Clinical Trials 101
CLINICAL TRIALS 101
Shedding light on an oft-misunderstood option

recent study has found that only 35 percent of Americans indicate that they are “likely” to enroll in a clinical trial — while other studies report that only 4 percent of cancer patients enroll in clinical trials nationally each year. Often it’s a lack of understanding about the risks, benefits and opportunities that trials offer that can sometimes prevent patients from taking advantage of the newest drugs and treatments made available. So here we will answer some of the most commonly asked questions about clinical trials:
WHAT IS A CLINICAL TRIAL?
Clinical trials are research studies that allow advances in medicine, identify new treatments and ensure safe and effective care for patients. Carefully conducted clinical trials are the safest way to find new treatments that work; therefore, they are often at the heart of medical advancements. They give enrolled patients the opportunity to be the first to benefit from new treatments, and they advance knowledge and discovery for future patients.
All clinical trials are based on a set of rules called a protocol. A protocol defines:
- The types of people who may participate
- The schedule of tests, procedures, medications and dosages
- The length of the study
While in a clinical trial, participants are seen regularly by the research team to monitor their health and to determine the safety and effectiveness of their treatment. The research team includes doctors and nurses as well as social workers and other health care professionals. A doctor (M.D. or Ph.D.) usually is the clinical trial principal investigator and takes ultimate responsibility for conducting the study. The clinical trial team may include research nurses and study coordinators. These people may coordinate the day-to-day activities of the clinical trial.
For all clinical trials, the research team will:
- Evaluate a participant’s health at the beginning of the trial
- Give specific instructions for participating in the trial
- Monitor participants carefully during the trial
- Stay in touch with the participants
WHO CAN PARTICIPATE IN A CLINICAL TRIAL?
All participants in clinical trials are volunteers. Some of the reasons that people volunteer to participate in clinical trials include:
- To take an active role in their own health care
- To gain access to new treatments that are not available to the public
- To help others by contributing to a broader scope of knowledge
All clinical trials have guidelines about who can participate. Guidelines are based on factors such as age, type of disease, medical history and current medical condition. Before joining a clinical trial, participants must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.
WHERE CAN YOU FIND A CLINICAL TRIAL?
One of the great benefits of receiving cancer care at an academic health center like UF Health is patient access to advanced medical treatment and the latest in research. As an academic health center, our clinician scientists participate in leading-edge research and clinical trials. Patients who are considering learning more about clinical research trials at the UF Health Cancer Center may call 352-273-8675. Patients can also visit ClinicalTrials.gov, a free service of the National Institutes of Health that provides current information about clinical research studies on a wide range of diseases and conditions to patients, their families and caregivers, health care professionals and the public.
CLINICAL TRIAL MYTHS
Dispelling Common Clinical Trial Myths

Clinical trial participants are just human guinea pigs
FACT: Clinical trial patients are partners with their research teams in the process of discovery. They receive some of the best therapies and treatments currently available and get ongoing updates throughout the process. According to the American Cancer Society, patients overwhelmingly rate their clinical trial experiences as positive, saying they were treated with dignity and respect.

Clinical trials are dangerous
FACT: There are federal rules in place to ensure that the rights and welfare of study participants are protected and that clinical trials are conducted safely and ethically. All treatments must first undergo preclinical testing in laboratories. Once treatments are identified as being potentially effective and as not having intolerable side effects, they move into human clinical trials. In addition, potential participants must go through the informed consent process in which the study team fully describes the study, including any possible risks and benefits of participation. Patients are closely monitored by physicians and the research team throughout the study and can choose not to participate at any time. Each trial is also monitored by an institutional review board, or IRB, which is made up of individuals with no connection to the trial, for safety issues.

Clinical trial participants receive sugar pills
FACT: The use of placebos is rare in cancer clinical trials, and placebos are never used in place of standard treatment. Study participants will receive either the best standard treatment for their condition or the new treatment. Sometimes clinical trials compare standard treatment plus the study treatment to standard treatment plus a placebo. Using a placebo in this way can help remove bias from the clinical trial. Study participants will always be informed if the study uses a placebo as part of the study treatment.

Clinical trials are only for people whose other treatment has failed
FACT: Cancer clinical trials differ according to their purpose. They exist for all types and all stages of cancer treatment, as well as for cancer prevention and diagnosis. There are also trials that focus on quality of life factors, managing symptoms of cancer, and side effects of treatment, as well as diagnostic tests or procedures.