Patients / Volunteers / Donors in Clinical Research
Clinical studies are accomplished in particular for new pharmaceuticals or medical devices, sometimes also for homoeopathics, cosmetics or food. Before pharmaceuticals or medical devices become certified for the market, it must be proven that they are effective and that their application benefits outweigh their risks. This has to be demonstrated in clinical studies.
- In phase I the product is used for the first time on humans. Usually, for the investigation of drug effects healthy voluntary persons are enlisted. For the risks, which they take, they are paid and insured.
( Aix Scientifics® rarely accomplishes phase I studies with pharmaceuticals. Please refrain from applying without request. )
- Phase II studies are usually quite small. In this phase detailed questions are answered.
- In phase III it must be proven that the product is both, effective and safe (relatively). Participants of such studies are patients suffering of exactly the disease(s), for which product certification is aimed for.
The physician asks the patient whether s/he agrees to participate in the study. In addition, the patients must be informed verbally and in writing about both, the product and the study. The patient avowed its agreement in writing.
A patient is insured against damages caused by the product under investigation. ( Almost all studies, which Aix Scientifics® accompanies, belong to this or the next category. ) The physician is instructed how the product is to be used and which data has to be collected.
- Pharmaceuticals and medical devices, which pose a threat for healthy persons (e.g. chemotherapeutic agents or implants), are investigated from the beginning on, in patients suffering from the respective disease(s).
- Phase IV studies and post-marketing surveillances are performed after certification of a pharmaceutical 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 receives few, and/or no instructions, how the patient is to be treated, but instructions, which set of data has to be collected. The patients are insured in the context of the normal product liability. As far as no violation of patients' rights takes place, the patient does not need to be asked for participation. ( Aix Scientifics® accompanies also phase IV studies. )
In clinical studies accomplished by Aix Scientifics® only the physician and its staff have direct contact to the patients. Only s/he informs potential patients asking them whether they are willing to participate in the study. Only s/he collects study data and forwards these 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.