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Q: What is the purpose of clinical research?
A: The purpose of clinical research is to determine how new medications and treatments work on people. By conducting clinical trials or studies, doctors help discover new and different ways to detect, diagnose, control, treat, and even prevent illnesses. Before a new medication or treatment is approved for use by the public, it is necessary to test it in great detail according to the strict rules and regulations of the U.S. Food and Drug Administration (FDA).
Q: What goes on during a clinical trial?
A: During a clinical trial you will work with a research team in a doctor’s office. Members of the team include doctors, nurses, research coordinators, and other health care professionals. You will first be called in for an office visit to see if you qualify for the study. If you qualify, all the medical visits you make relating to the study will be free of cost to you. These visits may include: physical exams, doctor visits, study medications, laboratory tests, etc. The amount of visits required will vary depending on the specific trial.
Q: Why should I participate in a clinical trial?
A: Volunteering to be involved in a clinical trial comes with many benefits: Free healthcare by qualified medical personnel, including doctor visits and study medication
Having access to new medications and treatments before being available to the public
Contributing to the advancement of new medications and technology in the healthcare industry
Providing beneficial research to improve the quality of life your children, grandchildren, and future generations
Q: How will I be protected during the clinical trial?
A: Patient safety and well-being is the number one priority of DynaMed. Before participating in any aspect of the clinical trial, a healthcare professional will review with you the Informed Consent. If you agree to participate in the trial, you must agree to and sign this form. The Informed Consent lists details of the trial, including possible risks. Throughout the trial, you will be under the care of an experienced physician who has been trained and designated as the Principal Investigator of the trial. Furthermore, before studies are made available to the public, they must be approved by an Institutional Review Board (IRB). IRB approval is required by the FDA to make sure that the rights and well-being of patients participating in clinical trials are protected. It is important to note that agreeing to participate in a clinical trial is completely voluntary and you are free to leave the study at any time if you so desire.
Q: If I decide to volunteer to participate in a clinical trial, what are some of the questions I should
ask before consenting?
A: There are several questions you may wish to consider before enrolling in a clinical trial (Some of these questions may be answered in the Informed Consent):
What is the purpose of this trial?
How long will this trial last?
Which treatments will be used in this trial and how?
Are there any risks involved in participating in this trial?
What kind of tests and treatments are involved in this trial?
Who will pay for the treatment involved in this trial?
Will I be reimbursed financially for participating in this trial?
Who will be in charge of my care during the trial?
How will this trial affect my daily life?
Q: Who is eligible to participate in clinical trials and how are they selected? A: Each clinical trial has a set of inclusion and exclusion criteria. To be eligible to participate, you must meet the requirements of both sets of criteria. Inclusion criteria are factors that you must possess in order to be accepted into the trial. Exclusion criteria are factors which you must not possess in order to be eligible to participate in the trial – If you possess any of the factors from the exclusion criteria, you may be excluded from participating in the trial.
Q: Will I get paid to participate in the trial? A: Most studies will reimburse patients for participating in the trial. Reimbursement is for the purpose of the patients’ time and travel expenses.
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