Abstract
The safety, tolerability, pharmacokinetics and efficacy of most drugs used in pediatrics have not been studied in different age groups and are administered “off-label use”. Clinical pediatric drug trials require specific and stringent compliance with laws, regulations, guidelines, and patient/parent/public involvement, which in turn increases resource use and makes support useful from a medical, qualitative, economic, and system perspective. We examined the strengths, weaknesses, opportunities and threats of implementing a Research Department for the Support of Pediatric Studies (RDPS) in Vienna. We used the SWOT (“strengths”, “weaknesses”, “opportunities”, and “threats”) analysis to collect comprehensive data and facts on the internal strengths, weaknesses (company analysis), and external opportunities and threats (environmental analysis). The company analysis revealed a productivity gain, due to a highly specialized team and standardized processes. The environmental analysis outlined a considerable 360-degree potential for a qualitative and quantitative medical- and social-scientific expansion of the service portfolio. The establishment of a RDPS leads to the centralization of pediatric studies by bundling tasks and concentration of specialist knowledge, which enables the exploitation of synergies, the standardization of processes, the promotion of professionalism, flexibility, innovations and the reduction of inefficiencies in the form of duplication of tasks. RDPS offers tailored advice and support for different types of pediatric studies.
Highlights
The demands on healthcare facilities and their decision-makers are continuously increasing.Decision-makers of all medical disciplines have to make and constantly adapt medical and economic decisions in order to achieve or maintain optimal performance in a dynamically changing environment.Clinical research is an important pillar of evidence-based medicine, which combines individual clinical expertise with the best available external clinical evidence from systematic research to support medical decisions
With the increasing number of studies at the Department of Pediatrics and Adolescent Medicine (UKKJ) at the Medical University in Vienna in recent years, the demand for support has increased; not least, because the workload to conduct pediatric clinical trials is very high due to the very strict national and international legal and regulatory requirements. In view of these challenges and the expected increase in pediatric studies, we investigated the role of a Research Department for the Support of Pediatric Studies (RDPS) at the UKKJ of the Medical University of Vienna in improving the efficiency and the effectiveness of pediatric research
The implementation of a RDPS at the UKKJ in Vienna is is discussed against the background of the expected increase in pediatric studies, the expected discussed against the background of the expected increase in pediatric studies, the expected increase increase in ethical and legal norms, and the challenges in funding
Summary
The demands on healthcare facilities and their decision-makers are continuously increasing.Decision-makers of all medical disciplines have to make and constantly adapt medical and economic decisions in order to achieve or maintain optimal performance in a dynamically changing environment.Clinical research is an important pillar of evidence-based medicine, which combines individual clinical expertise with the best available external clinical evidence from systematic research to support medical decisions. The demands on healthcare facilities and their decision-makers are continuously increasing. Decision-makers of all medical disciplines have to make and constantly adapt medical and economic decisions in order to achieve or maintain optimal performance in a dynamically changing environment. Clinical research is an important pillar of evidence-based medicine, which combines individual clinical expertise with the best available external clinical evidence from systematic research to support medical decisions. The individual clinical expertise encompasses the competence of the clinician, while the external clinical evidence processes clinically relevant and patient-centered research results [1]. Clinical research plays an important role with regard to the request for standardized clinical decision-making. Researchers already have pointed out avoidable weaknesses in clinical research in general [2]
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