Related Experiment Video
Updated: Jun 16, 2025
00:04
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.6K
Public availability of randomized clinical trial protocols: a repeated meta-research study
Christof Manuel Schönenberger1, Malena Chiaborelli1, Ala Taji Heravi1
1CLEAR-Methods Center, Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Journal of Clinical Epidemiology
|June 13, 2025
Summary
Publicly available randomized clinical trial (RCT) protocols increased to 66% in 2016, driven by industry-sponsored trials. Continued efforts are needed to improve protocol availability, especially for non-industry trials.
Area of Science:
- Medical Research Methodology
- Clinical Trial Transparency
- Evidence-Based Medicine
Background:
- Publicly accessible protocols enhance the trustworthiness and quality of randomized clinical trials (RCTs).
- A prior study found only 36% of RCTs approved in 2012 had publicly available protocols.
- There is a need for updated data on protocol availability and trends over time.
Purpose of the Study:
- To assess the current availability of RCT protocols.
- To evaluate changes in protocol availability since 2012.
- To identify factors associated with protocol availability.
Main Methods:
- A representative sample of RCTs approved in 2016 from Switzerland, Canada, Germany, and the UK were analyzed.
- Searches were conducted in PubMed, Google Scholar, trial registries, and Google for protocols.
- Multivariable logistic regression examined associations between protocol availability and trial characteristics (sample size, intervention type, center status, funding source).
Main Results:
- Overall protocol availability increased to 66% (228/347) for RCTs approved in 2016.
- Protocols were most commonly found on trial registries (43%) or as supplementary material (26%).
- Protocol availability significantly improved for industry-sponsored trials (83.4% in 2016 vs. 34.6% in 2012) but remained low for non-industry trials.
Conclusions:
- Protocol availability in RCTs has improved since 2012, primarily due to industry-sponsored research.
- Industry-sponsored trials showed a substantial increase in protocol availability.
- Further initiatives are necessary to enhance protocol availability, particularly for non-industry sponsored RCTs.
More Related Videos
08:36Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
462
10:38Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
20.2K
Related Concept Videos
01:13Randomized Experiments
6.8K
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
6.8K
01:12Hazard Ratio
103
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
103
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
124
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,...
124
01:11Blinding
2.4K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
2.4K
02:07Blind Procedures
10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.6K
01:20Study Designs in Epidemiology
198
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...
198