A clinical trial is a research study in human volunteers intended to answer a particular health questions. After a medicine or treatment is found to be safe and efficient, the FDA may approve it, and then, it will be available for the general population.
No treatment may reach clinical testing unless there is evidence that there might be an improvement over current therapies, as well as safety measures being met.
Medical treatment cannot improve without research and volunteers. Everyone would like a successful treatment available when diagnosed with an illness. By volunteering for a clinical trial, you can help advance knowledge about future treatments that someday you and a loved one may benefit from.
In a research study, you have the ability to take an active role in your health. You receive access to investigational medications and treatments before they are widely available, and you can help others by contributing to the approval of new therapies.
All clinical trials at Research Centers of America and elsewhere have guidelines about who can enter into a particular study. The factors that permit someone to participate in a clinical trial are called “inclusion criteria, ” and those that prevent someone from participating are called “exclusion criteria.”
These criteria factors include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. To join a clinical trial at Research Centers of America, a participant must meet the requirements for the study. Inclusion and exclusion criteria are used to identify proper participants and keep them safe. The criteria help ensure that research questions will be answered accurately.
The clinical trial process depends on the kind of test being conducted. The clinical trial team includes doctors, nurses and other health care professionals. These clinicians 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 at Research Centers of America include more tests and doctor visits than you would normally have for illness or condition. Your participation in clinical trials will be more safe and fruitful if you follow the protocol carefully and stay in contact with research staff.
Informed consent is the process of learning the key facts about a study including its purpose, duration, required procedures, risks, and benefits. You should always ask for the consent documents in a language you are comfortable with. Joining a clinical trial is a critical decision so, you must ask the research team any questions you may have about the study and the consent forms before you decide to participate. After your questions are answered, you should sign the consent and receive a copy. Your participation is voluntary, and you can stop participating at any time.
Taking part in a clinical trial can have many advantages:
The FDA federally regulates all trials at Research Centers of America with built in safeguards to protect the participants. The 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 anonymous and will not be mentioned in these reports.
It is essential that you know as much as possible about clinical trials so that you can make an informed decision as to whether or not you want to participate in clinical trials in Research Centers of America.
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: