Why the study?
Designing and conducting investigator-initiated randomized controlled trials in special populations, such as pregnant women, presents numerous practical, ethical, legislative, and funding challenges.
Highlights the challenges and strategies for conducting investigator-initiated international multicenter trials, using the ALIFE2 study as a model.
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Guides planning of future investigator-initiated trials; extends ALIFE2 strategies to international multicenter cardiovascular research.
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.
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Jong et al. (2020) studied this question.
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