Implementing a Clinical Research Department to Support Pediatric Studies
A SWOT Analysis
Bibliographic Data
| ID | 15512862 |
|---|---|
| Authors | Alexandra Thajer (0000-0002-1051-1141, Medical University of Vienna), Margit Sommersguter-Reichmann (0000-0002-0501-8416, University of Graz, corresponding author), Henriette Löffler‐Stastka (0000-0001-8785-0435, Medical University of Vienna) |
| Year | 2020 |
| Volume | 17 |
| Issue | 17 |
| Pages | 6211-6211 |
| Publication date | 2020-08-27 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | International Journal of Environmental Research and Public Health (JOURNAL) |
| Journal identifiers | ISSN: 1661-7827 • E-ISSN: 1660-4601 |
| Publisher | Multidisciplinary Digital Publishing Institute (PUBLISHER • CH) |
| DOI | 10.3390/ijerph17176211 |
| PMID | 32867050 |
| OpenAlex | W3080412147 |
| Language | EN |
| References cited | 23 |
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
Business · Flexibility (engineering · Management · Portfolio · Process management · Strengths and weaknesses · SWOT Analysis · Childhood Cancer Survivors' Quality of Life · Ethics and Legal Issues in Pediatric Healthcare · Medicine · Pharmaceutical studies and practices · Psychology · Marketing
| Highly cited | No |
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