A Personal Decision.

A clinical trial is an important personal decision. It is often helpful to talk to a physician to learn about options available in the region. Sarasota Memorial’s Clinical Research Center and partnership with the Moffitt Cancer Center provide patients with access to the latest treatment protocols and clinical trials, while being treated at home, in their own communities.

Our research studies typically are Phase 3 and Phase 4 trials, which encompass large-scale studies in sites across the nation involving thousands of patients. At this level of research, drugs or devices under study have already passed safety standards established in Phase 1 and Phase 2 trials and are seeking FDA authorization for specific use and indications.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

How is participant safety protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect participants. Each trial follows a carefully controlled protocol, a study plan that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.

What are the benefits and risks of participating in a clinical trial?

Benefits: Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research. Risks: There are risks to clinical trials.
• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are the different types of clinical trials?

• Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins,  minerals,  or  lifestyle  changes.
• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
• Tissue trials study tissue samples to determine how variations in human genes affect the response to medications.

James Fiorica, MD

Noted researcher and gynecologic oncologist James Fiorica, MD, heads Sarasota Memorial’s Women’s Cancer Specialty Program. Board-certified in obstetrics and gynecology with a gynecologic oncology subspecialty, Dr. Fiorica is principal investigator of ongoing clinical studies sponsored by the National Cancer Institute and national Gynecologic Oncology Group and a pioneer of a number of new techniques to screen and treat women’s cancer. He can be reached at Sarasota Memorial’s First Physicians Group: (941) 917-8383.

The Institute has been accredited with commendation from the American College of Surgeons Commission on Cancer (CoC) – the highest level of accreditation awarded in the nation.

Total Cancer Care Program^™ Sarasota Memorial and the Moffitt Cancer Center have recently joined forces in a clinical study exploring a new frontier in cancer research – one doctors hope will lead to more advanced treatments, possibly even personalized cures for the disease.

Just as every individual has a different fingerprint, every tumor is unique. While researchers know that cancer can be classified by its site of origin (lung, breast, colon, prostate, etc.), there are, in fact, many different types of each of these cancers, and people with the same kinds of cancer sometimes respond differently to standardized treatments.

Only recently has technology advanced enough so that researchers can now test each tumor for approximately 30,000 genes. These genes provide a molecular fingerprint unique to each tumor, just as the lines on a fingerprint uniquely identify an individual.

With the permission of patients, doctors study the molecular fingerprints for each individual’s cancer and enter information from the genetic experiments into a large central database. By comparing data on individual cancers and recording successful treatment outcomes, scientists hope to develop new drug therapies that are personalized for each individual.

It will take the participation of thousands of patients to make TCC work. Physicians and staff at Moffitt, Sarasota Memorial and 16 other hospitals across the nation are collecting survey data and tumor tissue samples from as many cancer patients as possible.

People who participate in Total Cancer Care^™ may also benefit from access to individualized clinical trials as they develop and new medicines as they become available. There are no extra doctor visits, no additional expenses to pay and, in accordance with HIPAA regulations, all medical information remains private.

How You Can Participate
A small investment of time is all it takes to become a participant in Total Cancer Care™. Consider spending an extra 30 minutes when you visit your physician to answer a few survey questions about your medical history. If a biopsy is recommended, a portion of the tissue removed will be submitted for research.

If surgery is needed, cancer tissue that normally would be discarded is sent to researchers for analysis. Patients can elect to withdraw from the study at any time; however, researchers would like to follow you for life. For information, call Sarasota Memorial’s Total Cancer Care^™ office at (941) 917-2227.