Abstract

Abstract Clinical research is a pivotal element for the Emilia-Romagna (Italy) healthcare system. Since 2009, several regional legislative acts established that clinical research was one of healthcare workers’ institutional activity as well as healthcare assistance and recommended each public Hospitals and Local Health Trusts (LHTs) to set up a research infrastructure (RI) to support clinical researchers. The goal of this intervention was both to assess the regional RI organization and to design a policy fostering the development of a RIs’ regional network. Our work, that took place in one year, consists of three-steps conducting: (I) a survey on all 15 RIs to assess their organizational model; (II) an interview to the key informants of each RIs to assess their strengths and weaknesses; (III) a three-round Delphi survey to evaluate the stratification of the activities in terms of complexity. The survey showed a high level of heterogeneity among RIs in terms of organizational structure, activities, human and instrumental resources and strengths and weaknesses. For example technological, economic, and human resources were considered opportunities, although difficulty at hiring data managers emerged as a potential threat. The Delphi panel assigned 3 levels of complexity (low, medium, high) to each activity carried out by RIs: 14 (47%) were considered low (mandatory for all RIs); 11 (37%) were considered medium (needed in RIs with medium volume/complexity of research activities) and, lastly, only 1 (3%) was considered high (needed in RIs with high complexity of research activities); for 4 (13%) activities no consensus was reached. The survey showed high level of heterogeneity and fragmentation among regional RIs in terms of organization, activities, resources and support offered to researchers. It also identified which level of complexity each RI should have and proposed possible solutions fostering a regional network of RIs to improve research activities in our Region. Key messages • Research is a key element of any innovative healthcare system. Public research needs a strong coordination. • This work enabled policymakers to draft a policy based on evidence coming from stakeholders.

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