Clinical Trial FAQ
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 cutting-edge research and clinical trials. Clinical trials are research studies that allow advances in medicine, identify new treatments and ensure safe and effective care for patients.
Patients who are considering participation in clinical research trials are encouraged to review the following information:
- What is a clinical trial?
- What is a research team?
- What is a protocol?
- What protections are in place for people who participate in clinical trials?
- What is informed consent?
- Who can participate in a clinical trial?
- What do I need to know if I am thinking about participating?
- Where can I find a clinical trial?
- Where can I learn more about clinical trials?
A clinical trial is a research study conducted with patients to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the safest way to find new treatments that work.
The research team includes doctors and nurses as well as social workers and other healthcare professionals. A doctor (M.D. or Ph.D.) usually is the clinical trial principal investigator and takes ultimate responsibility for conducting the study. Frequently, a clinical trial will have a research coordinator or study coordinator working on the team. This person 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 after the study
Participants should learn as much as possible about the clinical trial they are considering. The research team can provide answers to any questions.
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 government and the University of Florida have strict guidelines and safeguards to ensure the well-being of people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is an independent committee of physicians, statisticians, community advocates and others that ensures a clinical trial is ethical and the rights of participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Informed consent is the full disclosure of important facts about the clinical trial before a decision is made whether or not to participate. The research staff will give potential study participants the details about the study, including:
- Why the research is being done
- What the researchers want to accomplish
- What will be done during the trial and for how long
- What risks are involved in the trial
- What benefits can be expected from the trial
- What other treatments are available
- Informing study participants that they have the right to leave the trial at any time
All participants in clinical trials are volunteers. Some of the reasons that people volunteer to participate in clinical trials:
- To take an active role in their own healthcare
- To gain access to new treatments that are not available to the public
- To obtain expert medical care at leading healthcare facilities during the trial
- To help others by contributing to a broader scope of knowledge
All clinical trials have guidelines about who can participate. Guidelines are based on such factors 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.
- Participating in Clinical Trials – NIH
- Educational Materials About Clinical Trials – National Cancer Institute