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 t... 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
Schlagwörter: Clinical Trials Data Monitoring Committees / Clinical Trials as Topic / Cohort Studies / Early Termination of Clinical Trials / Humans / Netherlands / Patient Selection / Pharmaceutical Preparations / Sample Size / Journal Article / Taverne
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-26835586
Datenquelle: BASE; Originalkatalog
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Link(s) : https://dspace.library.uu.nl/handle/1874/361889