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To Trial or Not to Trial: That Is the Question

By Hilary Wright

(Page 1 of 4)

In order to clarify any confusion, clinical trials are often referred to in a number of other terms by the members of the medical-scientific community, such as clinical study, research protocol, or medical research, all meaning the same thing ... clinical trial. The National Cancer Institute (NCI) defines a cancer clinical trial as "an organized study conducted in people with cancer to answer specific questions about a new treatment or a new way of using an old treatment." The process of finding out about an appropriate clinical trial for a loved one usually begins by discussing the possibility with their oncologist (cancer specialist). Once you and your loved one have decided upon a particular clinical trial, and feel it could prove beneficial, a few more factors must be considered which may still affect whether your loved one will want to participate or not.

Every clinical trial has its own guidelines for who is eligible to be a part of the study. Generally, participants are alike in several ways, either having in common the same type and stage of cancer, age, gender, or previous treatments. Eligibility criteria are generally included in the study plan, and you can find out if your loved one is eligible for a particular study by talking to their doctor or to the doctor or nurse in charge of enrolling patients in the study. Cancer clinical trials may consist of a little bit of everything, and can be found to exist in different formats, like:

  • Treatment trials: where new treatments for cancers are tested, including new drugs, new approaches in surgery or radiation therapy, or a new combination of treatments or methods, such as gene therapy or immune therapy.

  • Prevention trials: tests new medicines, vitamins, minerals, or other supplements which may lower the risk of certain types of cancer. These trials look for ways to either prevent cancer in people who have never had it, to prevent cancer from coming back, or prevent a new form of cancer from occurring in people who already have cancer.

  • Screening trials: this tests for the best ways to find cancer, especially in its’ earliest stages.
  • Quality of Life trials: also called Supportive Care trials, ways are explored to improve comfort and quality of life for cancer patients.
    It must be understood that if your loved one is found to be eligible for a clinical trial that is for a new cancer drug, the clinical research will involve a series of steps referred to as “phases” in order to test the new drug. These phases allow researchers to ask and answer questions that will result in reliable information about the drug, as well as protection for your loved from any possible problems. Clinical trials are usually classified into one of three phases:Phase I trials: These are the first studies in which people are evaluated on how a new drug should best be administered (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is considered to be safe. Usually only a small number of patients are enrolled in this phase, sometimes as few as a dozen.
  • Phase II trials: A phase II trial continues to test the safety of a drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

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