FREQUENTLY ASKED QUESTION'S
I HAVE HEARD THAT CLINICAL TRIALS ARE ONLY OFFERED TO PEOPLE AS A LAST RESORT. IS THIS TRUE?
No, Clinical Trials are not just for people with no other options. The studies we conduct here at GMRI are for all kinds of different people in different situations, and with different conditions.
ARE PEOPLE WHO PARTICIPATE IN CLINICAL TRIALS LIKE HUMAN GUINEA PIGS? WILL I BE GAMBLING WITH MY HEALTH IF I PARTICIPATE?
We perform clinical trials to improve the outcome of different conditions, and treatments using methods that have already been rigorously tested before even reaching humans. At GMRI, we conduct Phase II- Phase IV trials, meaning that they have already been tested on small groups of people for safety. For example, some of these trials are on already existing/approved treatments, but they show promise for a different indication, so they need to be tested before they can be prescribed for this new condition.
Participants in Clinical Trials receive very careful medical attention by Doctors and medical staff to ensure their safety and well-being; usually even more attention than that of a regular Doctors Office.
DON'T YOU HAVE ENOUGH VOLUNTEERS ALREADY?
There is actually an extreme need for volunteers for Clinical Trials. More than 70% of studies face delays because they don't get enough participants. Around 30% of trials never end up recruiting anyone. Which means many potential treatments don't even get a chance to be tested. Promising treatments sometimes take more than 10 years to reach the market due to lack of data from volunteers.
DO I HAVE TO PAY OR DO I NEED INSURANCE?
No, most study visits do not charge any fee's to you or your insurance. On the contrary, most studies will offer compensation for your time, travel and effort in helping research progress.
WHAT IS A "PLACEBO-CONTROLLED STUDY"?
A placebo, also known as a sugar pill, is often used in clinical trials as a comparison to determine if the drug being studied is actually effective. By having some of the people take a placebo, we are able to more accurately determine if improvement is due to the medication being studied, or is due to the natural course of the problem being treated. You will not know whether you are on the placebo or on the study drug, nor will the study doctor or staff. Your chances of receiving either are random and assigned by a computer. Regardless of whether you receive the placebo or study drug, the quality of care you receive will be equivalent.
DOES BEING IN A CLINICAL TRIAL BENEFIT THE VOLUNTEER?
Being in a clinical trial may improve your medical condition. At the very least, you will receive medical care from professionals that have expertise in your specific condition. As a participant in a clinical research trial, you will play an active role in your own health care; you may also get extra tests, lab work, and monitoring that you might not otherwise have, as well as having the opportunity to receive a drug that would not otherwise be available to you.
Clinical research participants play a key role in helping scientists find new treatment options that will improve the lives of others living with illnesses and conditions.
IF I JOIN A CLINICAL TRIAL, WILL I GET THE SAME LEVEL OF CARE THAT I RECEIVE WITH MY DOCTOR?
The care people get in a clinical trial is usually excellent. People in trials often say that the trial doctor and staff watch them more closely than their own doctor or nurse does during a regular office visit. This is because trials have very detailed procedures and often include extra tests and extra visits to ensure your safety and track any changes.
WHAT HAPPENS IF I WANT TO DROP OUT?
While we hope that all people who enter a study intend to complete it, you can discontinue at any time. Your participation in any clinical trial is completely voluntary. You can end your participation at any time by notifying us. You will be asked to return all study medication, and come to the office for a final visit, if at all possible.
ONCE I SIGN CONSENT, CAN I STILL DROP-OUT?
The purpose of informed consent is to protect the rights of people taking part in clinical trials. It tells you all about the trial, including activities, visits, and potential risks and benefits. You may leave the trial at any time, but should always let the clinical trial team know first, because some medicines should not be stopped without the doctor’s help.
ARE CLINICAL TRIALS ARE DANGEROUS BECAUSE THEY USE NEW PRACTICES AND MEDICINES?
Keeping trial volunteers safe is the top priority. All clinical trials are reviewed before they start by the Food and Drug Administration (FDA) and an institutional review board (IRB), made up of doctors, scientists, and community members, whose main purpose is to decide if the trial is safe to do. The health and well-being of those that participate in clinical trials is closely monitored and the trial treatments have gone through a rigorous testing process before being given to people.
IF THERE IS A CLINICAL TRIAL THAT COULD HELP ME, WILL MY DOCTOR TELL ME ABOUT IT?
Your doctor may not know about all available clinical trials. If you're interested in one in particular, you're encouraged to discuss it with your Primary Care Provider. Please feel free to have them call us directly if they have any questions about a specific study.
WHY SHOULD I PARTICIPATE?
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. With your help, we can pave the path for future cures.
Being in a clinical trial may also help improve your condition, you may receive treatment and care that you wouldn't otherwise get, & access to healthcare at no cost.