Therapeutic trials
Therapeutic trials are a specialised form of clinical study aimed at investigating the effectiveness and safety of new treatments. These studies are an essential part of the medical research process and help to develop new therapies and improve existing treatment approaches.
In therapy studies, a new treatment method, such as a drug (pharmaceutical), medical device or form of therapy, is tested on a group of patients. The objective is to find out whether the new treatment is more effective or safer than previous standard therapies. These studies are strictly regulated and are conducted in several phases to ensure the safety of the participants.
A central aspect of therapy studies is randomisation (random distribution). Participants are randomly assigned to a treatment group or a control group. The control group receives either the previous standard treatment or a placebo. This random allocation ensures that the groups are comparable and that the results are not influenced by other factors. Another important component is blinding. In blinded trials, the participants do not know whether they are receiving the new treatment or a placebo. In double-blind studies, the treating physicians are also not informed about the group allocation. This prevents expectations or prejudices from influencing the results.
Therapy studies can also include observational studies in which a standard treatment is used to observe how a new form of treatment works.
Therapy studies are subject to strict ethical and scientific standards. Before such a study is conducted, it must be authorised by an ethics committee. This committee checks whether the study is ethically justifiable and whether the participants are well informed and give their voluntary consent.
The results of therapy studies are crucial for the authorisation of new drugs, medical devices and therapies. They provide the scientific evidence that a new treatment is effective and safe before it is introduced into medical practice. Therapy studies therefore make a significant contribution to improving healthcare.
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