•  the researcher will have to rely on biological material, i.e. on a contact to bio banks that can provide cellular material of highly specific diseases,
•  the medical technician must work hand in hand with the product manufacturer to ensure that the test can be optimally matched to the drug,
•  the family doctor will have to rely on clear information from the pharmaceutical company, e.g. how the diagnostic results should be interpreted and what the consequences are for the dosage of the drug, and
•  the pharmacist will likely face completely new, highly complex questions from the patient.

…just to mention a few examples.

Many companies publish information about their efforts to develop the appropriate diagnostic procedures along with the drug. The idea of personalized medicine also gives rise to many cooperative projects between the pharmaceutical industry and biotech companies, which is of enormous importance for the German market, where biotechnology is strongly represented.

How does this new trend affect patient recruitment?

At the PerMediCon forum in June 2013 the challenges associated with the principle of personalized medicine which pharmaceutical companies are facing were described. On the one hand, the group of patients for whom the drug may be suitable – and this isbased the principle of personalized medicine itself – will be getting smaller, because the inclusion criteria in terms of the diagnosis alone will become much more complex. On the other hand, enough patients must be included in the relevant study so that the statistics are as accurate as possible. Therefore, it is already clear that the principle of personalized medicine will be a major challenge for designing a study and for the successful, quick recruitment of patients in order to avoid driving up the ever-increasing costs of clinical trials even more.

Autor: Cécilia Mesa, 02.04.2014

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