Related Experiment Video
Updated: Dec 6, 2025
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
11.0K
Fair and equitable subject selection in concurrent COVID-19 clinical trials
Maud O Jansen1, Peter Angelos2, Stephen J Schrantz1
1Medicine, University of Chicago, Chicago, Illinois, USA.
Journal of Medical Ethics
|October 13, 2020
Summary
Ensuring fair subject selection in concurrent COVID-19 clinical trials is crucial. This study proposes new ethical guidelines to address inequities arising from scientific uncertainty and structural barriers, promoting equitable access to investigational therapies.
Area of Science:
- Clinical Research Ethics
- Public Health Policy
- Infectious Disease Epidemiology
Background:
- The COVID-19 pandemic necessitated rapid clinical trial development for life-saving therapies.
- Fair and equitable subject selection is a critical ethical concern, influencing risk/benefit distribution and generalizability of results.
- Existing oversight by Research Ethics Committees is limited to individual trials, lacking cross-trial standardization for subject selection.
Purpose of the Study:
- To investigate potential unfair and inequitable subject selection across concurrent clinical trials for COVID-19.
- To identify factors contributing to selection inequities, including scientific uncertainty, lack of transparency, resource scarcity, and structural barriers.
- To propose novel ethical guidelines for research design and conduct to enhance fair subject selection in multi-trial settings.
Main Methods:
- Analysis of subject selection experiences from multiple concurrent COVID-19 clinical trials at a single academic medical center.
- Qualitative assessment of factors influencing subject recruitment and enrollment.
- Development of ethical guidelines based on identified challenges and best practices.
Main Results:
- Concurrent COVID-19 trials are susceptible to unfair and inequitable subject selection.
- Key contributing factors include scientific uncertainty, limited transparency, resource scarcity, and systemic inequities compounded by implicit bias.
- A critical gap exists in current literature and international regulations regarding cross-trial subject selection oversight.
Conclusions:
- New ethical guidelines are proposed to bolster fair and equitable subject selection in clinical trial research.
- These guidelines aim to address the identified shortcomings in concurrent trial designs and conduct.
- The proposed framework, tailored for COVID-19 trials, may offer broader applicability to other single or multi-trial research scenarios.
More Related Videos
Related Concept Videos
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
69
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
69
01:11Clinical Trials: Overview
4.4K
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...
4.4K
01:16Clinical Trials
10.0K
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...
There are four phases in a clinical trial. A phase one...
10.0K
01:13Bioequivalence studies: Biowaivers
107
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
107
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
124
Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
124
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
90
Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
90