CLINICAL TRIAL FAQ's
CLINICAL TRIAL FREQUENTLY ASKED QUESTIONS:
WHAT IS A CLINICAL TRIAL?
Before a drug can be prescribed for any indication (i.e. psoriasis, HS, atopic dermatitis), it must go through a long testing and approval process for the FDA, which includes the clinical study process. A clinical study is used to test new drugs (medications) and develop new uses for existing drugs. At our research clinics, we work with some of the world’s leading companies and physicians on studies to answer questions like: Is my drug better at treating this disease than the current drugs on the market? How long does the drug continue to be effective after the prescribed course is completed? How long does a drug remain in your body (which is called the half-life)? Do I have to continue to take this drug or can it be stopped once I reach my desired results?
WHERE CAN I FIND OUT MORE INFORMATION ABOUT PARTICIPATING IN CLINICAL STUDIES? All studies are listed on clinicaltrials.gov but you can call our office if you are interested in participating in clinical studies that we offer at our office. Just call 270-873-2274
WHAT ARE THE RISKS AND BENEFITS OF TAKING PART IN A CLINICAL TRIAL? If you are interested in participating in a specific study any and all potential risks and side effects will be explained to you in detail before you give your consent to participate. All previous side effects are explained and outlined. The benefits will also be detailed to you as well. You will also be able to discuss any concerns you may have with a member of our medical team at any time. (Most participants in clinical trials are satisfied with the outcomes and happy they participated while allowing the documentation to be collected to help others with their disease state).
HAVE ALL MEDICATIONS GONE THROUGH THE CLINICAL TRIAL PROCESS? Yes, there is not a medication approved by the FDA that has not gone through this process before. Any medications you are currently taking for your disease state or any disease, has previously been tested in clinical trials and was not approved without showing the benefit of the drug. Also no auto injector or device has been approved for use without showing that the device is just as effective as the previous syringe.
ARE THE URBAN MYTHS ABOUT CLINICAL TRAILS TRUE? There are plenty of urban myths about what happens on a clinical research study. These are just that: myths. You are NOT A GUNIEA PIG. Your safety is our number one priority. Drug development is highly regulated with strict safety and ethical guidelines and we take those regulations very seriously. If a drug is not considered safe it will not make it to or through the clinical trial phases, where a larger number of patients are using it throughout each phase.
WHAT ARE MY RESPONSIBILITES AS A STUDY SUBJECT? Depending on the study, there are certain conditions we may ask you and every participant across the globe, to meet to ensure accurate study results. These may include restrictions on exercise, smoking, other medications, food, recreational drugs and alcohol. We’ll give you full details before you apply to take part in a study so you’ll always know what’s expected. We require that you comply with the protocol guidelines and come to your visits on time when scheduled, and that you complete any and all paperwork or electronic diaries given. It is the information collected at those time points from you regarding your opinion of your disease improvement or not, as well as the physician’s assessments of your disease states improvement or not during that visit. That is collected then provided to the study sponsor, as the clinical data that the pharmaceutical companies then present to the FDA. The pharmaceutical company has to take that information along with their scientific data and present it all together showing how well their drug actually works.
WILL I BE PAID AND HOW WILL I RECEIVE MY PAYMENT? Yes, and no. You’ll be given what the study calls a travel stipend for participation during the clinical study, as it is not called a payment. The stipend you receive varies from study to study, depending on its length and type. Stipend details will be discussed with you by your study team at your first visit. The amount is located in your consent form, and is not decided by the study team. The visits are free to you, the medication being studied is free to you for the duration of your study participation, and a travel stipend is paid to you, the study patient. The information is in your informed consent form and the stipend is paid to you for every completed visit. You will either receive a check from the study site or you may receive a debit card from the site that is automatically uploaded after every visit depending on the study protocol.
WHAT IF I CHANGE MY MIND? Our clinical studies are always voluntary. You are free to withdraw your consent at any time. Once you’ve already started the clinical study, our doctors may need you to come back for a visit, just to check that the drug is out of your system. We would also like to prove to you and the sponsor that you are as healthy going out of the study as you were going in. As always your continued safety is everyone’s main concern.
HOW ARE MY RIGHTS AND WELFARE PROTECTED? We only use licensed medical staff and physicians to conduct our clinical studies. An independent regulatory board reviews each study including all procedures. This review is conducted to make sure the study is scientifically and ethically sound.
This review board oversees the processes that we use for informing you about clinical research studies, including the following:
The purpose of the study
What happens during the study
Risks and benefits of study participation
Background information on the drug itself
Other studies involving the drug
WILL MY INFORMATION BE KEPT CONFIDENTIAL? Our staff respects your privacy. No information will be given out about your participation and/or your medical information without your approval unless required by law. For example, the sponsor, regulatory agencies, or an independent review board may inspect your clinical research study medical records. This may include (but not always) your name, address or other information that identifies you. If necessary, some or all of your non-identifiable records may be copied during these inspections. Because of this, absolute confidentiality cannot be guaranteed. The results of the clinical study may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications ever at any time, just the data information presented as a whole.
IF YOU HAVE ANY OTHER QUESTIONS, JUST GIVE US A CALL AND WE WILL BE HAPPY TO ANSWER THEM FOR YOU. CALL 270-873-2274