Participant characteristics and exclusion from phase 3/4 industry funded trials of chronic medical conditions: meta-analysis of individual participant level data
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
View abstract on PubMed
Summary
This summary is machine-generated.Screen failure in clinical trials was weakly associated with age, sex, comorbidity, and Black race. Increasing screening in underserved populations may improve trial diversity.
Area Of Science
- Clinical trial methodology
- Health disparities research
- Biostatistics
Background
- Clinical trial enrollment faces challenges with participant selection.
- Understanding factors influencing screen failure is crucial for improving trial efficiency and diversity.
- Previous research has not comprehensively analyzed demographic and comorbidity influences on screen failure across diverse trials.
Purpose Of The Study
- To investigate the association between age, sex, comorbidity count, and race/ethnicity with screen failure likelihood in clinical trials.
- To identify demographic and clinical factors that predict exclusion from trial participation.
- To inform strategies for enhancing participant diversity in clinical research.
Main Methods
- Bayesian meta-analysis of individual participant data from 52 industry-funded phase 3/4 chronic condition trials.
- Logistic regression models assessed screen failure odds based on age, sex, comorbidity count, and race/ethnicity.
- Hierarchical models were used to pool trial-level analyses, accounting for between-condition variation.
Main Results
- Weak associations were observed between screen failure and age (OR 1.02 per 10 years), male sex (OR 0.95), and comorbidity count (OR 0.97).
- Individuals identifying as Black showed a slightly higher likelihood of screen failure (OR 1.05) compared to White individuals, persisting after adjustments.
- Between-trial heterogeneity was generally low, with some noted variation by sex across conditions.
Conclusions
- Mostly weak associations exist between screen failure and demographic/clinical factors, including age, sex, comorbidity, and Black race.
- Findings suggest that targeted outreach and screening adjustments for underserved populations may be necessary to improve trial representation.
- Further research is needed to address potential data limitations and confirm these associations.
Contact us if these videos are not relevant.
Contact us if these videos are not relevant.
Related Concept Videos
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Assessing and diagnosing Chronic Obstructive Pulmonary Disease (COPD) involves a detailed approach that includes a comprehensive review of medical history, physical examination, and a variety of diagnostic tests. This thorough evaluation is essential to ensure an accurate diagnosis and guide effective management strategies.
Medical History
• Symptom Review: Chronic symptoms such as persistent cough, sputum production, shortness of breath (dyspnea), and episodes of exacerbation are...
Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...