Q & A
What is a clinical trial?
A clinical trial (also called a research study) is a study in which a person may volunteer to test either a new drug or an already existing and approved drug for an off label or different use. By conducting clinical trials, we learn whether new drugs (also called study drugs) are safe and effective for people to use and properly treat the condition. Existing drugs are also tested for new indications and treatments. These research studies are needed for developing new pharmaceutical drugs, better more effective drugs and better disease management and quality of life. Once the new drug or study drug is found to be safe, effective and approved by the FDA, they become readily available for all other doctors and physicians to prescribe.
Why should you join a clinical trial?
By participating in a clinical trial, you can play a more active role in your own healthcare and have consistent stable management closely supervised by a Doctor and or Physician; which you would not normally get when newly prescribed or started on a medication. You would gain insight and access to new research treatments before they are widely available and help others by contributing to the advancement of medicine. We all benefit when people step up and volunteer to participate in clinical research studies.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes Doctors and Nurses as well as other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Why? Because Clinical Trials are at the heart of all medical advances, and participants are essential to clinical trails. So, we go beyond to treat and care for our Study participants.
For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact between the patient and the research staff. Volunteers should feel free at all times to ask as many questions as they need to make things clear.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the Research and HealthCare team know about it, and supply the reasons for their desire to leave and no longer participate in the study with absolutely no obligation, repercussion or penalty for exiting from the study.
Who Can Participate?
All Clinical Studies have guidelines about who can participate. Patients may be selected based on the type and stage of a disease, previous treatment history, and other medical conditions. Clinical Researchers often look for people of different ethnicities, races, ages and sexes. The Study sometimes require adequate representation from a variety of people, so they can make sure to develop appropriate treatment(s).
Some disorders affect certain groups of people more than others, so it's especially important to have clinical research patients from the at-risk or affected population. There are studies that have found that certain racial or ethnic populations may "metabolize" or handle drugs in different ways.
The Selection Criteria helps to ensure that researchers are studying the right people to help find answers to important medical questions. Having a variety of patients allows researchers to determine the proper treatments and doses for different types of people.
