What are the risks of a clinical trial?
Clinical trials are a crucial part of medical research. They are indispensable in testing new drugs or treatments for various diseases and conditions. However, just like any medical treatment, there are risks involved in participating in a clinical trial, and measures are taken to ensure participants’ safety.
Every clinical trial in the US is approved by an Institutional Review Board (IRB). The IRB, also called the “Ethics Committee,” ensures that the risks to participants are as low as possible. The IRB reviews the study protocol to ensure it is safe for participants and that the potential benefits of the tested drug outweigh the risks.
Potential side effects and reactions
The risks associated with clinical trials are potential side effects and unknown reactions to the investigational drugs. The frequency of the side effects varies from very common to very rare, and their severity ranges from mild to serious when hospitalization is required. During the screening visit and before each drug dose administration, the medical team informs the subjects about the importance of reporting unusual feelings.
Adverse events are collected from the screening visit until the end of the study visits or even longer when the protocol has defined an additional follow-up period. The clinical investigators must monitor every side effect, related or not to the study drug, and report them precisely.
Risks associated with Phase 1 studies
Phase 1 trials are the first stage of testing a new drug or treatment and are conducted on healthy volunteers only. These trials use limited doses of the investigational drug but are immediately stopped if serious adverse effects are encountered. Biotrial follows strict rules to ensure participant safety, including 24/7 medical team presence during an inpatient stay or telephone support during outpatient periods.
Ongoing safety monitoring
Clinical trials require ongoing safety monitoring to detect adverse effects or reactions to the investigational treatment. Biotrial has a dedicated safety team that closely monitors each participant’s health throughout the trial. As soon as an adverse event occurs in a subject involved in a clinical trial, the Principal Investigator (medical doctor in charge of the study) or the clinical staff reviews the subject’s laboratory results and requests additional tests when necessary to ensure proper diagnosis and determine the intensity of the event.
Investigators must report promptly to the sponsor (pharmaceutical company) and the Institutional Review Board any adverse effect that may reasonably be or probably caused by the investigational drug. Any safety concerns are promptly addressed, and the trial may be modified or stopped if necessary to ensure participants’ safety.
Mitigating clinical trials risks
Biotrial adheres to the strict US FDA regulatory framework to ensure participants’ safety.
The informed consent process is an essential part of protecting participants in clinical trials. Before joining a clinical trial, participants are informed about what to expect, including the potential risks and benefits of the tested treatment. The informed consent process also allows participants to ask questions and make an informed decision about whether or not to participate. It is important to note that participation in a clinical trial is voluntary, and participants are free to withdraw at any time and without providing any reason.
Biotrial partners with Verified Clinical Trials (VCT), a global database registry designed to improve patient safety and detect protocol violations. The VCT system is imposed on Biotrial volunteers and involves a fingerprint check before the screening visits to prevent simultaneous clinical trial enrollments and duplicate subjects.