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From the hypothesis to a proof of concept
The optimization of well established drug products, that have already been successfully used in
therapeutic practise, is generally recognised as a promising development strategy along with
innovative drug research. The potential for such improvement in efficacy and safety may only
become obvious after several years of therapeutic use.
Proof-of-concept studies - preferably in a phase-I setting
In order to confirm an optimization of a product, it is necessary to verify improved therapeutic
efficacy in clinical trials. This process usually begins with poof-of-concept studies carried out
under strictly controlled conditions.
Experience has shown that the variability of clinical endpoints in such trials can often be reduced
significantly by performing the project in a phase-I setting rather than using a multicentre approach.
For SocraTec R&D, it is therefore a matter of principle that we carry out proof-of-concept studies -
whenever possible - in our Clinical Pharmacology Unit in Erfurt.
However, we are also experienced in performing multicentre studies using our regional network of
specialized physicians and hospitals. Such an approach may be advantageous when investigating the
efficacy of medicinal products for new indications or examining the relationship between dose and
effect (dose-finding studies).
Dr. Frank Donath, principal investigator and director of our Clinical Pharmacology Unit, has many
years of experience in research and development in the pharmaceutical industry and this is a valuable
asset in scientific consultations and in putting together the concept and design for a project.
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