Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands

Objectives The objective of the study was to identify the reasons for discontinuation of clinical drug trials and to evaluate whether efficacy-related discontinuations were adequately planned in the trial protocol. Study Design and Setting All clinical drug trials in the Netherlands, reviewed by institutional review boards in 2007, were followed until December 2015. Data were obtained through the database of the Dutch competent authority (Central Committee on Research Involving Human Subjects [CCMO]) and a questionnaire to the principal investigators. Reasons for trial discontinuation were the... Mehr ...

Verfasser: van den Bogert, Cornelis A.
Souverein, Patrick C.
Brekelmans, Cecile T.M.
Janssen, Susan W.J.
Koëter, Gerard H.
Leufkens, Hubert G.M.
Bouter, Lex M.
Dokumenttyp: Artikel
Erscheinungsdatum: 2017
Reihe/Periodikum: van den Bogert , C A , Souverein , P C , Brekelmans , C T M , Janssen , S W J , Koëter , G H , Leufkens , H G M & Bouter , L M 2017 , ' Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands ' , Journal of Clinical Epidemiology , vol. 88 , pp. 140-147 . https://doi.org/10.1016/j.jclinepi.2017.05.001
Schlagwörter: Clinical Drug Development / Clinical trial / Discontinuation / Futility / Interim analysis / Recruitment failure / /dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being / name=SDG 3 - Good Health and Well-being
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27229658
Datenquelle: BASE; Originalkatalog
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Link(s) : https://research.vu.nl/en/publications/8d94198c-a966-4f9d-a9f1-0c38265c5ad4