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

Hypothesis and hypothesis testing in the clinical trial.

J A Lieberman1

  • 1Department of Psychiatry and Mental Health and Neuroscience Clinical Research Center, University of North Carolina School of Medicine, Chapel Hill 27599-7160, USA.

The Journal of Clinical Psychiatry
|May 31, 2001
PubMed
Summary

Clinical trial hypotheses guide research and outcome evaluation. This study reviews how five atypical antipsychotic trials reported their hypotheses and statistical methods, finding inconsistencies.

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

Hippocampal dysfunction in the pathophysiology of schizophrenia: a selective review and hypothesis for early detection and intervention.

Molecular psychiatry·2018
Same author

Baseline demographics, clinical features and predictors of conversion among 200 individuals in a longitudinal prospective psychosis-risk cohort.

Psychological medicine·2017
Same author

Probable metronidazole induced serum sickness-like reaction in a paediatric patient.

Journal of clinical pharmacy and therapeutics·2016
Same author

The role of the ITIH3 rs2535629 variant in antipsychotic response.

Schizophrenia research·2016
Same author

Genome-wide association study on antipsychotic-induced weight gain in the CATIE sample.

The pharmacogenomics journal·2015
Same author

Methylenetetrahydrofolate reductase gene variants and antipsychotic-induced weight gain and metabolic disturbances.

Journal of psychiatric research·2014

Area of Science:

  • Clinical Research Methodology
  • Psychopharmacology

Background:

  • Hypotheses are fundamental to clinical trials, dictating research direction and outcome assessment.
  • Hypothesis testing, using metrics like p values, is crucial for determining trial success.
  • Inconsistent reporting of hypotheses and statistical data in clinical trial publications is a recognized issue.

Purpose of the Study:

  • To evaluate the reporting of hypotheses and statistical testing in five recent clinical trials of atypical antipsychotics.
  • To identify common practices and potential deficiencies in hypothesis and statistical reporting within this therapeutic area.

Main Methods:

  • Systematic review of five published clinical trials comparing atypical antipsychotics.
  • Analysis of how each study explicitly stated its primary hypothesis.

Related Experiment Videos

  • Examination of the statistical methods and significance levels (e.g., p values, alpha levels) reported for outcome evaluation.

    • Main Results:

    • Variability observed in the explicit statement of hypotheses across the reviewed studies.
    • Inconsistent reporting of statistical thresholds and detailed hypothesis testing procedures.
    • Potential for ambiguity in interpreting trial outcomes due to incomplete reporting.

    Conclusions:

    • There is a need for clearer and more standardized reporting of hypotheses and statistical testing in clinical trials.
    • Improved reporting practices will enhance the transparency and reproducibility of clinical trial findings.
    • Exploring alternative hypothesis testing frameworks may offer more robust outcome evaluation.