Understanding Cancer Clinical Trials

Cancer clinical trials are research studies designed to help improve how we test for, treat and manage cancer and its symptoms. They help answer questions, including whether a new treatment works, is safe, and is more effective than current treatments.

After years of research and testing in the lab, clinical trials take place and are implemented quite far along in the research process. All cancer treatments must go through clinical trials before being FDA approved. Contrary to popular belief, clinical trials are not only for late-stage or terminal cancer cases. There are trials available for many types of cancer at all stages.

There are several different phases to clinical trials:

• Phase 0 – whether a potential new drug works. Clinical trials at this phase tend to involve very low doses of a drug in very small samples of people. The goal is to determine a treatment’s potential and whether to proceed with further studies. Participation in Phase 0 clinical studies typically does not benefit current patients – but can benefit future cancer patients.
• Phase I – whether a drug is safe. Trials at this phase explore what dose of a new drug can be given to people without causing significant side effects. As there is some risk to the participants, they tend to use small sample sizes. Because of these phases’ risk to benefit ratio, participants usually consider Phase I trials when other options have been exhausted.
• Phase II – whether a treatment works. If a treatment passes Phase I, it will proceed into Phase II, which explores how well a treatment works on certain types of cancer. “Success” in these trials depends on the goal of the study. It may be to shrink or eradicate a tumor, prevent a cancer from growing, prevent cancer from returning, or improve quality of life. Phase II trials are usually performed at major cancer centers or sometimes community hospitals.
• Phase III – whether a treatment is more effective than current treatments. Phase III trials compare the new treatment against existing standard treatments. Participants are usually randomly assigned either the new treatment or the current one to see how the two compare. Phase III trials take longer than Phase I and II studies and are more widely available.
• Phase IV – gathering additional data on an approved treatment. Phase IV trials occur after a drug has been FDA approved and are used to answer questions regarding the treatment’s long-term effects or efficacy. Trials at this stage are the safest as they use FDA-approved treatments. Although you can receive these drugs as part of a normal course of treatment, participation in a Phase IV trial helps researchers learn more about relatively new drugs and their long-term effects.

What to consider before participating in a clinical trial

Different types and phases of clinical trials come with different risk and benefit profiles. Before joining a trial, make sure you understand what participation means to you and your course of treatment. Ask questions about exactly what the trial involves, what phase the trial is in, what to expect, how it will affect your treatment, and whether your insurance will cover it.

Weighing the risks and benefits of participation in a clinical trial is vital, so be sure to understand them before deciding.

Clinical trial benefits include:

• Helping to advance cancer research
• Access to a new treatment that may work better than current treatments
• Increased treatment options
• More frequent access to your care team
• Having some or all of your care covered by the study sponsor

Clinical trial risks include:

• Unknown side effects or risks
• Unknown efficacy of the treatment
• More time spent at the doctor or hospital
• Not having a choice in what treatment you receive or not knowing what treatment you are receiving
• Receiving care that your insurer might not cover

When deciding whether to participate in a clinical trial, gather as much information as possible and carefully weigh the pros and cons. You can also speak to your healthcare team about any questions you might have. You are not obligated to participate in a clinical trial – whether you decide to or not is entirely up to you.

At Southwest Women’s Health and Oncology, our patients have access to a number of clinical trials at various phases. We are proud to offer patients access to cutting-edge technologies and treatments. Working in partnership with Optimum Clinical Research Group and Optimum Human, we enjoy an exceptional reputation in the local community and are highly regarded by academic research centers and the pharmaceutical industry. We are always happy to discuss the pros and cons of participation with our patients to make an informed decision that’s right for them. For more information about clinical trial participation or book an appointment with our oncology team, contact us.