Risks & Benefits

There are advantages of participating a clinical trial. However, it is important to understand that some risks are involved in clinical research. Most clinical studies pose risks of minor discomfort that last for a short time. Some volunteer subjects may experience complications that require medical attention.

The specific risks associated with a clinical trial are described in detail in the consent document that participants are asked to sign before taking part in the research. Also, the primary risks of participating in a study are explained by a member of the research team. This individual will also provide an opportunity to answer questions about the study.

A medical ethics committee oversees each clinical trial to make sure all participants are treated appropriately. Also, if a participant is dissatisfied at any time during the conduct of a clinical trial, he or she is free to leave the study.

Potential Questions to ask a Research Team when Considering Participation in a Clinical Trial
  • What is this study trying to determine?
  • What treatment or test will I have, and will I receive the test or lab results?
  • What are the chances that I will get the experimental treatment or placebo?
  • What are the possible risks, side effects, and benefits of the study treatment?
  • How long will the clinical trial last?
  • Where will the study take place, and will transportation to the study site be provided if needed, such as a rideshare service?
  • Can I do any part of the trial with my regular doctor? Is there a clinical trial closer to where I live?
  • How will the study impact my everyday life?
  • How will my privacy be protected?
  • How will my health be protected during the study?
  • What happens if my health problems get worse during the study?
  • Can I take my regular medications during the trial?
  • Who will administer my care while I am in the study? Will I be able to see my own doctor?
  • Does participation in the study cost anything? If so, how will I be reimbursed for expenses such as travel, parking, or lodging?
  • Will my insurance pay for costs not covered by the research trial, or will I need to pay out of pocket? Am I still eligible to participate if I do not have insurance?
  • Will you follow up on my health after the end of the study?
  • Will I learn the results of the study?
Important Benefits in Participating in a Clinical Trial to Consider
  • Access to promising new treatments often not available outside the setting of a clinical trial
  • Close monitoring, advice, care, and support by a research team of doctors and other healthcare professionals who understand your disease or condition
  • The opportunity to be the first to benefit from a new medication or method under study
  • The chance to play a more active role in your own healthcare and gain a greater understanding of your disease
  • The opportunity to help society by contributing to medical research. You may not benefit directly from participating in a clinical trial. However, your participation helps others and makes you a partner in scientific discovery.

Right to Try Act

The Right to Try Act, signed into law in 2018, gives patients diagnosed with life-threatening diseases or conditions access to certain unapproved treatments.

Pharmaceutical companies may sometimes grant permission for an investigational drug or biologic to be given to a patient as an eligible investigational drug as part of the Right to Try Act.

To qualify, patients must have tried all approved treatment options. Also, they must be unable to participate in a clinical trial involving the eligible investigational drug.

If you are interested in Right to Try, you should first discuss this option with your physician or disease specialist. He or she can determine whether a drug or biological product meets the criteria for use under the Right to Try Act.

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