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Table 3 Description of the steps in therapeutic innovations with examples.

From: Qualitative assessment of innovations in healthcare provision

Step

Therapeutic innovation

Example

I

Preliminary data confirm optimized application of a therapeutic procedure. Only data on effect and safety from clinical studies are available.

Improved tolerance, lower cost, or easier application of therapeutic procedures.

II

Therapeutic benefit can be expected under everyday conditions due to a weak correlation of surrogate parametersa with desired endpoints.

Reduction of tumor size after chemotherapy with unknown influence on quality of life or survival.

III

Therapeutic benefit is confirmed under everyday conditions by surrogate parameters which correlate highly with the desired endpoint(s) or achievement of endpoints.

Improvement in a defined area of quality of life or survival is confirmed.

  1. aIf surrogate parameters correlate only weakly, there is only a weak correlation between the confirmation of those surrogate parameters and the actually desired endpoint(s).
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BMC Health Services Research

ISSN: 1472-6963

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