FREQUENTLY ASKED QUESTIONS
What is a clinical trial?
A clinical trial is a research study in human volunteers intended to answer particular health questions. Clinical trials at South Florida Advanced Clinical Research Network are conducted to develop new medications or treatments that can improve health. After a medication or treatment is found to be safe and effective, it may be approved by the FDA and then, it will be available for population.
No treatment may reach clinical testing unless there is evidence that there might be an improvement over current therapies.
Why participate in a clinical trial?
Medical treatment cannot improve without research and volunteers. Everyone would like a successful treatment available when diagnosed with an illness. By volunteering for clinical trials in Miami you can help advance knowledge about future treatments that someday you and a loved one may benefit from. In a research study in clinical trials in Miami you have the ability to take an active role in your own health, access possible investigational medications/treatments before they are widely available, and help others by contributing to the participants in return for their time and travel.
Who can participate in a clinical trial?
All clinical trials in Miami and elsewhere have guidelines about who can get into a specific study. The factors that permit someone to participate in a clinical trial are called “inclusion criteria” and those that forbid someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. In order to join clinical trials Miami, a participant must meet the requirements for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. Inclusion and exclusion criteria are used to identify proper participants and keep them safe. The criteria help ensure that research questions will be answered properly.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team, whether conducted at medical clinics in Miami or elsewhere, includes doctors, nurses and other health care professionals. These professionals will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials Miami include more tests and doctor visits than you would normally have for an illness or condition. Your participation Miami clinical trials will be more successful if you follow the protocol carefully and stay in contact with research staff.
What is informed consent?
Informed consent is the process of learning the key facts such as its purpose, duration, required procedures, and key contacts about a clinical trial, before deciding whether or not to participate. When you decide to join a clinical trial you will receive an informed consent document that includes the details about the Study. You can always ask for the consent documents in different languages other than English. Joying a clinical trial is a very important decision so, you must ask the research team any questions you may have about the study and the consent forms before you make a decision.
What are the benefits of participating in a clinical trial?
Besides playing an active role in your own health care and helping others by contributing to medical research, by participating in South Florida clinical trials you can also enjoy benefits like:
Have access to new medical treatments or medications that are not available in the market or in medical clinics in Miami.
Obtain medical care at top health care facilities during the trial.
If you qualify you may receive a stipend to help compensate for time and travel.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to Miami clinical trials and most of the Miami clinical trials are federally regulated with built in safeguards to protect the participants. The trial, including each South Florida clinical trial, follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.
What questions should I ask?
It is very important that you know as much as possible about South Florida clinical trials so that you can make an informed decision as to whether or not you want to participate if you are interested in participating in clinical trials in Miami. The following questions might be helpful for you and some of the answers to these questions are found in the informed consent document.
What is the purpose of the study?
Why do researchers believe the new treatment being tested may be effective?
Has it been tested before?
What kinds of tests and treatments are involved?
How do the possible risks, side effects,and benefits in the study compare with my current treatment?
How might this trial affect my daily life?
How long will the trial last?
Who will pay for the treatment?
Will I be reimbursed for other expenses?
What type of long-term follow up care is part of this study?
How will I know that the treatment is working?
Will results of the trials be provided to me?
Who will be in charge of my care?
What are the different phases of a Clinical Trial?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, a new drug or treatment is tested in a small group of people (20-80) for the first time to evaluate its safety. Phase I also help to determine a safe dosage range, and identify side effects.
Phase II trials are conducted on a larger group of people (100-300) to evaluate its effectiveness and to further evaluate its safety and dosage for people who suffer from a specific condition.
Phase III trials are conducted on very large groups of people (1,000-3,000) and are designed to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV trials are post marketing studies that delineate additional information including the drug’s risks, benefits, and optimal use. Some of these Phase IV trials are conducted at Medical Clinics in Miami.