Frequently Asked Questions About Cancer Clinical Trials

Sometimes the newest and most innovative approaches to cancer treatment are only available through clinical trial. 

You may consider participating in a clinical trial if:

• No current treatment exists for your type of cancer
• Standard treatment was unsuccessful
• Your cancer has returned
• You want to help advance medical science that will help cancer patients today and in the future

It takes years to develop, test and perfect a new cancer treatment. A clinical trial is the last step in studying a new treatment before it can be approved by the U.S. Food and Drug Administration (FDA). Clinical trials are conducted in phases, starting with the smallest group and then expanding to all patients.

Phases of Clinical Trial

Phase 1 (20-80 people). A phase 1 clinical trial is designed to determine a treatment’s dose and delivery method, if there are any side effects, and its effectiveness in fighting cancer.

Phase 2 (100-300 people). A phase 2 clinical trial is designed to continue gauging a treatment’s effectiveness in fighting cancer while monitoring for any side effects.

Phase 3 (1,000-3,000 people). A phase 3 clinical trial is designed to continue gauging a treatment’s effectiveness in fighting cancer while monitoring for any side effects. Data also is used to compare this new treatment with a current treatment. Following phase 3, a new treatment can apply for FDA approval.

Phase 4 (all patients). An approved treatment continues to be monitored to measure its benefits and any long-term side effects.

To scientifically assess a new treatment, clinical trials may be designed as:

Randomized: Patients are randomly assigned to a study group. This way researchers can measure how well a new treatment works compared to a current treatment. 

Blind: If a clinical trial is blind, patients do not know which treatment they receive. This keeps patients from unknowingly influencing the results. 

Double-blind: If it is double-blind, neither the researchers nor the patients know who receives which treatment. This prevents patients and researchers from unknowingly influencing the results. 

Including a placebo group: Rare in cancer clinical trials, a placebo is designed to look like the treatment but has no effect. It may be used when a new treatment is added to a current treatment to keep the study blinded.

You will be screened for the clinical trial’s enrollment criteria, which may include: 

• type and stage of cancer
• age range 
• medical history
• overall health status

Your participation in a clinical trial is completely voluntary and you can withdraw at any time.

Each clinical trial has a protocol that outlines every detail of the study. The protocol is approved and monitored by our cancer center’s Institutional Review Board (IRB) to protect your safety and your rights. A protocol includes: 

• Goal of the clinical trial 
• Data the clinical trial will collect 
• Patient enrollment criteria
• Length of time, including enrollment period, treatment and follow-up 
• How the treatment will be delivered, the dose and how often 
• Required tests
• Principal investigator (usually a doctor or Ph.D. researcher) responsible for the clinical trial

Participating in a clinical trial can have its risks and benefits. It’s important to weigh those when deciding whether to enroll. 

Risks

• You are not guaranteed any benefit compared to standard treatment
• You may experience unforeseen side effects
• Clinical trial treatment can require more time and testing than standard treatment

Benefits

• You have access to an innovative cancer treatment that is not available to all patients
• Provides hope when other treatments have failed
• Being in a clinical trial can be rewarding, knowing you are helping advance our understanding of cancer and its treatments for today and the future

John Theurer Cancer Center conducts more clinical trials than any other cancer center in New Jersey, andenrolls more than 1,500 patients each year. 

No one is better equipped to provide you with the most innovative approaches to treating cancer. Ask your doctor if you may qualify for a clinical trial at John Theurer Cancer Center for your type of cancer, or contact our cancer clinical trials office at 551-996-1777.

Learn more about Clinical Trials at John Theurer Cancer Center.