What does it mean to be a trial subject - and what are the reasons for becoming one?
Being a trial participant means that you voluntarily take part in a health science trial. The trial is conducted because researchers believe that the new treatment might be better or at least as good as the current standard treatment. But they don't know for sure, and that's why the trial is done.
Some people want to participate in a trial in the hope of improving their condition, while others want to participate to help research and future patients. Generally speaking, as a trial subject, you will not benefit directly from participating in a research project, but you will contribute to gaining new knowledge that in the long term can, for example, prevent disease and benefit people with a particular disease.
You can either become a research subject on your own initiative or by being contacted. If you have been asked to participate - e.g. by your own doctor or the hospital - the trial may involve a new type of medicine, additional examinations or a new surgical method. If you are healthy and are considering applying yourself, possibly on the basis of an advertisement, the trial could be about body functions, lifestyle or disease prevention.
Legislation and Ethics
Legislation determines how and under what conditions a trial may be conducted. The legislation is there to safeguard the rights of the trial subject, which apply regardless of whether the participant is a patient or a healthy person. Of course, if you are a patient and decide not to participate, you can always be sure that you will still receive the best known treatment (the standard of care).
The interests of trial subjects are also looked after by the scientific ethics committees, which must always approve the trial. It is important that new, valuable knowledge is created, but in this regard, your safety and well-being are more important than scientific and societal interests. As a trial subject, you should always receive detailed information - both written and verbal - about the specific project in which you may participate.
Some trials compare the standard treatment with a new experimental treatment that researchers believe may be better. This is done by randomly dividing participants into two groups: one that receives the standard treatment and one that receives the experimental treatment. The allocation is called randomization and is done so that the two treatments can be compared as closely as possible.
Some people may feel uncomfortable with the random allocation of treatments. However, it is important to emphasize that those who receive the experimental treatment may receive a better treatment than those who receive the standard treatment. Those who receive the standard treatment, on the other hand, are guaranteed to receive a proven treatment. If, during the trial, it turns out that the investigational treatment is inferior to the standard treatment, the trial will be stopped and all subjects will then receive the standard treatment.
Some trials take several years, and when a trial is completed, researchers will review the results. They can then assess whether the trial treatment has proven to be better than the standard treatment, or they can use the new knowledge to make future treatments better.
The Ideal Trial Participant
When you choose to participate as a trial subject, it is important that you comply with the agreements and measures required by the study. For example, taking your medication at a certain time, keeping a diary or not eating certain foods. If the agreements are not followed, there is a risk that the study results will be unreliable.