Potential Risks and Inconveniences
Although new medicines are extensively tested in the laboratory and in animal studies, new side effects may be detected when the medicine is given to human participants for the first time.
While new medicines are generally expected to work as well or better than existing therapy, this may not turn out to be the case in an individual participant.
Clinical trials often require participants to visit the hospital repeatedly, undertake additional tests, and follow certain other instructions which may be inconvenient for some participants.
At the beginning of the trial each participant is informed of the risks and benefits of participation that are specific for that trial. Participants are included in a trial only after obtaining a signature on an information document and consent form from each participant.
Participation in clinical trials is entirely voluntary. Even after opting to participate in a trial, patients are permitted to change their mind and refuse to continue participation whenever they want, without having to give any reason.
Each trial plan and the information to be provided to participants is reviewed by a committee of independent experts before the trial starts. These experts may ask for changes to the study plan in order to safeguard the rights, benefits and safety of participants.
Trials for new medicines are started only after approval from the government.
Serious events during a trial are relatively rare, but when they happen, all costs of treatment are borne by the sponsor unless independent experts come to the conclusion that the event was not related to the trial.
Irreversible side effects are extremely rare, but when they occur, participants receive compensation based on norms set by the government.
