Understanding & Participating in Clinical Trials
About Clinical Trials
Every therapy, drug or approach that is in place today to treat cancer had its start in a clinical trial. Florida Cancer Specialists comes together with Sarah Cannon Research Institute, the research arm of HCA’s global cancer institute and one of the world's leading clinical research organizations, to bring innovative treatment options to patients throughout Florida. By partnering with Sarah Cannon, FCS is part of a network that reaches more clinical trial patients than any single cancer center.
With a shared focus on clinical excellence and cutting-edge research, Sarah Cannon and FCS are not only personalizing treatment but also transforming the standard of care by advancing today’s clinical trials into tomorrow’s treatments.
Together, they have enrolled more than 6,000 patients on innovative studies to find more effective treatments for many types of cancer.
Through the launch of the Sarah Cannon Research Institute Phase I Drug Development Unit (DDU) at FCS, patients in Florida have convenient access to latest therapies with the comfort of friends and families nearby.
Clinical trials are studies that evaluate the effectiveness of drugs or treatment routines. Our goal is to give patients the opportunity to participate in approved and exploratory therapies without long-distance travel. Clinical trials are not available for every condition. Talk to your doctor to discuss your options, or call (239)274-8200 and ask to speak to member of our research team.
What Are Clinical Trials?
Clinical trials are designed to assess the safety and effectiveness of new cancer drugs, changes in dose and modification of dosage regimens for existing drugs. Clinical trials play an important role in improving cancer treatments and are necessary for new, improved treatments to be approved and made available to all patients.
How Are Clinical Trials Conducted?
Clinical trials are intended to test treatments under very specific guidelines. Protocols are written in advance which define the purpose, design and conduct of a clinical trial. All research centers which participate are required to follow the same research protocol. The protocol is written by the sponsor of the study and outlines how the study will be conducted and who may participate. The protocol defines when the participants will be assessed and in order to ensure patient rights and safety, the protocol is also reviewed by an Institutional Review Board (IRB).
Clinical Trials Safeguards
Side effects and benefits for any cancer treatment vary depending on the individual patient. There are guidelines in place to protect the research participants. The research team conducting the study will explain any known or anticipated risks ahead of time. Participants are provided written information about the safeguards during the informed consent process, prior to starting any clinical trial therapy.
What is involved?
You will meet the study coordinator and the physician who will be tracking your progress during the study. The research study will be explained to you in detail including the potential risks and benefits, alternatives to participation, length of the study, number of required study visits, all required study procedures, exams, and tests.
You will be given the Informed Consent Form explaining the study in detail. If you volunteer to participate in the research study, you will sign the Informed Consent Form. Your consent to participate is strictly voluntary and you have the right to withdraw your consent at any time.
The screening process
You will be interviewed regarding your medical history and all current medications.
Screening exams, tests, procedures, physical exams will be done according to the requirements of each particular study. These procedures were discussed in the initial interview and on the Informed Consent form.
After all of the screening tests and procedures results are complete and you are eligible to continue according to the study guidelines, you will then start the study procedures. Some patients may not qualify for the study. Those individuals will stop all procedures when deemed ineligible.
After completing the screening process, you will be assigned the study medication. Each study will have its own individual schedule, which was discussed at the initial interview and on the Informed Consent form.
Your compliance with taking the study medication will be assessed throughout the study. You will be required to return all study medication containers at each study visit. Depending on the study, you may be required to keep a daily diary between visits, and there may be additional testing and procedures required throughout the study.
After the study
At the end of the study, the study coordinator and the physician will do a final assessment, including a physical exam they will collect all remaining study supplies. They will also make follow-up recommendations, if appropriate. You may be contacted in the future for any new studies in which you may be interested.
Why Participate in Clinical Trials?
Clinical trials are designed to evaluate the effectiveness of new treatment interventions. The objective of these clinical trials is to test new therapies in patients who have cancer. Patients participate in clinical trials for several reasons, including:
- The potential to benefit from a new drug or treatment procedure
- Improved management of symptoms resulting from treatment from treatment or cancer
- The opportunity to directly contribute to improving the understanding of how to treat a cancer and ultimately, benefit other patients
Patients who participate in clinical trials receive either a promising new treatment or the best available conventional treatment. If a new treatment option is proven to work, patients who are participating in the clinical trial will be among the first to benefit. While there is no guarantee that any treatment will be successful, clinical trials have been proven to offer some of the most effective cancer treatments currently available today.
What are the Costs of Participating in Clinical Trials?
There are two types of costs associated with a trial:
Patient care costs; and
Patient care costs
These are costs associated with providing medical goods and services to any patient with a given diagnosis and prescribed therapy. Usual care costs include doctor visits, hospital stays, clinical laboratory tests, x-rays, and any other medical costs that occur regardless of whether a patient is participating in a clinical trial or receiving standard treatment.
These costs are usually covered by a third-party health plan, such as Medicare or private insurance.
Research costs are costs that are associated with clinical trial participation, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes.
These costs are usually covered by the sponsoring organization, such as a pharmaceutical company.
Be sure to consult with your physician and research coordinator about the financial aspects of any trial you are evaluating.
Medicare Coverage of Clinical Trials
For up-to-date information about Medicare coverage of clinical trials, visit the Web site http://www.cms.hhs.gov/ClinicalTrialPolicies to view the Medicare Clinical Trials Quick Reference Guide. As of January 2001, the following information was accurate:
Medicare Approved Clinical Trials
In general, cancer treatment and diagnosis trials are covered if:
The trial is funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other Federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients' costs. Patients should ask their doctor about this before beginning a clinical trial.
The purpose or subject of the trial is within a Medicare benefit category. For example, clinical trials focused on the diagnosis and treatment of cancer are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.
Medicare patients who wish to participate in a clinical trial that is not described above, or patients who are unsure whether their trial meets all of the requirements should discuss these concerns with their doctor or visit http://www.hcfa.gov/medlearn/refctmed.htm for the Medicare Clinical Trials Quick Reference Guide. Often, there are other available trials that might be covered, so it is important that patients consult with their physician to evaluate their options before beginning a clinical trial that is not covered.
Medicare Covered Costs
Any medical service normally covered by Medicare (usual care costs) is still covered when it is provided as part of a clinical trial, including tests, procedures, and doctor visits.
Usual care costs, even if it is a service or item used in the experimental treatment, are covered. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug. Also, a test or hospitalization that Medicare would ordinarily cover for a cancer patient would still be covered, even though the services required resulted from a side effect from the experimental drug or treatment.
Medicare Non-Covered Costs
Investigational items or services being tested in a trial (research costs) are typically not covered. Sponsors of clinical trials often provide the new drug free, but patients should be sure to determine whether this is the case before beginning a trial.
Items or services used solely for the data collection needs of the trial (research costs) are typically not covered. For example, lab tests, x-rays or CT scans that are required more frequently than usual for the purpose of research are not covered.
Items provided free by the sponsor of the trial, such as drugs or specialized procedures are typically not covered.
Phases of Clinical Trials
Development of new anticancer agents and treatment strategies occurs in four phases. Each phase is designed to determine specific information about the potential new treatment such as its risks, safety and effectiveness compared to standard therapy. The hope is that the new therapy will be an improvement over the previous standard therapy.
Phase I Trials
Phase I trials usually involve a small number of patients and the primary goals of this phase are to determine the activity in humans, the maximum tolerated dose, how the drug works in the body, the side effects and duration of side effects. Upon completion of phase I trials, the information that has been gathered is used to begin phase II trials.
Phase II Trials
Once the information is analyzed from phase I trials, phase II trials are designed to assess the effectiveness of the treatment in a specific patient population. These trials usually include larger numbers of patients than phase I trials. Drugs or therapies that proved to shove activity in phase II trials may be approved for standard treatment or require additional evaluation in phase III trials.
Phase III Trials
Phase III trials typically compare a new drug or therapy with a standard therapy in a randomized manner. This allows a direct comparison to determine effectiveness. Phase III trials require a large number of patients to measure the statistical strength of the results.
Phase IV Trials
Once the drug or treatment becomes part of standard therapy, the manufacturer of the drug may elect to initiate phase IV trials. This phase includes continued evaluation of the treatment effectiveness and monitoring of side effects as well as implementing studies to evaluate usefulness in different types of cancers.