A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-11-26

AUTHORS

Stuart A Bell, Catrin Tudur Smith

ABSTRACT

ObjectivesTo provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases.DesignRegistry based study of ClinicalTrials.gov registration entries.MethodsThe ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,088 Interventional trials registered after January 1, 2006, conducted in the United States, Canada and/or the European Union were categorised as rare or non-rare. Characteristics of the respective trials were extracted and summarised with comparative statistics calculated where appropriate.Main outcome measuresCharacteristics of interventional trials reported in the database categorised by rare and non-rare conditions to allow comparison.ResultsOf the 24,088 trials categorised 2,759 (11.5%) were classified as rare disease trials and 21,329 (88.5%) related to non-rare conditions. Despite the limitations of the database we found that rare disease trials differed to non-rare disease trials across all characteristics that we examined. Rare disease trials enrolled fewer participants (median 29 vs. 62), were more likely to be single arm (63.0% vs. 29.6%), non-randomised (64.5% vs. 36.1%) and open label (78.7% vs. 52.2%). A higher proportion of rare disease trials were terminated early (13.7% vs. 6.3%) and proportionally fewer rare disease studies were actively pursuing, or waiting to commence, enrolment (15.9% vs. 38.5%).ConclusionRare disease interventional trials differ from those in non-rare conditions with notable differences in enrolment, design, blinding and randomisation. However, clinical trials should aim to implement the highest trial design standards possible, regardless of whether diseases are rare or not. More... »

PAGES

170

References to SciGraph publications

  • 2008-05-02. Adaptive design methods in clinical trials – a review in ORPHANET JOURNAL OF RARE DISEASES
  • 2012-10-17. Drug Labels: A Flawed Source of Data for Studying Orphan Drug Approvals in CLINICAL PHARMACOLOGY & THERAPEUTICS
  • 2013-03-25. Experimental designs for small randomised clinical trials: an algorithm for choice in ORPHANET JOURNAL OF RARE DISEASES
  • 2012-06-27. Raising Orphans: How Clinical Development Programs of Drugs for Rare and Common Diseases Are Different in CLINICAL PHARMACOLOGY & THERAPEUTICS
  • 2012-10-23. Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU in EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
  • 2010-11-09. Rare diseases, orphan drugs and their regulation: questions and misconceptions in NATURE REVIEWS DRUG DISCOVERY
  • 2013-10-16. Clinical evidence for orphan medicinal products-a cause for concern? in ORPHANET JOURNAL OF RARE DISEASES
  • 2010-08-20. Evidence-Based Medicine and Rare Diseases in RARE DISEASES EPIDEMIOLOGY
  • 2010-08-20. Clinical Trials and Rare Diseases in RARE DISEASES EPIDEMIOLOGY
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    URI

    http://scigraph.springernature.com/pub.10.1186/s13023-014-0170-0

    DOI

    http://dx.doi.org/10.1186/s13023-014-0170-0

    DIMENSIONS

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/25427578


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