If you are considering whether to participate in a clinical trial or not, one of the most salient issues that might be troubling you is why you should partake in something researchers are unsure will work. You may also be wondering if there are underlying risks behind the project you intend to participate in.
We understand your reservations and have taken steps to allay your fears through this article.
Are There Any Risks In Clinical Trials?
Just like any medical treatment, test, or procedure, clinical trials have risks. However, measures have been put in place to reduce the occurrence of these risks.
Some of these risks which may or may not occur are:
- The new treatment may have certain side effects or cause you to become uncomfortable.
- The effectiveness of the new treatment may not be better than existing treatments.
- Your schedule may be affected by the trial. For instance, you may be required to travel or stay in the hospital for a while, which may not be convenient for you.
- You may not be part of the experimental group that gets the new treatment or drug. Instead, you might be placed in the control group, which means you get the standard treatment.
How Are Clinical Trial Participants Protected?
Clinical investigators are mandated to follow stringent rules enforced by the government to ensure that the safety of participants is prioritized. Every clinical trial follows a detailed study protocol that stipulates what the researchers will do.
The head researcher or principal investigator closely monitors the study process to ensure that the protocol is followed and that every participant is safe. An independent body known as the Institutional Review Board, which consists of qualified medical professionals, scientists, and ordinary citizens just like you, also regularly evaluates the study to ensure that risks to participants – if any – are mitigated to the lowest levels.
Also, clinical trials are closely monitored by a Data, and Safety Monitoring Committee made up of medical experts. They periodically look at the study results as it progresses. If they realize the experimental treatment isn’t working as expected or has too many risks, they will stop the trial immediately.
Before joining a clinical trial, you would have to undergo a process known as the informed consent process. Here, you will be told what to expect during the clinical research as a participant. In addition, you will be informed of possible side effects of the treatment and other associated risks.
During this process, you will have the opportunity to ask any question about the trial that you deem relevant. All this information will help you decide whether to go ahead with your participation by signing the informed consent form.
Researchers are also mandated to keep your personal information private, including your medical records. Finally, if you decide to leave at any stage during the trial, your wish would be granted and confidentiality maintained.
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