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Clinical trials are essential to find better ways to prevent, diagnose or treat a disease. 

Trials are funded or sponsored by a range of sources:

  • federal agencies such as National Cancer Institute
  • pharmaceutical companies
  • hospitals
  • physicians
  • foundations
  • advocacy groups

Clinical trials are part of a long, careful process, and are governed by a rigorous review and oversight process designed to protect the rights and safety of patients who participate. 

There are several different types of clinical trials:

  • treatment
  • screening
  • diagnostic
  • prevention
  • supportive care trials

The most well -known type of clinical trial is a treatment trial, where a new drug, new combination of drugs, or new surgical or radiation therapy approach is tested for safety and effectiveness in a controlled setting. Clinical trials are conducted in a progression of steps called phases.

Phases of a clinical trial:

  1. Phase I trials are the first step in testing a new therapy in humans. The investigational therapy is tested in a very small group of patients to find the safest dose of a new drug that can be used without causing harmful side effects. If the treatment successfully passes through a Phase I trial, it moves forward to be studied in a Phase II trial.
  2. Phase II trials test how well the new therapy works in a certain type of cancer, while carefully monitoring side effects. Fewer than 100 patients may be included in a Phase II trial, and if the treatment is effective in enough patients, it may be moved to a Phase III trial.
  3. Phase III trials compare the new therapy to currently approved standard treatment in a large number of patients–sometimes several thousand patients across the country, or even around the world. Phase III trials are randomized, meaning patients will be randomly assigned to a new therapy being studied, or to a currently approved standard treatment.
  4. Phase IV trials find more information about a treatment that is already approved for use in patients.

Why are clinical trials randomized?

Randomization is a proven process of assigning study patients to a treatment group in order to avoid bias. Bias occurs when people’s opinions or other factors not related to the treatment being studied influence the study, thereby changing the study results.

Neither the doctor nor patients choose which group they will be assigned when randomization is used. If the new therapy is found to be effective and meets safety requirements, an application will be submitted for FDA approval. If approved, this new treatment becomes another standard available for patients in the future.

Many patients mistakenly believe that by taking part in a study, they may be given a placebo or no treatment at all for their cancer. This is not the case. A placebo is only used when no standard treatment exists.

For example, a Phase III clinical trial may randomize patients after completion of standard care, to receive either placebo or a new drug. This type of study is testing whether the new drug, given in combination with standard treatment, may enhance benefit.

Clinical Trial Patient Protection

Washington Cancer Institute protects patients who choose to enroll in clinical trials by a careful informed consent process. During this process, the patient learns many details about the study, so he or she can make a decision about participating. Participating in a study is completely voluntary-there is no pressure to join the study, and the doctor will care for the patient without prejudice should the patient choose not to join.

Before a study can be offered to a patient, it must undergo a careful review process by scientific review and ethics review committees. These local committees are responsible to ensure the study meets appropriate scientific principles, while protecting the research patient and following all federal and local laws. This review and approval process takes place before a study can begin, and while the study is being conducted. Patients will be informed of any important new information that is learned throughout the conduct of the study.

Clinical Trial Awareness

Although there are about 5,000 cancer trials taking place on an ongoing basis, research has consistently shown that only a small percentage of newly diagnosed patients are aware of the possibility of participating in a clinical trial for the treatment of their cancer. According to a recent study conducted by the Coalition of Cooperative Cancer Groups and Northwestern University, only three percent of adult cancer patients participate in clinical trials. Of those who participated in a cancer clinical trial, the majority reported having a positive experience. Very few reported feeling like a “guinea pig.” More than 90 percent reported they had been fully informed of the trial’s risks and benefits, were treated with dignity and respect, and would recommend participating in a clinical trial to others with cancer.