Through clinical trials at Winship, our researchers and clinicians are able to develop new treatment options which provide you with access to cutting-edge care that is often not available elsewhere. In fact, 75 percent of new cancer treatments approved by the Food and Drug Administration since 2007 have come through clinical trials at Winship, many initiated by Winship teams.
As a patient, a cancer clinical trial is an important option for you to consider when deciding your course of action.
Types of Clinical Trials
Clinical trials occur in three phases necessary for FDA approval of a new treatment option:
Phase I Clinical Trial:
Phase I trials study whether a new treatment is safe to use over a range of doses. Sometimes a drug is being used for the first time in humans. The treatment may be given to people with different types of cancers. A Phase I trial is mainly a drug safety study and tends to be small, enrolling around 20 patients.
Learn about Winship's Phase I Clinical Trials Unit.
Phase II Clinical Trial:
Phase II trials study how well a treatment works for a certain cancer. These trials may include between 25 and 100 people. After a drug (or procedure) is found to be effective in treating cancer in a Phase II trial, a Phase III trial will study it further.
Phase III Clinical Trial:
Phase III trials compare the new drug or procedure to accepted standard treatment to see which works the best. Phase III trials may look at different doses of the same drug, different drug combinations or different sequences of giving drugs. In these trials, people are randomized to get either the new treatment or the standard treatment. Phase III trials are large, enrolling hundreds or sometimes even thousands of participants.
While a clinical trial is a good choice for some people, clinical trials have possible benefits and drawbacks. You can always stop participating in the clinical trial at any time.
- Cancer clinical trials offer high-quality cancer care. In cancer clinical trials if you do not receive the new treatment being tested, you will receive the best standard treatment. This may be as good as, or better than, the new approach.
- If a new treatment approach is proven to work and you are taking it, you may be among the first to benefit.
- By looking at the pros and cons of cancer clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
- You may have the chance to help others and improve cancer treatment.
- New treatments in cancer clinical trials are not always better than standard care. You may have side effects that medical care providers do not expect or that are worse than those of standard treatment.
- Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.
- If you receive standard treatment instead of the new treatment being tested, it may not be as effective as the new approach.
- Health insurance and managed care providers do not always cover all patient care costs in a clinical trial. Talk to a financial counselor to find out in advance what costs are likely to be paid in your case.