Clinical Trials: Frequently Asked Questions
Research studies conducted with patients are called clinical research studies or clinical trials. The purpose of these studies is to answer specific questions and find new and more effective ways to treat cancer patients. Most of the standard treatments used today were tested and shown to be effective through clinical research studies. There are many personal and medical reasons why a patient may choose to take part in a research study. Participation in clinical trials is always voluntary, and you may leave a study at any time.
Here are a few of the most frequently asked questions about clinical trials:
How do clinical trials work? Research studies are carefully planned. The physicians and advanced practice providers, nurses and other caregivers are chosen because they have a strong commitment to finding better treatment for cancer. They care about your comfort, health and your well-being. Highly personalized attention is given to you during treatment as you follow the research plan. Your physician can remove you from the study if it is no longer best for you. Physicians who conduct the research are monitored to ensure they follow the highest possible standards of care.
Are the trials regulated?
Yes. All clinical trials at Emory are federally regulated and approved by the Emory University Institutional Review Board (IRB). The purpose of the IRB is to protect the patient. The IRB is made up of scientists, doctors, clergy and members of the local community. The IRB reviews all studies to ensure that they are well designed with safeguards and that the risks are reasonable in relation to the potential benefits.
What do the different phases of clinical trials mean?
Phase I clinical trials do not look for medical benefits. Phase I clinical trials test a brand new drug, device or procedure. These trials determine how well humans handle the new drug or procedure and how safe it is. Phase I trials often are conducted to see which dose, or how much of a drug, works best.
Phase II clinical trials test the drug to see if it works against a specific disease (for example, a particular type of cancer). In these research studies, the researcher records the medical benefits discovered.
Phase III clinical trials compare the new drug or procedure to accepted treatments to determine which works best.
What does a "randomized" trial mean?
If you enroll in a Phase III trial, half the participants will receive the accepted standard treatment, and the other half will get the new treatment. Selection of who will receive which treatment is done in a random manner, usually by a computer. Sometimes your provider does not know which therapy a participant receives. Only when the study is complete, will you find out which medicine you received and how it performed in comparison to the other.
How do I find out about clinical trials at Winship?
Your doctor or research nurse will tell you about the treatments being studied at Winship and Emory. If you are determined to be an appropriate candidate, you will be given an "Informed Consent Form" that will discuss the purpose, risks and potential benefits of participating in the study. It is important for you to ask your doctor or research nurse to explain any part of the study that you do not understand before you sign the consent. If you choose to participate in a clinical trial, you will be followed closely by a team of caregivers during the course of treatment, as well as long term. Data collected will be recovered, reviewed, analyzed and shared with other research teams around the world. However, all data is kept strictly confidential and no information that identifies you is distributed or published.
Will my insurance cover a clinical trial?
Some insurers will cover your participation in a clinical trial and some will not. Our financial counselors will help you review your insurance policy to find out about coverage. If you are not covered, we can investigate alternatives to help pay for the clinical trial. Another helpful resource is the National Cancer Institute's guide, "Clinical Trials and Insurance Coverage - A Resource Guide."