Background: The German healthcare system is unique because of its different Social Security Codes (SSC), rooting back to the late 1890s. While inpatient treatment may represent one of the most advanced across all high-income countries (according to World Bank definitions), Germany still lacks integrated care. This hampers clinical research because patients cannot be followed-up after discharge from the hospital. Currently the only exemptions are occupational injuries (covered by federal SSC VII), allowing for life-long follow-up by both hospitals and private practices, and easy transfer of patient data across different care providers.
Objectives: The objective of this study was to identify deficits within the current research framework across the 9 hospitals of the German Statutory Accident Insurance, and to define basic resources needed at institutions to conduct clinical research according to international standards (i.e. ICH-GCP).
Methods: Using focus-group sessions and interviews, we developed a 30-item questionnaire to be answered by different stakeholders of the abovementioned hospitals. By pilot testing at a single centre, we redefined both the wording of individual questions as well as answering options. We mainly aimed at a qualitative assessment of data. Statistical analyses included description of baseline profiles (using means, medians, or percentages, as appropriate), and suitable measures of distribution.
Results: Preliminary data suggest a dominance of basic over clinical research across the 9 institutions investigated. We identified parallel and abundant laboratory projects which need to be both scrutinised and harmonised in the near future to avoid wasting resources. On the other hand, there is a strong demand for clinical research support (i.e. by statistical consulting, professional research associates and study nurses).
Conclusions: Even in a high-income and welfare setting, resources for clinical research are limited, and current spending does not meet current needs. Future funding must comprise complex interventions and care bundles in prevention and rehabilitation rather than individual interventions.