Clinical trials are essential for improving prevention, diagnosis and treatment of diseases. Such trials are subject to many national and international guidelines and they follow ethical principles.
In clinical trials potentially new treatment options or pharmaceuticals which have shown to be potentially effective against diseases are applied to patients
The main objective of clinical trials is to prove the efficacy and harmlessness of a new treatment option or a new pharmaceutical. The efficacy of a new form of treatment must never be at the expense of patients’ safety. Therefore, the benefit of a therapy must always outweigh the possible risk. This is of crucial importance for conducting clinical trials.
In clinical trials comparable patients (with the same disease) for example are treated with different therapy concepts, in order to determine whether a new therapy concept is more efficient than the conventional treatment. Once the efficacy of the new treatment form has been verified, it may become a standard therapy for a certain disease.
Any clinical trial on humans must be based on strict scientific and ethical principles as well as on legal regulations. An ethics committee reviews all clinical research projects and gives its opinion on ethical questions. In order to ensure the safety of trial participants, it is usually mandatory that the trial is reviewed and approved by national and local authorities. However, there may be regional (country-specific) differences in the legal regulations.
Conducting a trial
For each trial, a so-called trial protocol is made up. It specifies in great detail what is to be examined and how to conduct the trial. Furthermore, the background of the clinical trial is explained and it justifies the necessity of conducting this trial. If multiple centres (sites) participate in this trial (multicentre trial), each centre (trial site) works according to the same protocol.
Trial participants must be made aware of the scope and consequences of the participation beforehand. For this purpose, eligible patients are first informed about all important aspects of the trial, before they voluntarily sign an informed consent form. During the conversation, possible trial participants are informed on the purpose of the trial, the examinations and evaluations that will be done, the conduct of the trial, and possible risks and expected benefits.
After closure of a clinical trial, the compiled results are thoroughly analysed by the investigators and other scientific staff. This is to ensure that the results have a high significance and that on their basis profound decisions can be made for future procedure. Once the safety, harmlessness and efficacy of the new pharmaceutical have been validated in the clinical trial, the pharmaceutical can become standard therapy after its approval. This means that this kind of treatment is then generally accepted and ready to be applied.
The results of clinical trials are often published in medical journals. Before publication, however, all articles are thoroughly checked by other experts to ensure that the analyses and conclusions are reasonable and substantial. In case of very important trial results that are of general interest, it is possible that these results are presented and discussed in the media, at scientific congresses or within patient organisations before they are officially published.