Clinical Trials are research studies in which people (who volunteer) help doctors find ways to improve health and cancer care. Each study is dedicated to answering scientific questions and finding better ways to prevent, screen for, diagnose or treat cancer.
Today, clinical trials are conducted in most hospitals and cancer treatment centers across the U.S. To ensure the reliability of the data and the safety of all participating patients, all clinical trials researchers conduct studies under the strict guidelines of the U.S. Food and Drug Administration (FDA).
All of the advances in the control and prevention of cancer start with clinical trials. Without trials, progress would be slow to non-existent.
Should you participate in a clinical trial?
For you, your loved ones, and healthcare team to make the best decision, keep these points in mind:
- Clinical trials are open to people who meet specific requirements; every person is not eligible for each clinical trial. Eligibility to participate in a trial is determined by the sponsoring entity, and has to be approved by the FDA or NCI as well as Institutional Review Boards.
- Clinical trial participants can be among the first to receive new treatments before they are placed on the market. Remember though, these treatments are under investigation and may have potential side effects. It is your right to withdraw from a clinical trial at any time.
Questions to ask:
- What is the purpose of the study?
- Who is conducting the trial?
- Am I eligible to participate?
- What type of treatments or tests will I have to take?
- Does the treatment have side effects?
- How long will the study last?
- Why do the researchers think the treatment being tested may be effective?
- Has the treatment been tested before?
- What are the benefits and risks of participation?
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
There are risks to clinical trials:
- There may be unpleasant, serious, or even life-threatening side effects to experimental treatment. However all adverse events have to be reported and are immediately broadcast to all the investigators.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to study site, more treatments, hospital stays or complex dosage requirements.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
What are the different types of clinical trials?
- Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals or lifestyle changes.
- Diagnostic trials are conducted to find better test or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care Trials) explore ways to improve comfort and quality of life for individuals with a chronic illness.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
- In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the experimental drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- In Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits and optimal use.
Clinical trial information: Where do I begin?
Cancer Trials Support Unit
Coalition of National Cancer Cooperative Groups
Clinical trial web sites: