Clinical Trials

What Are Clinical Trials?

Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer.  The goal of this research is to find better ways to treat cancer and help cancer patients. 

Why Are Clinical Trials Important?

Clinical trials are important in two ways:

  1. Clinical trials contribute to knowledge and progress against cancer.  If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients.
  2. Patients who take part may be helped personally by the treatment(s) they receive.

Cancer Clinical Trials Include Research at Three Different Phases

Each phase answers different questions about the new treatment.

Phase 1 trials are the first step in testing a new treatment in humans.  In these studies, researchers look for the best way to give a new treatment (e.g., by mouth, IV drip, or injection? How many times a day?).  They also try to find out if and how the treatment can be given safely (e.g., best dose?); and they watch for any harmful side effects.

Phase 2 trials focus on learning whether the new treatment has an anticancer effect (e.g., does it shrink a tumor? Improve blood test results?).

Phase 3 trials compare the results of people taking the new treatment with results of people taking standard treatment (e.g., which group has better survival

rates? fewer side effects?). In phase 3 trials, patients are assigned at random to receive either the new treatment or standard treatment.

Should You Take Part in a Clinical Trial?

This is a question only you, those close to you, and your physician(s) can answer together.

Weighing the Pros and Cons

Possible Benefits

  • Clinical trials offer high-quality cancer care.
  • If a new treatment approach is proven to work and you are taking it, you may be among the first to benefit.
  • By considering the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
  • Health insurance and managed care providers do not always cover all patient care costs in a study.  To find out in advance what costs are likely to be paid in your case, talk to a doctor from the study.

Your Rights, Your Protections

Before and during a cancer treatment study, you have a number of rights.  Knowing these can help protect you from harm.

  • Taking part in a treatment study is up to you.  It may be only one of your treatment choices.  Talk with your doctor.
  • If you do enter a study, doctors and nurses will follow your response to treatment carefully throughout the research.
  • If researchers learn that a treatment harms you, you will be taken off the study right away.  You may then receive other treatment from your doctor.
  • You have the right to leave a study at any time.

For more information go to the National Cancer Institute’s (NCI) web site http://cancertrials.nci.nih.gov   This site is the NCI’s comprehensive clinical trials information center for patients, health professionals, and the public.