Within the framework of a clinical study, physicians research new therapies or methods to treat or diagnose diseases, together with their patients. This can be a new X-ray assessment or a new drug treatment. ‘Clinical’ study doesn’t mean that the study will be conducted at a clinic, but rather that the study will be carried out on humans. In contrast, before a clinical study begins, there are preclinical studies, where a drug will be evaluated in a laboratory and on animal test subjects. Only if a drug has been successful in the preclinical trials, so neither poisoning nor posing a threat to carcinogenic or damaging hereditary material , will the drug be administrated to humans. Here healthy volunteers receive the new drug within high safety measurements to show the dissemination, the time of excretion and the tolerance (phase Ia). Only if the drug has been evaluated successfully on volunteers within a phase Ia study, will further studies (phase Ib, II, III, IV) be conducted.

KliFOs is running solely phase Ib, II, III and IV studies, where the safety and tolerance have already been evaluated on humans.

Phase II: Typically, about 100 to 500 patients from various clinics and research centers participate from Germany, Europe or other countries. The patients receive either the new drug or an equivalent. The focus of a phase II study is the efficacy, tolerance, and the evaluation of the optimal dose.

Phase III (after successful phase II): Typically, about thousands of patients from various clinics and research centers participate from Germany, Europe or other countries. The patients receive the new drug or an equivalent. The focus of a phase III study is the efficacy, tolerance, and the interactions with other medications.

Assessment through the regulatory authorities: After successful completion of all the study phases above, experts from the regulatory authorities analyze all the study data. If the agencies agree, the new drug can be prescribed by a physician.

Phase IV: Already approved drugs are still under investigation. Research focuses on an optimal combination of different drugs, or the efficacy of the drug with various accompanying diseases.