AFCI Clinical Research

Frequently Asked Questions

Clinical trials are often appealing to patients because they offer the opportunity to access new treatments that may prove to be more effective at curing diseases. However, it is important to note that these treatments are not fully tested and there are risks involved. While the potential benefits may outweigh the risks however, Informed Consent is crucial to ensure participants understand what to expect.

Clinical Research FAQ

What is a clinical trial?

A clinical trial is a research study conducted in patients to evaluate a new treatment, medication or device. Participants in clinical trials volunteer to test these innovations in a controlled environment, helping researchers gather data to determine whether the treatment works as intended. The purpose of clinical trials is to find new and improved methods of treating different diseases. Clinical trials make it possible to apply the latest scientific and technological advances to patient care.

Clinical trials are carefully designed, reviewed, and approved before they can begin. They are conducted according to a protocol that outlines the study's goals, the types of patients who can participate, the tests and procedures, the drugs involved, and the length of the study.

Why participate in a clinical trial?

Before a new medical intervention can be approved for use, it must be shown to be safe and effective. Clinical trials are a critical part of this process.

Each clinical trial has a specific "protocol" that describes how it will study the intervention, including how participants will be divided into groups, required site visits and the health outcomes being measured. For instance, participants may be randomly assigned to the experimental intervention, the current standard intervention, or a placebo. The comparison of data from each group is how safety and effectiveness are measured.

During a clinical trial, doctors use the best available treatment as a standard to evaluate new treatments. The new treatments are hoped to be at lease as effective - or possibly more effective than - the standard.

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.

• Treatment Trials test experimental treatments, new combinations of drugs or new approaches to surgery or radiation.
• 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.

What are the phases of clinical trials?

Clinical trials are typically conducted in phases, with each phase designed to assess different aspects of the treatment such as dosage, side effects, and overall effectiveness.

• In Phase I trials, researchers test an experimental drug or treatment in a small group of people (typically 20-80) for the first time. The primary goals are to evaluate its safety, determine a safe dosage range and identify side effects.
• In Phase II trials, the experimental study drug or treatment was found to be safe in the initial Phase I trials, and is given to a larger group of people (100-300) to see to further test effectivenes and evaluate its safety.
• In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness to the standard of care, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.
• In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits and optimal use.

To ensure the results are fair, researchers often randomly assign participants to groups and use a process called "blinding". This means that neither the participants nor the research staff know which intervention each participant is receiving.

How am I protected as a patient in a clinical trial?

Under the regulations of the Food and Drug Administration, Jupiter Medical Center utilizes and Institutional Review Board (IRB) that is designated to review and monitor biomedical research involving human subjects. The purpose of the IRB review is to assure that appropriate steps are taken to protect the rights and welfare of participants in research offered by Jupiter Medical Center and its medical staff. The IRB is composed of physicians, clergy, nurses, lawyers and community leaders. Patients participating in research trials are more closely monitored by their doctors and by the research nurses.

Many clinical trials have a Data Safety Monitoring Board (DSMB), a group of experts that is separate from the company and researchers funning the trial who regularly review trial data. The DSMB can end the trial is the intervention being studied is found to be unsafe or far less effective than the standard of care or placebo. You may always withdraw from the trial at any time if desired, and this will not affect your ability to seek care at Jupiter Medical Center.

Regulatory agencies have strict guidelines that research teams must follow to ensure all patients are treated fairly and safely, and that the trial's potential benefits outweigh risks.

Should I enroll in a clinical trial?

Deciding whether or not to enroll in a clinical trial involves careful consideration between patient and physician. Patient-centered, individualized discussion includes a detailed informed consent, eligibility screening and education of the benefits and possible risks related to the clinical trial. Study participants receive ongoing monitoring and follow-up by the research staff throughout their participation.

If you are living with a medical condition, joining a clinical research trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future.

If you are interested in exploring the trials listed please contact our Clinical Research Office at 561-263-5791.

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