 |
 |
  |
|
|
|
 |
|
|
|
| |
Creativity, competence and professionalism for success
Clinical trials play an essential role in the R&D activities of the pharmaceutical industry.
The results of these studies generally form the basis for decisions regarding marketing
authorization of the products. On the other hand studies are time-consuming and require
considerable financial resources - and this with an outcome which is difficult to predict.
Experience has shown that "run-of-the-mill" solutions may not be appropriate in all cases - even
in simple bioavailability studies. Those who go into phase-I clinical studies with the intention
of only meeting the regulatory criteria, may fail to obtain additional information which could
be important for the planning of successive clinical trials or for later use in therapeutic
practice. Thus, in order not to miss these chances, we devote to every project - whether complex
absorption site studies or simple bioavailability investigations - our full competence, creativity
and professionalism in designing and conducting the trial.
A thorough scientific evaluation of the findings is particularly important when predefined goals
of a study can not be attained. What are the possible grounds and what steps should be taken?
Should a reformulation be recommended prior to repeating the study? These are questions where
practical solutions have to be addressed and then verified clinically. Scientific evaluation in
this field is very familiar to us since we are frequently asked for advice in regard to questions
such as these.
Phase-II/III clinical trials: advantages of monocentre studies
In certain cases a monocentre approach in clinical studies has advantages also in later phases
of clinical drug development. Our experience in such projects has demonstrated that statistically
unequivocal results can be attained even when small numbers of patients are enrolled in a study.
This is because a reduced variability in the efficacy endpoints is often only achievable in a
monocentric setting. We would be pleased to share with you our experience in designing and
organizing such projects.
|
|
|
|