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What are the risks of joining a clinical trial?

Joining a clinical trial is associated with some risks, since all the effects of a new medication may not be known yet. New treatments can have side effects, which can make people feel unwell. It’s very important that clinical trial participants tell the doctors if they start to feel unwell. Also, clinical trial participants must have regular check-ups throughout the trial, which can take up a lot of time.

There are some potential risks associated with clinical trials. The treatment may have side effects or produce adverse reactions. You may be assigned to the group receiving the standard of care, or you may receive the experimental treatment but not derive any benefit. In some cases, you may have some added inconveniences, such as frequent trips to the study site, hospital stays or difficult or uncomfortable procedures, depending on how the trial is designed. Participation in clinical trials isn't always free, so be sure to find out whether your health insurance will cover related costs.

Bottom line: Be sure to learn all you can and weigh your options before enrolling in a clinical trial.

There are risks involved with the treatment of any life-threatening illness, including treatment offered through clinical trials. Some of the risks include:

  • There may be difficult side effects from medications or treatments.
  • The treatment may not be effective.
  • The clinical trial may require extra time for trips to the study site, treatments, hospital stays or complex dosage requirements.

However, through the process of "informed consent," your medical team will make sure you understand all the potential risks and benefits of the clinical trial.

There are generally known and unknown risks associated with clinical trials, such as:

  • There may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.
  • The treatment may not be effective for the participant.
  • The protocol may require more of the participant's time and attention than a standard treatment. (Participants may need to visit the study site on a regular basis, be subjected to additional tests, get more treatments than are normally necessary, stay in the hospital and/or follow complex dosage requirements).

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.