June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Discontinuation and Nonpublication of Interventional Clinical Trials Conducted in Uveitis Patients
Author Affiliations & Notes
  • Taygan Yilmaz
    Ophthalmology, Warren Alpert Medical School at Brown University, Providence, Rhode Island, United States
  • Miguel Cordero-Coma
    Ophthalmology, Uveitis Unit, University Hospital of León, Leon, Spain
    Instituto de Biomedicina (IBIOMED), Leon, Spain
  • Michael E Migliori
    Ophthalmology, Warren Alpert Medical School at Brown University, Providence, Rhode Island, United States
  • Footnotes
    Commercial Relationships   Taygan Yilmaz, None; Miguel Cordero-Coma, None; Michael Migliori, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2186. doi:
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      Taygan Yilmaz, Miguel Cordero-Coma, Michael E Migliori; Discontinuation and Nonpublication of Interventional Clinical Trials Conducted in Uveitis Patients. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2186.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Discontinuation of interventional clinical trials and nonpublication of completed trials represent a waste of already scarce resources. They also contribute to publication bias and, by being censored from the medical literature, diminish the quality of the overall body of evidence. We sought to identify the prevalence of discontinuation and nonpublication of interventional clinical trials conducted in uveitis patients.

Methods : We conducted a retrospective, cross-sectional study of uveitis-based interventional clinical trials in ClinicalTrials.gov dating back to 1990. Data were collected from the registry and associated publications were identified (final search on December 5, 2016).

Results : Of 115 trials, 32 (28%) were discontinued early with only four of these studies being published. This represents a considerable number of participants who accepted the potential risks and inconveniences of taking part in a clinical trial but whose contribution ultimately played no role in the advancement of medical evidence. Half of the trials had unclear or no reported reasons for trial discontinuation. The odds of discontinuation were greater among industry-sponsored trials than among academic-sponsored trials (odds ratio [OR] 2.75, 95% confidence interval [CI] 0.84–9.01). Of the 83 completed trials, 62 (75%) were not published, representing approximately 218 participants. Only eight unpublished trials posted results on ClinicalTrials.gov. Trials funded by industry were more than three times as likely as trials funded by academic centers to result in nonpublication (OR 3.73, 95% CI 1.12–12.38).

Conclusions : The non-publication of many completed trials, and of preliminary results of trials that are discontinued early, dilutes the quality and decreases the comprehensive nature of the medical literature. This occurs in both industry and academic-sponsored trials though the odds of discontinuation and non-publication are greater among industry-sponsored trials. Greater transparency through the publication of clinical trials with negative results as well as those that are terminated early could minimize publication bias and thus lead to a more robust medical literature.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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