Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

Détails

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Etat: Public
Version: Final published version
ID Serval
serval:BIB_94E407E07FDF
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.
Périodique
PloS one
Auteur⸱e⸱s
Blümle A., Schandelmaier S., Oeller P., Kasenda B., Briel M., von Elm E.
Collaborateur⸱rice⸱s
DISCO study group
ISSN
1932-6203 (Electronic)
ISSN-L
1932-6203
Statut éditorial
Publié
Date de publication
2016
Peer-reviewed
Oui
Volume
11
Numéro
10
Pages
e0165605
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: epublish

Résumé
Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear.
To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.
We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.
Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%).
Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

Pubmed
Open Access
Oui
Création de la notice
30/11/2016 17:38
Dernière modification de la notice
20/08/2019 14:57
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