Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

1Department of Anesthesiology, Critical Care, Emergency Medicine, Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium

2Department of Pneumology, Ziekenhuis Oost-Limburg, Genk, Belgium

3RapidMiner, Shanghai, China

4Faculty of Organizational Sciences, University of Belgrade, Belgrade, Serbia

*all authors contributed equally

Corresponding Author:

Sven Van Poucke, MD

Department of Anesthesiology, Critical Care, Emergency Medicine, Pain Therapy

Ziekenhuis Oost-Limburg

Schiepse Bos 6

Genk, 3600


Phone: 32 +32475269857

Fax:32 89327905

Email: svanpoucke [at]


Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

J Med Internet Res 2016;18(7):e185

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