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Related Concept Videos

Hazard Ratio01:12

Hazard Ratio

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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...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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,...
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Randomized Experiments01:13

Randomized Experiments

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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...
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Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

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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...
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Odds Ratio01:09

Odds Ratio

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The odds ratio (OR) is a statistical measure used extensively in epidemiology and research to quantify the strength of association between exposure and outcome across different groups. Unlike relative risk, which compares the probabilities of an event occurring, the odds ratio compares the odds of an event occurring in the exposed group to the odds of it occurring in the unexposed group. The odds, in this context, are calculated as the probability of the event happening divided by the...
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Testing a Claim about Population Proportion01:24

Testing a Claim about Population Proportion

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A complete procedure for testing a claim about a population proportion is provided here.
There are two methods of testing a claim about a population proportion: (1) Using the sample proportion from the data where a binomial distribution is approximated to the normal distribution and (2) Using the binomial probabilities calculated from the data.
The first method uses normal distribution as an approximation to the binomial distribution. The requirements are as follows: sample size is large...
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Related Experiment Video

Updated: May 29, 2025

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Protocol publication rate and comparison between article, registry and protocol in RCTs.

Sylvain Mathieu1,2,3, Jean-Baptiste Bouillon-Minois4, Laurent Renard Triché5,6,7

  • 1Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France. smathieu@chu-clermontferrand.fr.

BMC Medical Research Methodology
|February 1, 2025
PubMed
Summary

Publishing clinical trial protocols does not significantly improve consistency in primary outcomes and sample sizes compared to registration alone. Trial registration is sufficient for ensuring data integrity and transparency in research.

Keywords:
Protocol publicationRCTRegistration

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Area of Science:

  • Clinical Research Methodology
  • Evidence-Based Medicine
  • Scientific Transparency

Background:

  • Ensuring transparency in clinical research is vital to prevent misleading findings.
  • Mandatory clinical trial registration is in place, but protocol publication's impact on outcomes and sample sizes is unclear.
  • This study investigates protocol publication rates and consistency of primary outcomes and sample sizes in randomized controlled trials.

Purpose of the Study:

  • To determine the rates of trial protocol publication and registration for randomized controlled trials (RCTs).
  • To compare the consistency of primary outcomes (PO) and sample sizes (SS) between published protocols, registered trials, and published articles.
  • To assess the added value of protocol publication beyond trial registration for transparency.

Main Methods:

  • A literature search was conducted on MEDLINE via PubMed for RCT reports.
  • Data extraction focused on trial registration, protocol publication, and comparisons of PO and SS.
  • Analysis compared information across published articles, trial registries, and publicly available protocols.

Main Results:

  • Of 589 RCTs analyzed, 24.8% had published protocols, with 42.4% of these published before trial completion.
  • 89.6% of RCTs were registered, with 44% registered before study commencement.
  • No significant differences were found in PO and SS between published protocols and articles, or between articles and registries.
  • Journals with higher impact factors or generalist scope showed higher rates of protocol publication and registration, and greater consistency in PO and SS.

Conclusions:

  • Trial registration alone appears sufficient for maintaining consistency in primary outcomes and sample sizes.
  • While protocol publication may enhance transparency in peer review, it offers no significant additional benefits for outcome reporting consistency.
  • Focusing on robust trial registration practices is key for ensuring research integrity.