Why should you participate in a clinical trial?
Clinical trials are research studies intended to develop new treatments for medical conditions. We often conduct clinical trials with medical devices. However, most of our research involves investigations into the safety and effectiveness of drug treatments. Our goal is to determine if new treatments are safe, and if they work. As the result of our research work for the past several decades, and as the result of the dedication of our study volunteers, we have helped develop some of the most common drugs being used today.
Volunteers who participate in our clinical trials may receive study-related procedures such as medical evaluations, physical exams, laboratory/blood testing, dietitian visits, electrocardiograms, other diagnostic tests, and study drug - all without charge. While variable from study to study, our volunteers may also receive reimbursement for time and travel.
Some of the reasons our study volunteers participate in clinical trials is because they appreciate the one-on-one opportunity to discuss their health issues with a trained and caring health professional. Other study volunteers enjoy the social atmosphere of being part of the research family. But perhaps the most important reason our study volunteers participate in clinical trials is to assist us in the research and development of investigational medications/drugs. Our volunteers recognize their efforts may result in the development of safer and more effective treatments than what is currently available. In this way, our volunteers find participation in clinical trials an enjoyable and rewarding experience.
How can you benefit from participating in a clinical trial?
L-MARC Research Center is not a free treatment center. Our primary focus is clinical research. Most of our clinical trials involve drugs that have yet to be proven effective or safe. Many of our clinical trials compare study drug to placebo (or “dummy” pills). Therefore, volunteers may not be guaranteed they will be on active treatment, sometimes throughout the entire clinical trial.
Even with these considerations, our study volunteers often feel they benefit from participation in clinical trials. The safety monitoring procedures (e.g., study-related medical evaluations, physical exams, laboratory/blood testing, dietitian visits, electrocardiograms, and other potential diagnostic tests) often represent a level of evaluation that exceeds what a health insurance company might approve, or what our volunteers may receive by going to their primary care clinician. As a result, many (if not most) of the abnormalities we find are unrelated to the study drug. In other words, because we evaluate our study volunteers to a degree that is specified by a study protocol, we often discover medical issues that would have otherwise gone undetected. Once these previously undetected abnormalities are found, the study volunteer and the study volunteer’s clinician are notified for further evaluation and treatment.
How do you qualify for a clinical trial?
Firstly, you must have a medical condition that requires a treatment we are studying. Secondly, you must meet inclusion criteria, while avoiding exclusion criteria. Thirdly, you must carefully undergo an informed consent process to ensure this is something you really want to do, and are really committed to complete. Finally, if you agree to participate in a clinical trial by signing an informed consent document, then you will likely receive an evaluation including laboratory testing and clinical exams. Afterwards, if you continue to qualify, then you may receive study drug administration.
NOTE: You cannot change any aspect of your medical care, nor can you undergo any study-related procedures until you undergo an informed consent process and sign an informed consent document.
What happens when the clinical trial is over?
Once you have completed your participation in a clinical trial, you will receive an “exit letter” that will briefly describe the study again, and will list conditions or medical issues that were found during your participation. Although the majority of these conditions and medical issues will likely be unrelated to the study drug, we feel it is important that you be provided this letter. With your permission, a copy will also be sent to your treating clinician/s for your medical records.
What are the to ten things to remember if you agree to participate in a clinical trial?
(1) Always notify your research coordinator of all your medications, including over-the-counter medications, supplements, vitamins, herbs, birth control pills, and hormones.
(2) Many medications may interact with study drugs, or may alter blood tests. Therefore, if you are developing a condition that you feel might require medication treatment (even if over-the-counter), then please contact your research coordinator as soon as possible. For example, if you are developing an illness on Friday, please call your research coordinator on Friday. Please do not try to “tough it out” over the weekend.
(3) Strenuous physical activity can alter muscle blood tests. Alcohol can alter liver blood tests. Therefore, during your participation in a clinical trial, please try to avoid unusually strenuous exercise and excessive alcohol within two days of having your blood drawn.
(4) Many (but not all) clinical trials require that your diet and exercise remain constant throughout the duration of the clinical trial. Therefore, while you may often receive nutritional and lifestyle counseling, once you start the study, you may also be asked to maintain your diet and exercise throughout the study.
(5) Office visits and laboratory visits often have to be performed at precise time periods. You will need to plan these visits into your schedule. If you are unable to keep an appointment, then please contact your research coordinator as soon as possible.
(6) Notify your research coordinator of any illnesses or injury that occurred during the clinical trial - particularly if it required a clinician office visit or hospitalization. This is regardless of whether or not the illness, condition, or injury had anything to do with the study.
(7) If you are receiving study drug, then always bring study medications and empty bottles and/or boxes with you at each visit.
(8) It is our standard medical practice that patients fast at least 12 hours before having their blood drawn. This means no food or drink (although water and medications are okay). However, if you have not yet signed an informed consent document, then we cannot require you to fast before your visit, because fasting is a procedure. Fasting before you arrive is your choice.
(9) You are entitled to discontinue the study at any time of your choosing. However, considerable effort is involved in entering volunteers into clinical trials. Furthermore, each study volunteer dropped from a clinical trial decreases the overall quality of the study. Therefore, if you feel you may not have the commitment of time or effort to adhere to study procedures throughout the duration of the study, then please notify the research coordinator before you agree to participate. You should certainly do so before you sign an informed consent document.
(10) At the end of each study, it is necessary to schedule an exit visit. Therefore, even if you drop from the study early, you will be asked to keep the exit visit so that we can monitor safety issues.
If you want to participate in a clinical trial, then how do you contact us?
If you have an interest in participating in one of our clinical trials, then contact us via phone or email.