Advancing Cancer Care Through Clinical Research

Clinical trials evaluate the safety and effectiveness of cancer treatments and drugs. They are essential for new or improved therapies to receive approval and become available to patients.

Our goal is to provide patients access to approved and exploratory therapies without the need for long-distance travel. While clinical trials may not be available for every condition, you can discuss your options with your doctor or call (727) 344-6569, ext. 1025, to speak with a member of our research team.

Clinical trials for new cancer treatments follow a structured series of phases. Each phase builds upon the previous one, ensuring that the treatment is safe and effective before advancing further.

• Early Phases (Phase 1 & Phase 2):

  • Assess safety, side effects, and optimal dosage.
  • Determine whether the treatment has a beneficial effect, such as slowing tumor growth.

• Later Phase (Phase 3):

  • Compare the new treatment to the current standard of care.
  • Evaluate effectiveness and safety in a larger patient population.

There are also less common phases:

• Phase 0: A small, early-stage trial that helps researchers decide whether to proceed with Phase 1 testing.
• Phase 4: Conducted after a treatment is approved to monitor long-term safety and effectiveness.

Below is an overview of the most common trial phases:

Phase 1

Purpose:

• Determine a safe dosage.
• Identify the best method of administration (oral, intravenous, etc.).
• Observe how the body responds to the treatment.
  Participants: 15–30 patients.

Phase 2

Purpose:

• Assess whether the treatment is effective against a specific cancer type.
• Continue evaluating its effects on the body.
  Participants: Fewer than 100 patients.

Phase 3

Purpose:

• Compare the new treatment (or a new use of an existing treatment) with the current standard therapy.
  Participants: 100 to several thousand patients.

Some clinical trials use a combined phase design (Phase 1/2 or Phase 2/3 trials) to streamline research. These studies allow for a seamless transition between phases, enabling faster results with fewer participants.

Clinical trials follow strict guidelines to evaluate treatments. These studies are conducted according to predefined protocols that outline the trial’s purpose, procedures, and conduct.

The protocol is developed by the study sponsor, which may be a pharmaceutical company, academic institution, or government agency. It details how the trial will be conducted and who is eligible to participate. All research centers involved must adhere to the same protocol. To protect patient rights and safety, the protocol is also reviewed by an Institutional Review Board (IRB).

Clinical trials are conducted to assess the effectiveness of new cancer treatments. Patients who participate in these trials may benefit in several ways:

• Access to a new drug or treatment procedure. Participants receive either a promising new therapy or the best available standard treatment.
• Early access to innovative treatments if they prove effective.
• The opportunity to contribute to advancements in cancer treatment, helping future patients.

While success is not guaranteed, clinical trials have led to some of the most effective cancer treatments available today.

The benefits and side effects of cancer treatments vary for each patient. To ensure patient safety, strict guidelines are in place for all clinical trials. The research team will discuss any known or potential risks before participation. During the informed consent process, participants receive detailed written information about the safeguards in place before starting any clinical trial therapy.

Consent

Before participating in a clinical trial, you will meet with the study coordinator and the physician overseeing your progress. They will provide a detailed explanation of the study, including potential risks and benefits, alternative options, study duration, required visits, and all necessary procedures, exams, and tests.

If you choose to participate, you must sign an Informed Consent Form, which outlines all aspects of the study and confirms your understanding. Participation is entirely voluntary, and you have the right to withdraw at any time.

The Screening Process

The screening process involves a review of your medical history and current medications. You will undergo necessary exams, tests, and procedures based on the study requirements, as outlined in the initial interview and the Informed Consent Form.

Once all screening tests are completed, eligible participants will proceed with the study. However, some patients may not qualify, and if deemed ineligible, all study-related procedures will be discontinued.

The Study

If you qualify for the trial, you will be assigned study medication according to the schedule provided during your initial interview and outlined in the Informed Consent Form.

Throughout the study, your adherence to the medication regimen will be monitored. You will need to return all medication containers at each visit. Depending on the study, you may also be required to maintain a daily diary and undergo additional tests or procedures.

After the Study

At the study’s conclusion, the study coordinator and physician will perform a final assessment, including a physical exam and collection of any remaining study supplies. They will provide follow-up recommendations if necessary. Additionally, you may be contacted about future studies that match your interests.

Clinical Trial Costs

Participating in a clinical trial involves two types of costs: patient care costs and research costs.

Patient Care Costs

These are the standard medical expenses associated with treating any patient, whether they are part of a clinical trial or receiving conventional treatment. They include:

• Doctor visits
• Hospital stays
• Clinical laboratory tests
• X-rays and other routine medical services

These costs are typically covered by third-party health plans, such as Medicare or private insurance.

Research Costs

Research costs are specific to clinical trial participation and may include:

• Data collection and analysis
• Research physician and nurse time
• Tests performed solely for research purposes

These expenses are generally covered by the trial’s sponsoring organization, such as a pharmaceutical company, academic institution, or government agency. Before enrolling in a trial, discuss the financial aspects with your physician and research coordinator.

Medicare Coverage of Clinical Trials

For the latest information on Medicare coverage for clinical trials, visit www.cms.hhs.gov/ClinicalTrialPolicies to review the Medicare Clinical Trials Quick Reference Guide.

Medicare typically covers cancer treatment and diagnostic trials if:

• The trial is funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups, or other federal agencies funding cancer research. Some other trials may also be eligible, and doctors can request Medicare coverage for patient costs.
• The trial falls within a Medicare benefit category, such as cancer diagnosis and treatment. Cancer prevention trials are not currently covered.

If you are unsure whether a trial is covered by Medicare, consult your doctor. Other covered trials may be available, so it’s essential to evaluate all options before enrolling in an uncovered study.

Medicare continues to cover medical services that are normally included in its benefits, even if they are part of a clinical trial. These include:

• Routine tests, procedures, and doctor visits
• Standard care services used in experimental treatments (e.g., IV administration of a new chemotherapy drug)
• Hospital stays and tests required due to side effects from an experimental drug or treatment

Medicare Non-Covered Costs

Medicare generally does not cover:

• Investigational drugs, treatments, or devices being tested in the trial (though some trial sponsors provide these at no cost)
• Tests, scans, or procedures conducted solely for research purposes, especially if they are required more frequently than standard care
• Items or services already provided for free by the trial sponsor

Before joining a clinical trial, confirm which costs will be covered by Medicare, insurance, or the study sponsor to avoid unexpected expenses.