What is a Clinical Trial?
The National Institutes of Health (NIH) defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions. Clinical trials (intervention studies) are clinical research studies that look at new ways to understand, prevent, detect, or treat disease. Intervention studies include therapeutic, intervention prevention and intervention supportive care studies. Treatments might be new drugs or combinations of drugs, new surgical procedures or devices, or novel ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment is effective and safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for patients with chronic illnesses. Clinical trials are part of medical research and they are at the center of medical progress and advances.
Cancer-related clinical research studies include, but are not limited to, clinical trials (intervention studies). Non-intervention studies are also clinical research studies carried among cancer patients and healthy populations, but involve no intervention or alteration in the status of the participants. These non-intervention studies include non-intervention prevention, non-intervention supportive care, epidemiologic, observational, correlative, early detection, screening, diagnostic, outcomes or ancillary studies. Examples of these studies are surveillance, risk assessment, outcome, environmental, and behavioral studies.
What Are the Different Types of Clinical Research Studies?
Clinical Trials (intervention studies) enroll patients and provide a specific treatment (therapeutic) or intervention to the patients to study its impact and effectiveness on cancer. Examples of these intervention studies are:
- Prevention Trials – Test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer, or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer.
- Screening Trials – Test the best way to find or locate cancer, especially in its early stages.
- Diagnosis Trials – Test new methods for diagnosing cancer.
- Treatment Trials – Test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).
- Coping with Cancer Trials (also called Quality of life or Supportive care trials) – Explore ways to improve comfort and quality of life for cancer patients by evaluating ways of helping with the side effects of treatments.
Clinical Research (non-intervention studies) do not provide a treatment to patients (non-therapeutic), but instead study important factors which help advance the understanding of cancer and its impact. Non-intervention (non-therapeutic) studies often lead to therapeutic ones. Specific examples of non-therapeutic research studies are:
- Collection of tissue specimens to examine the cellular structure of a cancer tumor
- Studies that track epidemiological information such as the long-term health effects of chemotherapy
Clinical Research at Sylvester
Translating research breakthroughs into more effective treatments remains one of Sylvester’s highest priorities. Sylvester conducts more clinical research than any other institution in South Florida and has a wide range of clinical trials, with 259 clinical trials currently underway. The Phase I Clinical Trials Program at Sylvester is South Florida’s only academic Phase I testing center dedicated to drug development for cancer patients. Sylvester also has the only Pediatric Phase I Clinical Trials Program in South Florida.
To search for specific cancer clinical trials, click HERE » and Browse by Division/Therapeutic Area.
For information on Understanding Clinical Trials, click » HERE
For more information, view our Clinical Trials FAQs or call the Sylvester Information Center at 305-243-1000 or 800-545-2292.