount of time protocols required participants to be from diagnosis or exacerbation-free.
Results:
102 protocols were eligible. Among liver laboratory values, bilirubin (78%) was included in most protocols ranging from institutional upper limit of normal (ULN) (9%) to 3xULN (2%), with 1.5xULN (56%) being most common. Similar variability was observed in alanine transaminase and aspartate transaminase. Among hematological labs, 82% of protocols defined a lower limit of acceptable absolute neutrophil count ranging from 500 μL (1%) to 1800 μL (1%), with 1500 μL (64%) being most common. Of the comorbid conditions, exclusion criteria varied for congestive heart failure (49%), an acute exacerbation of cardiovascular disease (80%), CNS metastases (59%), and a prior cancer (66%). The allowable timeframe varied between protocols for cardiovascular disease and prior cancer.
Conclusion:
Substantial heterogeneity was observed across laboratory values and comorbid variables among protocols. Future research should focus on defining standardized eligibility criteria while allowing for deviation based on drug specificity.
Insights
Cancer clinical trial eligibility criteria vary widely, impacting patient enrollment. This study highlights significant heterogeneity in lab values and comorbidities, suggesting a need for standardized guidelines.
Area of Science:
- Oncology
- Clinical Trial Design
- Biostatistics
Background:
- Limited clinical trial enrollment (3-8% of US cancer patients) is a significant challenge.
- Existing eligibility criteria lack standardized guidelines, contributing to enrollment barriers.
Purpose of the Study:
- To evaluate the variability of eligibility criteria in therapeutic breast cancer protocols.
- To identify specific areas of heterogeneity in laboratory values and comorbid conditions.
Main Methods:
- Descriptive analysis of 102 therapeutic breast cancer protocols (2004-2020) at the University of Alabama at Birmingham.
- Abstraction of exclusion criteria, including laboratory values (liver function, hematologic) and comorbid conditions (heart failure, cardiovascular disease, CNS metastases, prior cancer).
- Analysis of timeframes required for comorbidity-free status.
Main Results:
- Significant variability observed in inclusion/exclusion criteria for laboratory values (e.g., bilirubin, AST, ALT) and hematologic labs (e.g., absolute neutrophil count).
- Wide ranges in exclusion criteria for comorbid conditions like congestive heart failure (49%), cardiovascular disease exacerbation (80%), CNS metastases (59%), and prior cancer (66%).
- Inconsistent timeframes for comorbidity-free status across protocols.
Conclusions:
- Substantial heterogeneity exists in clinical trial eligibility criteria for laboratory values and comorbid conditions.
- Development of standardized eligibility criteria is recommended, with flexibility for drug-specific requirements.
- Addressing this variability may improve clinical trial accessibility and patient enrollment.
More Related Videos
Related Concept Videos
01:21Cancer Survival Analysis
01:11Clinical Trials: Overview
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:09Truncation in Survival Analysis
Left truncation occurs when individuals who experienced the event of interest before a certain time are not included in the study. This is often due to a "delayed entry" into the study where only those who survive until a certain entry point are...
01:12Hazard Ratio
For example, in a clinical trial...