Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

When can a clinical trial be called 'randomized'?

Vance W Berger1, Jeffrey D Bears

  • 1National Cancer Institute, EPN, Suite 3131, 6130 Executive Boulevard, MSC-7354, Bethesda, MD 20892-7354, USA.

Vaccine
|January 18, 2003
PubMed
Summary

Randomized clinical trials are the gold standard for evaluating medical interventions. This review clarifies what defines a truly randomized study to ensure accurate credibility and influence on medical practice.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

A methodological assessment of randomization integrity in alteplase for acute ischemic stroke individual patient data meta-analyses.

PloS one·2025
Same author

The fundamentals of multiplicity adjustment in biostatistics.

Journal of the National Cancer Institute. Monographs·2025
Same author

Steady-state statistical properties and implementation of randomization designs with maximum tolerated imbalance restriction for two-arm equal allocation clinical trials.

Statistics in medicine·2024
Same author

On "Re-randomization tests as sensitivity analyses to confirm immunological noninferiority of an investigational vaccine: Case study" by Luca Grassano et al. (2023, Pharmaceutical Statistics).

Pharmaceutical statistics·2024
Same author

A roadmap to using randomization in clinical trials.

BMC medical research methodology·2021
Same author

Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials.

Clinical trials (London, England)·2018

Area of Science:

  • Clinical Trials Methodology
  • Medical Research Integrity
  • Evidence-Based Medicine

Background:

  • Randomized clinical trials (RCTs) are the benchmark for evaluating medical interventions due to their ability to balance characteristics and enable inference.
  • The integrity of medical research relies on accurate study design and reporting.
  • Mislabeling non-randomized studies as randomized can lead to undue credibility and impact clinical practice.

Purpose of the Study:

  • To review the benefits conferred by randomization in clinical trials.
  • To examine the specific aspects of randomization that provide these benefits.
  • To clarify the definition and criteria for a study to be considered truly randomized.

Main Methods:

  • Literature review of established principles of randomization in clinical trials.
  • Analysis of the methodological advantages of randomization.
  • Discussion of criteria for identifying genuine randomized studies.

Main Results:

  • Randomization balances measured and unmeasured baseline characteristics, reducing bias.
  • Randomization facilitates blinding (masking) of participants and researchers.
  • Randomization provides a robust foundation for statistical inference and generalizability.

Conclusions:

  • Understanding the core principles of randomization is crucial for evaluating study validity.
  • Accurate identification of randomized studies is essential for maintaining the credibility of medical evidence.
  • Ensuring studies are genuinely randomized protects against the unwarranted influence of flawed research on medical practice.

Related Experiment Videos