top of page
-
Why participate in clinical research trials?Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
-
How much will it cost me to participate?It costs nothing. Nothing at all. In fact, compensation for your time and travel is typically paid to YOU. It is easy to assume there is a cost associated with clinical research. After all, you are receiving medications that are not even available to the public yet that might treat a specific ailment you have. However, there is no cost at all. In fact, insurance is not required. Insurance is never filed. We do not even need your insurance information at all.
-
Do I need to have insurance to participate?Insurance is not required. Insurance is never filed. In fact, we do not need your insurance information at all. That is why clinical research is often a good option for those without insurance. With each study, you receive the study medication, lab tests, physicals from a certified physician and study team while you are in the study. Some studies will provide MRI’s, Xray or Bone Density scan. If you do not have insurance, clinical research provides another avenue to receive medical care under an experienced medical team. If you do not have insurance, clinical research provides another avenue to receive medical care under an experienced medical team.
-
What happens during a clinical research trial?The clinical trial process depends on the kind of trial being conducted (See "What are the different types of clinical trials?") The clinical trial team includes doctors and nurses as well as social workers and other healthcare 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. 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 with the research staff.
-
What if I participate in a study and then change my mind and want to quit?You can quit a clinical research study at any time.
-
When and how do I get paid?At AMR, all study volunteers receive a debit card that can be loaded by the AMR staff. Once you have completed your first paid visit, your compensation is added to the debit card. Some locations will be sure the funds are available upon arrival at your next visit. Some AMR locations also have referral programs that can range from $50 to $100. When you refer a friend to us and they qualify / randomize in a study, you will be paid for that referral. Typically, this is done by mail and a check is sent to you.
-
What are the phases of clinical research trials?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, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. Phase IV trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time. Phase IV clinical trials may include thousands of people. They are also referred to as post-marketing surveillance trial.
-
What are the benefits and risks of being in a clinical trial?Benefits: Clinical trials that are well-designed and well-executed are the best approach for eligible participants to: -Play an active role in their own health care. -Gain access to new research treatments before they are widely available. -Obtain expert medical care at leading healthcare facilities during the trial. -Help others by contributing to medical research. Risks: There are risks to clinical trials. -There may be unpleasant, serious or even life-threatening side effects to experimental treatment. -The experimental treatment may not be effective for the participant. -The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements. With each study, you receive the study medication, lab tests, physicals from a certified physician and study team while you are in the study. Some studies will provide MRI’s, Xray or Bone Density scan. If you do not have insurance, clinical research provides another avenue to receive medical care under an experienced medical team.
-
If medicine is tested for safety, why is there such a long list of complications and reactions to medicine once it is on the market?"Commercials for new medicine (and the disclaimer that comes when you fill a prescription) can be scary. However, the list of possible reactions and side effects is required and that list was most likely compiled through results from a clinical research trial. If 3,000 volunteers participate in a trial and even ten of them suffer the same side effect (and 2,990 did not), the side effect must be listed. Please keep in mind that not all side effects are equal. Many trials - especially healthy volunteer trials - require the volunteer to keep a daily diary during an indicated period of the trial. Typically, the volunteer rates his or her physical state, records his or her temperature and has to do so at approximately the same time every day during the indicated period. Other factors can be present that could possibly create a reaction. Example: volunteer has a fever unrelated to the clinical trial study drug but has to record that fever regardless.
-
How is the safety of the participant protected?The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated 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 secret and will not be mentioned in these reports. There are guidelines and governmental departments that require safe practices for clinical research trials. The principal investigator of each clinical research study is the person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site. In most cases the principal investigator will be a leading physician in the disease area being studied. Our goal is to provide the highest standards of care overseen by a licensed Physician. You will be monitored by experienced, qualified medical professionals throughout the study.
-
Will the medication be available to me after the study?Each study is different. And each study sponsor (the providing drug company whose medicine is being studied) has different policies regarding medication. The easy answer is "no." No, you do not get the medication after the study as it has not yet gone through the entire FDA process. However, many study sponsors will allow volunteers to keep the remaining medication - if there is any. For example, if you are in a migraine study and are only asked to take the migraine medicine during a migraine, you may have medication left over when the study ends. Depending on the study sponsor, you may be able to keep the rest. In other studies, you are asked to turn in all un-used medication.
-
Can I do more than one study at a time?No. However, once your study is complete, you can immediately contact our recruitment specialists to see if there are any new studies that you can participate in.
-
Why is the first visit so long?The length of the initial visit varies by study. However, expect a minimum of two hours. That is because you will be given the Informed Consent to read. The Informed Consent tells you all the details about the study. Length of the study, your role in the study, the expectations, side effects, what is required of you, how many visits there are, what the compensation is and what is being studied / tested, etc. You will also be given "directions" as to how to participate. You will then meet with a clinical research coordinator and discuss any questions you have about the Informed Consent. If you agree to the terms of the clinical study, you will sign the Informed Consent with a clinical research coordinator or assistant in the room. You will then have a physical and lab work required to get you in the study. If you are participating in a vaccine study, you may receive the vaccine on your first visit. If so, your vitals will be taken approximately 15 to 30 minutes after you receive the vaccine. You will also be in what many of our locations call a "diary room." We basically observe you during that time period before we take your vitals. We also explain how you will need to complete the diary that is often required with many clinical research studies. After the initial visit, follow-up phone calls and follow-up visits will be much quicker to complete.
-
When do I find out if I received the placebo in the study?Unfortunately, that is not up to us. The study sponsor determines when - or even IF - the study volunteers get to learn if they received placebo or not. Typically, if we are allowed to tell you, that happens after the study is complete - sometimes several months after. Once you have completed a study, you are always welcome to call us to ask if you have not yet been told. However, please know that often times, the sponsor does not allow us to share this information. When we are able, we are more than willing to tell you.
1928 Alcoa Hwy, Suite B107, Knoxville, TN 37920
bottom of page