- *Cancer Care Clinical Trials
- Sarasota Memorial Institute for Cancer Care
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Sarasota Memorial’s Cancer Research Department and partnership with community physician offices provide patients with access to the latest clinical treatment trials and tissue bank protocols, while being treated in their own communities.
Our research studies encompass large-scale studies in multiple sites across the nation involving thousands of patients. We provide the community a variety of trials, including pharmaceutical, biologic, blood, tissue and quality of life studies. The research department includes Certified Research staff who specialize in coordinating care and providing the attention to detail required for safe patient care. Our physicians are trained prior to participating in research trials in order to better educate and support their patients. Sarasota Memorial’s Institutional Review Board and the U.S. National Institutes of Health review all clinical trials to ensure safe and ethical research standards are followed.
A Personal Decision.
Patients who qualify for clinical trials should decide whether to participate in a study only after discussing the risks, benefits and options with their doctor. No one is placed in a clinical trial without his/her knowledge and consent.
If you or your doctor would like to learn more about relevant clinical trials you might participate in, contact us at:
Cancer Care Clinical Trial Department
Sarasota Memorial Hospital
1700 South Tamiami Trail Sarasota, Fl 34239
Phone: (941) 917-6519
Fax: (941) 917-3134
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.