About Clinical Trials
UF Health Jacksonville, affiliated with the
University of Florida Health Science Center Jacksonville, offers all the
benefits of an academic health center, including advanced medical treatment and
the latest in research.
As an academic health center, faculty 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?
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.
What is a research team?
The research team includes doctors and nurses as well as social workers and other
healthcare professionals. A doctor (M.D. or PhD.) 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
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.
What is a protocol?
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.
What protections are in place for people who participate
in clinical trials?
The government has 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.
What is informed consent?
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:
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- 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
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:
- 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.
Where can I find a clinical trial?
Where can I learn more about clinical trials?