Clinical studies are controlled systematic evaluations in humans to gain new knowledge about diagnostics and therapy of diseases.Before a new drug can be launched, proof of efficacy and safety of the drugs is required by law. This proof is done by clinical studies. The clinical studies are categorized into phases I-IV.
Phase I Testing is done in healthy volunteers
Number of volunteers: ~ 20-80
Duration: some hours to some days
Goals: Pharmacokinetik, Drug safety, Pharmacodynamik.
Phase II Testing patients with symptoms or diseases for which the test substance was designed
Number of volunteers: 100 - 300
Duration: app. 4-12 weeks
Goals: Efficacy, Safety of the substance, Dose finding.
Phase IIIa before application of approval is submitted afterwards Phase IIIb
Number of patients: 1000 - 3000
Duration: few months up to some years
Goals: Effectiveness, Safety qualitatively and quantitatively, confirmation of clinicallly relevant drug interactions under testing conditions, Information for the Product-Information.
Phase IV after approval and launch of a drug
Duration: unlimited
Goals: Assessment of the therapeutic value of the drug, Recording of adverse drug effects or long term evaluation.
What about my security?
Before a patient participates in a clinical trial the patient will be fully informed about nature, duration, and scope of the clinical study by a physican. The patient will be informed which evaluations he has to undergo during the study. By signing the consent form, the patient documents that he is sufficiently informed and that he wishes to participate in the study. The consent may be withdrawn at any time without causing any disadvantages for the patient. For each clinical study a patient insurance is required by law. It covers risks, such as injuries during the participation in a clinical study.
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