Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study.
BMJ Open
; 5(7): e007827, 2015 Jul 07.
Article
em En
| MEDLINE
| ID: mdl-26152325
ABSTRACT
INTRODUCTION:
Responsible conduct of research implies that results of clinical trials should be completely and adequately reported. This article describes the design of a cohort study that aims to investigate the occurrence and the determinants of selective reporting in an inception cohort of all clinical drug trials that were reviewed by the Dutch Institutional Review Boards (IRBs) in 2007. It also describes the characteristics of the study cohort. METHODS ANDANALYSIS:
In 2007, Dutch IRBs reviewed 622 clinical drug trials. For each trial, we assessed the stages of progress. We discriminated five intermediate stages and five definite stages. Intermediate stages of progress are approved by an IRB; started inclusion; completed as planned; terminated early; published as article. The definite stages of progress are rejected by an IRB; never started inclusion; not published as article; completely reported; selectively reported. We will use univariate and multivariate Cox regression models to identify trial characteristics associated with non-publication. We will identify seven trial-specific discrepancy items, including the objectives, inclusion and exclusion criteria, end points, sample size, additional analyses, type of population analysis and sponsor acknowledgement. The percentage of trials with discrepancies between the protocol and the publication will be scored. We will investigate the association between trial characteristics and the occurrence of discrepancies. ETHICS AND DISSEMINATION No IRB-approval is required for this study. Access to confidential research protocols was provided by the Central Committee on Research Involving Human Subjects. We plan to finish data collection in June 2015, and expect to complete data cleaning, analysis and manuscript preparation within the next 3â months. Hence, a first draft of an article containing the results is expected before the end of October 2015.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Preparações Farmacêuticas
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Ensaios Clínicos como Assunto
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article