Pre-Clinical and Clinical R&D

Clinical Trials


Like any new medicine, Octapharma’s biopharmaceuticals are developed through a series of prospective clinical trials, which assess their safety and efficacy by applying high scientific standards.

 

The first step is pre-clinical toxicology and pharmacology analyses, where an experimental human protein product is tested in laboratory and animal studies.

 

After pre-clinical testing, the medicine can advance to clinical testing in people. Together with experts in the corresponding therapeutic areas, Octapharma's Clinical R&D teams design and execute highly regulated clinical trials that can take several years to complete.

Corporate clinical studies in different countries are managed by clinical research departments located in Austria and Switzerland, with support from US staff in case of Investigational New Drug (IND) studies.

Octapharma-sponsored clinical trials are registered in the US National Institute of Health Registry.

Clinical Development Phases

Phase I

A new drug is administered, for the first time, to humans with the aim to evaluate how the drug should be given, how often, and what dosage is safe. Usually only a small number of patients or healthy volunteers are enrolled into phase I trials.

Phase II

The safety of the drug continues to be tested, and evaluations begin on how well the new drug works in treating an illness or medical condition and what dose is appropriate. Information about the drug's safety, side effects, and potential risks is also collected.

Phase III

The new drug is tested in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random. Phase III trials often enrol large numbers of people. Additional information about the effectiveness and safety of the new drug is gathered and provides the primary basis for the risk-benefit assessment and much of the core information that will be described in the labelling of the medicine.

Non-Interventional Studies

Non-interventional studies are conducted after the regulatory approval of a medicine. Through such trials, researchers collect additional information about long-term risks, benefits, and optimal use during routine clinical treatment. These trials often involve hundreds of subjects and may continue for many years.