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

Detecting selection bias in randomized clinical trials.

V W Berger1, D V Exner

  • 1Food and Drug Administration, Rockville, Maryland 20852-1448, USA. BERGERV@CBER.FDA.GOV

Controlled Clinical Trials
|August 10, 1999
PubMed
Summary
This summary is machine-generated.

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

Quality of research: Improper evaluation of the quality of trials of retention rates.

British dental journal·2019
Same author

The role of the randomised controlled trial in restorative dentistry and the correct purpose of observational data.

British dental journal·2019
Same author

Failure to look beyond blocks is a mistake.

Methods of information in medicine·2015
Same author

Vitamin D supplementation is associated with improved modulation of cardiac autonomic tone in healthy humans.

International journal of cardiology·2014
Same author

Spin and bias: the tip of the iceberg.

Annals of oncology : official journal of the European Society for Medical Oncology·2013
Same author

Impact of gender on the cardiac autonomic response to angiotensin II in healthy humans.

Journal of applied physiology (Bethesda, Md. : 1985)·2012
Same journal

On the generation and ownership of alpha in medical studies.

Controlled clinical trials·2004
Same journal

An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia.

Controlled clinical trials·2004
Same journal

Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture.

Controlled clinical trials·2004
Same journal

Statistical comparison of random allocation methods in cancer clinical trials.

Controlled clinical trials·2004
Same journal

Analyzing bronchodilation with emphasis on disease type, age and sex.

Controlled clinical trials·2004
Same journal

Geographic variability in patient characteristics, treatment and outcome in an International Trial of Magnesium in acute myocardial infarction.

Controlled clinical trials·2004
See all related articles

Selection bias in clinical trials compromises validity. A new method using only response data detects this bias, even when baseline comparisons fail.

Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Evidence-Based Medicine

Background:

  • Lack of allocation concealment in randomized clinical trials can introduce selection bias.
  • Selection bias, the preferential enrollment of patients into treatment groups, compromises trial validity.
  • Existing methods for detecting selection bias, such as baseline characteristic comparisons, have limitations.

Purpose of the Study:

  • To develop a novel method for detecting selection bias using only patient response data.
  • To address situations where allocation concealment is compromised due to small block sizes or open-label designs.
  • To provide a sensitive tool that complements traditional baseline comparisons.

Main Methods:

  • Developed a new statistical method based exclusively on treatment response data.

Related Experiment Videos

  • The method is designed for scenarios with compromised allocation concealment.
  • Evaluated the sensitivity of the new method in detecting selection bias.

    • Main Results:

    • The proposed method effectively detects selection bias using response data alone.
    • This approach is sensitive even when traditional baseline comparisons are inadequate.
    • The new method offers a valuable addition to existing bias detection techniques.

    Conclusions:

    • A novel, response-data-only method can reliably detect selection bias in clinical trials.
    • This method is particularly useful when allocation concealment is compromised.
    • The findings enhance the robustness of clinical trial evidence by improving bias detection.