Clinical Trials

One of the biggest advantages to our practice is the opportunity to benefit from ongoing medical research. We are committed to being involved in the latest research, in order to find new and better treatments for our patients. 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 contact our clinical research team at (239) 274-9930.

What are Clinical Trials?

A clinical trial is a research study designed to evaluate potential new treatment options. These studies are the result of a long and deliberate cancer research process that often takes years. Clinical trials test the safety and effectiveness of new or modified cancer drugs, new drug doses, unique approaches to surgery or radiation therapy, and varied combinations of treatments. Clinical trials are an integral component for improving the treatment of medical conditions because they lead to higher standards of care. In the United States all new cancer treatment products must proceed through an orderly clinical trials evaluation process to ensure that they have an acceptable level of safety and demonstrate benefit to helping patients with a specific cancer before they become commercially available to other patients.

Clinical trials essentially fall into two general categories:

  1. The first general category of clinical trials are designed to evaluate new drugs, compounds, or biologic agents that have not yet been approved by the Food and Drug Administration (FDA) for administration to patients. All substances must go through several phases of clinical trials to document their safety and effectiveness before the FDA approves them for routine use to treat cancer patients. Prior to FDA approval, these substances are only available through clinical trials; however, after FDA approval, they are commercially available.
  2. Clinical trials may also evaluate drugs, compounds, or biologic agents already approved by the FDA for the treatment of one type of cancer. These substances have already been determined to be safe by the FDA and they are now being evaluated in different doses, schedules, and combinations to determine how to optimally use them for the treatment of a variety of cancers.


How Are Clinical Trials Conducted?

Clinical trials are designed to test treatments under very specific scientific and ethical guidelines. Clinical trials use written protocols to define the purpose, design and conduct of a specific clinical trial. All of the research centers participating in a particular study use the same research protocol. The protocol is written by the sponsor of the study and explains what the trial will do, how it will be conducted, where it will be conducted, who may participate and how and when the participants will be evaluated. Sponsors of clinical trials include, but are not limited to, the National Cancer Institute, groups or networks of physicians, individuals within a single cancer institution and manufacturers of biopharmaceutical products. In order to protect patients participating in clinical trials, the sponsor reviews the protocol for safety and appropriateness and then the protocol must undergo a second neutral review by an Institutional Review Board (IRB). The Institutional Review Board is responsible for overseeing any clinical trials that are performed in the specific healthcare institution where the clinical trial is offered/conducted. An Institutional Review Board includes physicians, healthcare providers and individuals not involved in healthcare, including the clergy or ordinary citizens/consumers. Institutional Review Board members do not have any personal interest in the results of the trial and, therefore, can ensure that the study is conducted fairly and safely. Committee members serving on Institutional Review Boards address the following questions in reviewing protocols:
• Does this protocol have scientific value?
• Does the protocol have scientific validity?
• Does the study have a valid scientific design and yet pose an inappropriate risk for subjects?
• Are risks to subjects minimized?
• Are the risks to subjects reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result?
• Is the selection of subjects equitable?
• Are additional safeguards in place for subjects likely to be vulnerable to coercion or undue influence?
• Will informed consent be obtained from research subjects or their legally authorized representatives?
• Is there adequate provision for monitoring the data collected to ensure the safety of subjects?
• Are there adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data?

The Institutional Review Board also reviews all informed consent documents to make sure that they provide clear and complete information for those evaluating the merits of enrolling in a specific clinical trial.

Clinical trials evaluating cancer treatments or strategies may be offered in large university hospitals, local community hospitals and/or physician practices. The location where a clinical trial is conducted depends on the specific resources required to conduct the trial, the number of patients needed for enrollment in the trial to answer the question and the individual or institution's interest in performing clinical trials in general.


Clinical Trials Safeguards

Both standard care and clinical trials have risks, side effects and benefits that vary depending on the individual. However, there are rigorous guidelines in place to protect the well being and safety of clinical trial participants. The physician and research nurse conducting the study will explain any known or anticipated risks ahead of time. Once a patient's eligibility for a specific trial is established, the research nurse will explain the informed consent process. Informed consent is one of the patient's most important rights in the research process, as it outlines the purpose of the study, the exact treatments that will be administered, all possible side effects, and the patient's right to withdraw from the study at any point. Signing the consent form acknowledges that the trial was explained and is understood. Also, clinical trial participants are constantly monitored to identify any changes in their condition.

What Is Involved?

The consent:
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.

The study:
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 trail 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
• Research costs

Patient care costs: These are costs associated with providing medical goods and services to each patient. 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: 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. Such costs are usually covered by the sponsoring organization, such as a pharmaceutical company. The sponsor and the participant's health plan need to resolve coverage of these costs for particular trials. Be sure to consult with your physician about the financial aspects of any trial you are evaluating.

Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policies regarding the specific services. In general, the most important factor determining whether something is covered is a health plan's judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exists in sufficient quantity, the plan may label the service as investigational.

Health care services delivered within the setting of a clinical trial are very often categorized as investigational and are not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment.

Health plans may define specific criteria that a trial must meet before extending coverage. Some plans, especially smaller ones, will not cover any costs associated with a clinical trial, while other, larger managed care plans have recently announced at least partial coverage of costs associated with clinical research. Policies vary widely, but in most cases the best strategy is to have a doctor initiate discussions with the health plans.

Medicare Coverage

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:

1. 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.

2. 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.