Cancer Clinical Research Trials

What are clinical trials?

Clinical Trials are research studies that involve people who are willing to test new ways to prevent, treat, or diagnose disease, such as cancer. They answer important scientific questions that we hope will improve the care and treatment of patients today and in the future. All of the successful treatments we have today, are based on the test results of previous clinical trials. A clinical trial may be a treatment option for your disease.

How are clinical trials conducted?

The doctors who conduct clinical trials follow carefully written “protocols”, which are like a recipe to follow the treatment plan. The protocol clearly states who is able to join the study and what will be done during the study. Some trials test one new treatment in all patients in the study. Other trials may test a new treatment and compare it to the current standard (most accepted) treatment. If you do not receive the “new” treatment, you will receive the standard treatment.

Before you join a clinical trial, the doctor and research nurse will explain the study, why it is being done, what to expect during the study, and what the benefits and risks may be. They will determine if you are eligible to enroll in the trial. You will be given a consent form to read and sign. Joining a study is completely voluntary.

Why would I be interested in a clinical trial?


Patients volunteer for trials for many reasons. Trials may offer a new drug, in addition to standard treatment, that is currently not available except in the clinical trial. The new treatment may show promise in treating a disease. They may hope for a cure, a longer time to live, or a way to feel better. Many patients want to help in the research effort to improve treatments.

How are patients protected in a clinical trial?


Patient safety is extremely important and you will first receive medical tests, as part of the screening process, to be sure it is safe for you to join the study. If you are enrolled in a trial, you will be watched closely and data collected throughout the clinical trial. If the treatment in a trial is not helping you, the investigator may decide to stop the study. You can decide to leave a study for any reason, at any time. If you decide to leave a study, other treatment options will be discussed with you.

Are there benefits to a clinical trial?


Being on a clinical trial may offer cutting edge therapy not available outside of a clinical trial. The new treatment may be as good as or better than the standard treatment. If a new treatment is proven to be better, you will be among the first to receive it. You also have the chance to help patients in the future if the trial proves to be better. You will receive care from a special research team.

Are there risks to a clinical trial?


Sometimes the new treatment is not better or even as good, as the standard treatment. There may be unexpected side effects that are worse than treatment with the standard regimen. Side effects can vary from patient to patient and can be temporary or permanent. The disease itself can cause symptoms, not related to the treatment. Weighing the potential risks against the benefits can help to make a decision.

Questions to ask:

• What is the purpose of the study?
• What kinds of tests and treatments will be done?
• Are there other treatment options?
• What are the possible short and long term effects expected from this treatment?
• How long will the study last?
• Will I have to be in the hospital or is it given as an outpatient?
• Are there any added costs not covered by insurance?
• Is anything paid for by the study?
• How long to I have to decide before joining the trial?


How do I find a clinical trial?

Many oncologists offer clinical trials.  Ask your oncologist if you are eligible to participate. 

Martin Memorial offers a number of clinical trials for patient participation to test new treatments compared to standard regimens. Clinical trials are available through membership with the Southwest Oncology Group (SWOG), Moffit Cancer Center and pharmaceutical companies.
Learn more about clinical trials at Martin Memorial >>

Further information and resources

ClinicalTrials.gov - http://clinicaltrials.gov/
National Cancer Institute - www.cancer.gov/CLINICALTRIALS
Medline Plus - www.nlm.nih.gov/medlineplus/clinicaltrials.html