Outcomes publication of rheumatology clinical trials completed over a ten-year period

• Autores: Cristina Mondelo García, Marta Calvín Lamas, María Teresa Rabuñal Álvarez, Francisco J. Blanco García, Isabel Martín Herranz
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 18, Nº. 4, 2016, págs. 232-238
• Idioma: inglés
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• Resumen

  • Background: For the past twenty years there have been many legislative changes in order to decrease the lack of transparency in Clinical Trials (CT) registration as well as the selective publication of results or even their non-publication.

    Purpose: To verify outcomes publication of CT carried out by the Rheumatology Service (RS) and finished in a period of ten years,journal of publication and the Impact Factor (IF) of the journal in the corresponding year.

    Methods: Prevalence observational study carried out in a tertiary level university hospital, with retrospective data collection of 100% CT carried out by the RS and finished between 2001-2010. Data sources: CTs' management computer application of pharmacy service, and PubMed. Searching strategy: 1st To verify register and outcomes availability at using protocol number, and to search publications in PubMed with NCT. 2nd Search in PubMed by investigational drug, pathology and/or sponsor. Among CT published in scientific journals, time until publication was collected as well as Impact Factor (IF).

    Results: Between 2001-2010 RS carried out 62 CT, 36 finished in this period. 10/36 were not registered at (finished between 2001-2005). In 16/26 CT registered, outcomes are not available at , and 11 of them (11/16) are published in journals (IF range: 0-30.758). In 10/26 CT with outcomes available in , 6 CT are published in journals (IF range: 0-16.104). Ann Rheum Dis was the journal with more publications (5/16). Average time until publication was 2.5 years. Globally, in 58.3% CT outcomes are available.

    Conclusions: Our study shows an increase of CT registered after the ICMJE initiative in 2005 (18.2% vs. 96%), all trials registered before patients inclusion, critical point in clinical research transparence. An increase of trials with outcomes at after the requirement of FDA in 2007 was showed (16.7% before vs. 45% after 2007)