Related Experiment Video
Updated: Mar 28, 2026
07:48
Eye Tracking During A Complex Aviation Task For Insights Into Information Processing
Published on: April 4, 2025
1.5K
Key Features of Contemporary Pilot and Feasibility Trials: Protocol for a Methodological Study
Aske Tøgern1, Morten H Møller1,2, Anders Perner1,2
1Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Acta Anaesthesiologica Scandinavica
|March 27, 2026
Summary
This study analyzes pilot randomized clinical trials (RCTs) in hospitalized patients to understand feasibility assessment methods. Improving pilot RCT design and reporting can reduce research waste and enhance future trial value.
Area of Science:
- Clinical Trials Methodology
- Health Services Research
- Medical Research Design
Background:
- Randomized clinical trials (RCTs) are resource-intensive, with failures in recruitment, group separation, and follow-up leading to research waste.
- Pilot RCTs are crucial for assessing the viability of definitive trials, including recruitment, protocol adherence, and data collection.
- Enhanced attention to the design, conduct, and reporting of pilot RCTs is necessary to maximize their value.
Purpose of the Study:
- To describe and characterize the feasibility assessment methodology used in contemporary pilot RCTs involving hospitalized patients.
- To identify common practices and variations in how feasibility is assessed in pilot trials across different medical and surgical specialties.
Main Methods:
- A methodological study involving a systematic search for pilot/feasibility RCTs published within a recent timeframe (initially 6 months, expandable to 5 years).
- Data extraction on key trial characteristics, feasibility assessment areas, methodology (e.g., pre-defined outcomes, progression criteria), and plans for definitive trials.
- Descriptive statistical analysis of extracted data, stratified by intervention type, area of care, and comparator type.
Main Results:
- The study will provide data on the key features of current pilot RCTs in hospitalized patients.
- It will detail the specific feasibility assessment methodologies employed in these trials.
- Findings will be summarized using descriptive statistics, offering insights into the landscape of pilot trial conduct.
Conclusions:
- The findings will illuminate the methodologies used for feasibility assessment in contemporary pilot RCTs.
- This knowledge can inform improvements in the design, conduct, and reporting of future pilot RCTs.
- Ultimately, enhancing pilot RCTs will increase their value and contribute to reducing overall research waste.
More Related Videos
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
529
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,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
529
01:16Clinical Trials
11.1K
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...
11.1K
01:20Study Designs in Epidemiology
1.5K
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
1.5K
01:11Clinical Trials: Overview
5.4K
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...
5.4K
01:15Study Design in Statistics
10.3K
A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
10.3K
01:16Experimental Designs
18.5K
An experimental design is a systematic process that allows researchers to evaluate the relationship between dependent and independent variables. There are three widely used types of experimental design - pre-experimental design, true experimental design, and quasi-experimental design. In pre-experimental design, the researcher compares the data before and after some interventions or treatments. The true-experimental design has more than one purposefully created group, a commonly measured...
18.5K