What are clinical trials?
Clinical trials are research studies designed to test new treatments in people with cancer.

Why are Clinical trials important?
Clinical trials are important for a number of reasons:

• Clinical trials contribute to knowledge and progress in the fight against cancer;
• Clinical trials help develop new, effective treatment against cancer;
• Knowledge gained through clinical trials helps everyone affected by cancer;
• Patients who take part in clinical trials may benefit from the treatments they receive.

Patient participation in clinical trials is one of the most important keys to finding a cure for cancer.

What are the phases of Clinical trials?
Clinical Trials are conducted in four phases:

• Phase I clinical trials test a new treatment for safety, side-effects, and the doses tolerated by people.

• Phase II clinical trials evaluate whether or not the new treatment works on the cancer.

• Phase III clinical trials compare the new treatment with the existing standard treatment to determine if it is as good as or better than the standard.

• Phase IV clinical trials continue to evaluate the long-term safety and benefits of therapies that have been approved by the FDA.

ClinWorks specializes in early-phase clinical trials. Early-phase clinical trials are considered Phase I and II clinical trials.

Why are early-phase clinical trials important?
Data from early-phase clinical trials are important to develop new treatments for cancer. Clincal trials help:

• Establish safety
• Identify promising drugs that merit further development for cancer treatment
• Get the drug through the approval process and out to the patients who need them (with positive results)
• Scientists recognize and fix problems early on, resulting in the development of better treatments for cancer (with negative results)

What are the benefits and risks of participating in early-phase clinical trial?
Benefits associated with early-phase clinical trials:

• Clinical trial participants have early access to new treatment before it becomes available to the general public.
• Patients who participate in clinical trials receive a high level of care from cancer experts who monitor their disease closely.
• Patients in clinical trials may be helped by the new treatment they receive.
• Patients contribute valuable information that may help the future of cancer care for other cancer patients.

Risks associated with early-phase clinical trials:

• There may be unknown side-effects (including possibly death) that were not predicted since the treatment is new and under study.
• There is no guarantee that patients will be helped by the new treatment and could possibly be harmed.

How do I know if participating in an early-phase clinical trials is right for me?
Talk with your doctor and your loved ones concerning your treatment decisions and desire to participate in a clinical trial. ClinWorks Cancer Research Center personnel are available to answer your questions regarding clinical trials and to help you through that difficult decision process. Ultimately, only you can decide whether taking part in an early-phase clinical trials is right for you.

More information regarding clinical trials can be found on the American Cancer Society’s website: www.cancer.org and the National Cancer Institute’ web site: www.cancer.gov.