Cancer clinical trials

A clinical trial is a research study involving human volunteers in an effort to answer specific health questions. All trials are carefully conducted and are the safest and fastest way to find effective treatments and new ways to improve health.

Clinical studies are performed to establish evidence-based medicine, and many of the standard treatments and therapies used today are possible due to this research.

There is great probability that you or a loved one will be affected by an acute or chronic illness at some point. Clinical studies are thoughtfully designed and administered by our hospital's research team in an effort to answer specific medical questions. Now, our patients no longer need to leave our community to find the clinical study that is appropriate for them.

Clinical trials are used to test therapies, medications, patient groups and more. These studies involve different protocols and go through a range of phases. Eligibility depends on the type and phase of the trial. Patient privacy is critical, and information discovered in a clinical trial is kept as confidential as possible.

Clinical trials are conducted according to a plan called a protocol. A protocol describes what types of patients may enter the study, schedules of tests and procedures, what drugs/devices are involved, dosages, length of study and outcomes to be measured. Each person participating in the study must agree to follow the protocol.

Clinical trials are often used to test the following:

• To determine which existing treatments are best
• To learn how to use the treatment in a different population, such as children, in whom the treatment was not previously tested
• To see if a new drug or device is safe and effective
• To study different ways to use standard (approved) treatments, so they will be more effective, easier to use and/or decrease side effects

Most clinical research that involves the testing of a new drug progress in an orderly series of steps called phases. This allows researchers to ask and answer questions in ways that result in reliable information about the drug and protects the patients.

Clinical trials are usually classified into one of four phases:

• Phase I Trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
• Phase II Trials: A phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular disease.
• Phase III Trials: These studies test a new drug, a new combination of drugs or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices and clinics nationwide.
• Phase IV trials: Phase IV trials are also known as Post Marketing Surveillance Trials. They involve the safety surveillance and ongoing technical support of a drug after it is permitted to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population over an extended time period that was not possible during the Phase I-III clinical trials.

Each study follows specific guidelines for participation. Generally, eligible patients are alike in key ways, such as age, gender and the type of disease they have.

Patient information and a person's participation in a research study are kept as confidential as possible. Therefore, information is given only to those who have permission. This may include the group sponsoring the study and those responsible for the study's safety and that it follows protocol.

Researchers review and analyze data collected during the study. Results of studies are sometimes published in medical journals. In these cases, patient identities are not revealed.

Some studies are reviewed by the Food and Drug Administration (FDA). These studies require participants to sign a study consent allowing the researchers access to their data.

To receive the most up-to-date information and access to screening for appropriate trials, please contact our clinical research department:

Tonnica Sasanas, RN, BSN — Clinical Research Coordinator

HCA Florida JFK Hospital Comprehensive Cancer Institute
4685 South Congress Ave.
Lake Worth, FL 33461
Phone: (561) 548-1877
Fax: (561) 548-1633
Email: Tonnica Sasanas, RN, BSN

Jill Kinley, APRN, MSN, CCRC—Director of Clinical Research

HCA Florida JFK Hospital, HCA Florida JFK North Hospital, HCA Florida Palms West Hospital
5301 S. Congress Ave.
Atlantis, FL 33462
Office: (561) 548-1414
Cell: (561) 319-9024
Fax: (561) 548-1719
Email: Jill Kinley, APRN, MSN, CCRC

HCA Florida JFK Hospital is a participant in the Center for Information and Study on Clinical Research Participation (CISRP). This independent non-profit organization was founded to educate the public, patients, medical/research communities, media and policymakers to promote greater understanding and awareness of clinical research participation and the role it plays in public health.

Center for Information and Study on Clinical Research Participation (CISRP).

For more information about the CISRP, call (877) 633-4376, (877) MED-HERO.

HCA Florida JFK Hospital is also affiliated with the Western Institutional Review Board, Inc. (WESTERN IRB), which is registered with the federal government and provides review and approval of clinical studies performed at our hospital.

The JFK Comprehensive Cancer Institute at HCA Florida JFK Hospital has become an Affiliate Member of the Cleveland Clinic Foundation for the Radiation Therapy Oncology Group (RTOG). Being a participating member of the RTOG is both a great honor and responsibility. This membership provides our patients access to national clinical trials not available via any other source. We hope that this enhances the opportunity for our Cancer Institute to provide patients the very best in clinical research opportunities.

It is always a patient's choice to participate in a clinical trial without affecting their standard care. Patients are also allowed to change their minds at any time once they are involved in a study.

The trials that we participate in predominantly require hospitalization for the disease being studied. During a patient's hospital stay, their physician determines if there is a study that would enhance their care.

Since 1993, HCA Florida JFK Hospital has been involved in clinical trials, and since then, well over 300 trials have been conducted at our facility. If appropriate trials are available, we are able to provide our patients with clinical studies.

For patients being treated for cancer, we have many trials to choose from to ensure our patient's specific needs are met.

We are also members of NRG Oncology — the research subsidiary of the National Institutes of Health. This allows us access to all of the NIH-sponsored trials.

Many of our physicians on staff are involved in research and clinical trials on an outpatient basis in their private practices. The research department can assist patients in finding trials that are appropriate for their situations.

The Research Department at HCA Florida JFK Hospital conducts the following five types of clinical trials:

• Diagnostic trials — Studies conducted to find better tests or procedures for diagnosing a particular disease or condition
• Prevention trials— Studies that test new approaches to prevent disease or to prevent a disease from returning, including medicines, vaccines, vitamins, minerals or lifestyle changes
• Quality of life trials — Studies that explore ways to improve comfort and the quality of life for individuals with chronic illnesses
• Screening trials — Studies that test the best way to detect certain diseases or health conditions earlier
• Treatment trials — Studies that test experimental treatments, new combinations of drugs, devices or new approaches

Participation in clinical trials is completely voluntary. Each patient must determine if participation is a viable option for their unique condition There are a wide range of potential benefits and risks of participation that should be considered.

Potential benefits of clinical studies include:

• Access to potentially new research treatments
• Receiving expert medical care from the investigators (physicians) are often specialists in the disease being studied
• The opportunity to help others by contributing to medical research and treatment advances

Potential risks of clinical studies include:

• Demanding and time-consuming participation
• Ineffective treatments
• Unpleasant, serious, or even life-threatening side effects resulting from treatment

Many safeguards are in place to make clinical trials as safe as possible and protect patients. Therapies are carefully studied in the lab long before a human being ever receives a new therapy. Any clinical trial involving people must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists, administrators and members of the public. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure the protection of the rights and welfare of patients who are enrolled in clinical trials.

Institutional Review Board (IRB)keyboard_arrow_right

U.S. Food and Drug Administration (FDA) keyboard_arrow_right