What is a Clinical Trial?

What is a Clinical Trial?

A Clinical Trial is the final testing grounds that researchers use to get a drug or procedure approved by the FDA. The first round of tests happens in the lab, then on animals. Then after a long and arduous process when the drug or procedure has been deemed safe enough, the testing phase moves into the clinical trial phase where it’s tested on humans.

You might be wondering if clinical trials are safe and a good fit for you. Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed.

Researchers have used clinical trials for years to develop and launch new treatment protocols. This type of research has also given us a more effective way to diagnose and prevent cancer and helped in minimizing and managing side-effects.

Benefits of a Clinical Trial

  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • You may be able to get information about support groups and resources.

Risks of a Clinical Trial

  • The new treatment may cause serious side effects.
  • The new treatment may not work or it may not be better than the standard treatment.
  • You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
  • The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.

Criteria to Join a Clinical Trial
Each trial has a different set of criteria that a patient has to meet to be accepted. This helps to ensure the safety of each patient and that no one is put at risk. By meeting the certain criteria, the group selected is as similar as possible making the medical test results more accurate.

The most common criteria that a patient has to meet are:
Fall into a certain age group
Diagnosed with a particular type of cancer the clinical trial is targeting
Received or not received certain treatments in the past

When either you or someone you love is diagnosed with cancer, knowing all the options available to treat the cancer is important when it comes to making the best decision about treatment. This could include the use of clinical trials at University Cancer Centers. Contact a University Cancer Centers facility near you to inquire about upcoming clinical trials in your area.

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