Possible benefits and risks of participation
Participating in a clinical trial offers subjects an opportunity to actively participate in their own healthcare.
Subjects may have direct benefits from having access to the treatment which would otherwise be unavailable to them (e.g. state-of-the-art cancer medication or medicines not covered by health insurance). Contribution to medical research is also important because it may provide benefits to other patients and generations to come. Previous generation subjects, who participated in clinical trials of medicinal products used today, helped to investigate medicines without which modern medicine would be unimaginable.
Subjects who participate in clinical trials are also provided with enhanced monitoring of their medical condition, and with the level of care that is sometimes unattainable in ordinary practice.
Although there is no guarantee of successful treatment within a clinical trial, those who conduct a clinical trial believe the new medicinal product will be better and more successful than the current standard treatment.
If no direct benefit to a subject is expected from participation in a clinical trial because it involves, testing of biochemical parameters, of mechanism of action, subjects should be informed of this in advance in order to make their decision on whether to participate or not.
Risks of participating in a clinical trial include lack of efficacy or potential adverse effects or side effects of an investigational medicinal product as well as risks associated with trial procedures. These risks also include the possibility of receiving a placebo. In clinical trials which are using a placebo, special patient monitoring procedures ensure that patients whose conditions due to receiving a placebo do not have an expected effect of treatment can start receiving the active medicinal product, or are excluded from the trial before any detriment to their health can occur. In treatment of severe diseases, only trials where patients receive supporting standard treatment in addition to a placebo are accepted.
The trial doctor (investigator) is required to make the subjects aware of all known risks before the trial begins. Before a trial is approved, competent authorities assess the risks to subjects and approve trials only where such risks are justified and acceptable in relation to the benefits. Most risks are known before a trial begins, but if new risks are discovered in the course of a trial, subjects must be informed of that fact in order to choose whether they want to continue to participate or not.
Each clinical trial is covered by an insurance policy and patients are entitled to compensation if they sustain an injury as a result of participating in a trial.