Related Experiment Video
Updated: Feb 19, 2026
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
11.3K
Searching for trial protocols: A comparison of methods
Anthea Sutton1, Maria Carmen Galvan De La Cruz1, Joanna Leaviss1
1School of Health and Related Research, The University of Sheffield, Sheffield, UK.
Research Synthesis Methods
|November 1, 2017
Summary
Identifying clinical trial protocols for systematic reviews is crucial. Searching trial registers and contacting authors are effective methods, especially for older trials, ensuring comprehensive data retrieval.
Area of Science:
- Clinical research methodology
- Evidence-based medicine
Background:
- Protocol registration and publication are increasingly vital for funding and publication.
- Access to protocols offers benefits but faces identification challenges.
- Systematic reviews require efficient methods for identifying published trial protocols.
Purpose of the Study:
- To compare different retrieval methods for identifying clinical trial protocols for systematic reviews.
- To evaluate the effectiveness of various search strategies in protocol identification.
Main Methods:
- A systematic search was conducted across six stages: published trial reports, journal websites, internet searches, trial registers, bibliographic databases, and author contact.
- The search aimed to identify 74 clinical trial protocols.
Main Results:
- Completing all six search stages identified 57% of the trial protocols.
- Searching trial registers was the most comprehensive method, identifying 51% of protocols.
- Contacting authors uniquely identified 12% of protocols and was the sole effective method for trials pre-2005.
Conclusions:
- No single method is universally sufficient; a multi-pronged approach is necessary for comprehensive protocol retrieval.
- For trials published post-2005, a strategy involving checking publications, searching registers, and contacting authors is recommended.
- For pre-2005 trials, prioritizing author contact is essential for protocol identification.
Related Concept Videos
01:16Clinical Trials
10.9K
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...
10.9K
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
242
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...
242
01:11Clinical Trials: Overview
5.1K
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...
5.1K
01:16Crossover Experiments
4.6K
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
4.6K
01:20Comparing the Survival Analysis of Two or More Groups
636
Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and...
636
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
273
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...
273