Patients / Volunteers / Donors in Clinical Research

Clinical studies are accomplished in particular for new medicaments or medical devices, sometimes also for homoeopathics, cosmetics or food. Before medicaments or medical devices become certified for the market, they must be proven to be effective and that with their application the benefits outweighs the risks. In order to be able to meet these statements surely, usually clinical studies must be performed.

• In the phase I the product is used for the first time at humans. For medicaments voluntary healthy persons are enlisted. For the risk, which they are received, they are paid and insured. ( Aix Scientifics^® rarely accomplishes phase I studies with medicament. Please you refrain to apply without being asked. )
  
• Phase II studies are usually quite small. Here aimed detail questions are answered.
  
• In the phase III it must be proven that the product is effective and safe (relatively). The participants of such studies are patients with exactly the diseases, for which the product is to become certified.
  The physician asks the patient whether he agrees to participate in the study. In addition it must clear the patients up verbally and in writing over the product and the study. The patient avowed its agreement in writing.
  A patient is insured against damages arising by the new product. ( Nearly all studies, which Aix Scientifics^® cares for, fall in these or the next category. ) One prescribes for the physician, how the product is to be used and which data has to be collected.
  
• Regarding medicaments and medical devices, which are too dangerous for healthy ones, e.g. chemotherapeutic agents or implants, for the first contact patients with the appropriate diseases are already asked to participate in such a study.
  
• Phase IV studies and post-marketing surveillances are performed after certification of a medicament or a medical device for the market. It is to be examined at a large number of applications how the product is used in the market and whether thereby rare side effects are discovered. The physician gets few, and/or no regulations, how is to be treated, but some which data has to be collected. The patients are insured in the context of the normal product liability. As far as in the rights of the patient one does not intervene, the patient does not need to be asked for the participation. ( Aix Scientifics^® cares for also phase IV studies. )

In the clinical studies accomplished by Aix Scientifics^® only the doctor and his staff have direct contact to the patients. Only he informs potential patients asking them whether they are willing to participate in the study. Only he collects study data and gives them to Aix Scientifics^®. Aix Scientifics^® usually has no direct patient contact. Furthermore, we are not in the position to give any medical advice. _{Author: E.G.F.}