Progress of the ALIFE2 study: A dynamic road towards more evidence

Investigator-initiated studies are invaluable, especially in fields that are not particularly of interest for the pharmaceutical industry because they are either less profitable or concern special patient groups such as pregnant women. However, designing, conducting, and completing an investigator-i...

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Bibliographic Details
Published in:Thrombosis research 2020-06, Vol.190, p.39-44
Main Authors: Hamulyák, Eva N., de Jong, Paulien G., Scheres, Luuk J.J., Ewington, Lauren J., Middeldorp, Saskia, Quenby, Siobhan, Goddijn, Mariëtte
Format: Article
Language:English
Subjects:
Anticoagulants
Clinical trial
Design
Investigator initiated
Miscarriage
Thrombophilia
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Summary:Investigator-initiated studies are invaluable, especially in fields that are not particularly of interest for the pharmaceutical industry because they are either less profitable or concern special patient groups such as pregnant women. However, designing, conducting, and completing an investigator-initiated randomised controlled trial is challenging. Patients and physicians' preferences, ethics requirements, (international) legislation and funding are all areas where such challenges are encountered. The Anticoagulants for LIving FEtuses (ALIFE)2 study (NTR3361) is an example of an investigator initiated international multicenter trial that progresses slowly, at least initially, as many challenges had to be overcome. Here, we discuss the challenges we faced during the course of the ALIFE2 study up till now and we explain how some of these challenges can be tackled or even avoided. •Investigator-initiated studies are invaluable•The ALIFE2 study is an international multicenter randomized controlled trial in women with inherited thrombophilia and recurrent miscarriage•ALIFE2 is exemplary of the many challenges in designing, conducting and completing an investigator-initiated clinical trial and how these can be tackled
ISSN:0049-3848
1879-2472
DOI:10.1016/j.thromres.2020.03.015