Clinical trials in immunotherapy

Prior to approval, new drugs being tested for safety and effectiveness are called “investigational” or “experimental” medications. Clinical trials are the controlled studies of these investigational drugs. The main goal of clinical trials is to validate a drug’s safety and effectiveness, but they also help determine a variety of other factors, including the drug’s associated side effects and recommended dosages. The results of clinical trials help the Food and Drug Administration (FDA) decide whether to approve the drugs and release them for public use.

In some cases, patients may want to participate in a clinical trial to gain access to certain medications before they’re officially approved by the FDA. Patients who participate in clinical trials are offered a number of benefits, including early access to potentially revolutionary new medications, playing an important role in advancing medical research, and receiving the very best standard of care with close monitoring by experts in the field.

Cancer immunotherapy clinical trials study ways to treat cancer through immunotherapy. There are currently hundreds of clinical trials in various stages studying innovative immunotherapy drugs as new treatments, in combination with other treatments or as new uses for already approved treatments. Without patient participation in clinical trials, the immunotherapy treatments that exist today wouldn’t be available.

To qualify for a clinical trial, each patient must meet certain eligibility criteria. Cancer type, overall health and treatment history may be considerations depending on the type or phase of the trial. Because cancer immunotherapy is dependent on immune system function, a properly functioning immune system is often a qualifying factor for immunotherapy clinical trials. The clinical trial staff will be able to determine whether you are eligible to participate in a specific trial.

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