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

Randomized versus historical controls for clinical trials

H Sacks, T C Chalmers, H Smith

    The American Journal of Medicine
    |February 1, 1982
    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

    Secondary arteriosclerosis of pulmonary arteries with thrombosis.

    The Quarterly bulletin of the Indiana University Medical Center·2010
    Same author

    Utility of QuantiFERON-TB Gold in-tube testing for latent TB infection in HIV-infected individuals.

    The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease·2007
    Same author

    Toxicity and efficacy of daily vs. weekly dapsone for prevention of Pneumocystis carinii pneumonia in children infected with human immunodeficiency virus. ACTG 179 Study Team. AIDS Clinical Trials Group.

    The Pediatric infectious disease journal·1999
    Same author

    The Women's Interagency HIV Study. WIHS Collaborative Study Group.

    Epidemiology (Cambridge, Mass.)·1998
    Same author

    Depression and primary care.

    Annals of internal medicine·1997
    Same author

    Concentrations of soluble CD95 and CD8 antigens in the plasma and levels of CD8+CD95+, CD8+CD38+, and CD4+CD95+ T cells are markers for HIV-1 infection and clinical status.

    Journal of clinical immunology·1997
    Same journal

    Mineralocorticoid Antagonists for Post-MI HFpEF: Plausible Biology Meets Low Residual Risk?

    The American journal of medicine·2026
    Same journal

    GLP-1 Receptor Agonists and Age-related Macular Degeneration Risk in Diabetes or Non-diabetic Obesity: A Retrospective Cohort Study.

    The American journal of medicine·2026
    Same journal

    Marijuana Use and Acute Myocardial Infarction: Mechanistic Insights, Clinical Implications, and Emerging Challenges.

    The American journal of medicine·2026
    Same journal

    Cave Canem - Beware of the Dog.

    The American journal of medicine·2026
    Same journal

    Risk Factors for 30-day Hospital Readmission After Hospital-at-Home Treatment of Acute Pyelonephritis.

    The American journal of medicine·2026
    Same journal

    Mesenteric panniculitis.

    The American journal of medicine·2026
    See all related articles

    Historical controls (HCTs) in clinical trials often show positive results due to patient selection bias, unlike randomized controlled trials (RCTs). This comparison highlights the need for robust trial designs to ensure reliable treatment effect evaluation.

    Area of Science:

    • Clinical Trials Methodology
    • Evidence-Based Medicine
    • Biostatistics

    Background:

    • Randomized controlled trials (RCTs) are the gold standard for clinical research.
    • Historical controls (HCTs) are sometimes used as an alternative, but their validity is debated.

    Purpose of the Study:

    • To compare the efficacy of therapies evaluated using both randomized controls (RCTs) and historical controls (HCTs).
    • To identify potential biases and limitations associated with each control group methodology.

    Main Methods:

    • Literature search for therapies studied by both RCTs and HCTs.
    • Analysis of reported trial outcomes and control group performance.
    • Adjustment for prognostic factors in HCTs where possible.

    Related Experiment Videos

    Main Results:

    • 79% of HCTs found the therapy superior, compared to only 20% of RCTs for the same therapies.
    • Discrepancies were primarily due to worse outcomes in HCT control groups versus RCT control groups.
    • Adjusting for prognostic factors did not resolve the observed differences.

    Conclusions:

    • HCTs may be biased in favor of new therapies due to patient selection issues.
    • RCTs might overlook significant benefits if sample sizes are inadequate.
    • Improving trial validity may involve reconsidering significance levels (p<0.05) and utilizing confidence intervals.