Building a competitive infrastructure to support clinical research in healthcare institution

Abstract

Background: Clinical research is becoming increasingly popular in Europe at a growth rate much higher than expected, especially in Benelux. Although traditionally thought to be the purview of academic health centres, clinical research to evaluate new drugs, devices and medical practices is being done more and more in healthcare organizations with little or no academic affiliation.

Methods: By managing a new infrastructure and centralizing resources and demands, clinical research unit (CRU) has become an effective mechanism for hospital research. The 'infrastructure' or CRU refers to the necessary resources and how the CRU is organized and communicates operationally to conduct clinical research within the institution. The creation of a new CRU within the Robert Schuman Hospital in Luxembourg is described in this article.

Results: This article discusses the concrete steps and basic elements such as patient-centric and hospital approaches needed to create and structure a CRU to provide academic or industry-sponsored research support in clinical research.

Conclusions: Some infrastructure challenges (insufficient engagement, regulatory and administrative barriers) and possible courses of action (standardized procedures, training and centralization) will be discussed.

Keywords: clinical infrastructure; clinical management; clinical research; clinical trials.