Summary
Background: The data protection requirements matured in parallel to new clinical tests generating
more personal data since the 1960s. About ten years ago it was recognized that a generic
data protection scheme for medical research networks is required, which reinforces
patient rights but also allows economically feasible medical research compared to
“hand-carved” individual solutions.
Objectives: To give recommendations for more efficient IT infrastructures for medical research
networks in compliance with data protection requirements.
Methods: The IT infrastructures of three medical research networks were reviewed with respect
to the relevant data management modules. Recommendations are derived to increase cost
efficiency in research networks assessing the consequences of a service provider approach
without lowering the data protection level.
Results: The existing data protection schemes are very complex. Smaller research networks
cannot afford the implementation of such schemes. Larger networks struggle to keep
them sustainable. Due to a modular redesign in the medical research network community,
a new approach offers opportunities for an efficient sustainable IT infrastructure
involving a service provider concept. For standard components 70–80% of the costs
could be cut down, for open source components about 37% over a three-year period.
Conclusions: Future research networks should switch to a service-oriented approach to achieve
a sustainable, cost-efficient IT infrastructure.
Keywords
Clinical trials - biomedical research - computer security - databases - pseudonyms