Risks of participating in a clinical trial

Participant safety is a top priority, which imposes requirements to obtain numerous approvals and clearances before the first participant is enrolled in a study. Regulators are tasked with balancing whether the potential benefits of participating in a study outweigh the risks.

Prior to the commencement of any clinical trial, the trial protocol, as well as many other documents used in the trial, must be positively approved by the regulator, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. In addition, the Bioethics Committee is the body that gives its opinion on ethical aspects of conducting clinical trials. Only after obtaining all required approvals and permits, the sponsor together with the research team may start the clinical trial.

The greatest risk arising from participation in clinical trials is the lack of sufficient information on the safety of the investigational drug. As a result, events or adverse reactions unforeseen from previous studies may occur. In addition, there is a chance that planned procedures in the study may prove harmful to the participant, such as a biopsy. However, in most studies, additional (optional) consent is required for potentially harmful procedures that do not affect further participation in the study. The study doctor is required to inform the subject of both the potential benefits and risks of participating in the study before signing informed consent.

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