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Clinical Trials

Testing drugs to determine their efficacy and safety are basic requirements for the therapeutic application of drugs on humans and animals. While in the past the requirements profile for human pharmaceuticals was clearly more stringent than for animal pharmaceuticals, the last decades have seen an increase in required drug testing for animal pharmaceuticals; meanwhile the standards for both types of pharmaceuticals are practically the same.

Basically, a distinction must be made between preclinical and clinical studies. In the preclinical stage, animal experiments and, increasingly, test models examine issues related to the toxicology, the mechanism of action, metabolism and even dosing. The results of such preclinical studies determine whether active ingredients and treatments can be tested on humans in the subsequent trials phase.

Trials are categorized in 5 phases (0-IV), based on the specifications of the US-American Food & Drug Administration (FDA), to minimize any related risks.

In phase 0 about 10-15 patients help to answer questions related to pharmacokinetic and pharmacocynamic properties. Applied dosages are below the dosages expected for therapeutic application.

In phase I about 20-80 volunteers are tested to examine additional pharmacokinetic and pharmakodynamic parameters and also the safety or tolerability of the respective drug.

In phase II the therapeutic concept is put to test (phase 2a) and the appropriate therapeutic dosage is determined (phase 2b). These tests involve up to 200 probands and therapeutic effects should be revealed.

In phase III drug testing enters a decisive stage. Prior to the actual market authorization a larger number of patients (from some hundreds to some thousands) are tested to prove the efficacy of the drug. Tests are performed against a standard therapy or, if a new therapeutic area shall be developed, against a placebo group. If this phase renders positiv results – which automatically implies positive results for all previous tests – the market authorization procedure for this drug can be initiated.

Once the drug has been approved, additional clinical trials are performed with a large collective of patients (in the million range) in phase IV; the main goal is to also detect rare and very rare side effects.

While research-conducting pharmaceutical companies often perform such clinical trials themselves, external institutes that are specialized in clinical pharmaceutical testing (so-callsed clinical or contract research organizations or CROs) are increasingly commissioned to conduct clinical trials. Advantages include the specialization and internationality of these research organizationsand also the availability of suitable probands or patients.

Clinical research associates (CRAs) are commissioned to perform the practical clinical testing; they make contact with trial sites and investigators, prepare trial protocols together with the doctors in charge and forward the trial protocols for evaluation. Often, these researchers are scientists (chemists, biologists), pharmacists, veterinarians, medical doctors and nurses or specialized pharmaceutical consultants and pharamceutical representatives.