New tests and treatment are not sold on the market as soon as they are created. They need to first be studied. A clinical trial, also known as a medical research trial, is a type of research that study a medication or device given to people. These trials examine how safe and helpful these medications, treatments, or devices are. If found to be safe and helpful, they may be possibly be sold on the market and may become tomorrow’s standard of care.
Medical Research trials can study many things, such as:
New drugs not yet approved by the U.S. FDA (Food and Drug Administration)
New uses of drugs already approved by the FDA
New ways to give drugs, such as in pill form
Use of alternative medicines, such as herbs and vitamins
New tests to find and track disease
Drugs or procedures that relieve symptoms
New medical devices
What occurs during a screening visit?
If you are scheduled to come to our clinic for a medical research study. We would first like to say thank you!
The screening visit is the first initial visit when participating in a clinical research trial. At the beginning of your visit, you will be given time to read the Informed Consent Form. The clinician will then review and discuss it with you. The bulk of your visit will be taken up by this discussion. Please do not sign the Informed Consent Form until your questions have been addressed and you have decided that the study is a good fit for you. You are also welcome to take the consent document home and discuss the content with your family, friends and doctor for additional input on your participation in the study.
If you decide that participation in our research study is right for you, you will be asked to sign the consent form. A copy will be provided to you for your reference. Once you have completed this initial process, you are still welcome to ask questions and review the information with your friends, family and doctor all throughout your participation in the study.
Our clinician will complete your Medical History form with you and clarify any information that may be relevant to your current state of health. Depending on the study, our clinician may perform a physical examination and our medical assistant may possibly draw your blood and perform any other necessary procedures. You may be asked questions about your current health and medical history.
Typically, you are reimbursed for your time and travel for this visit. You can discuss compensation with our site staff during the information and consent discussion.
What is an informed consent?
The Informed Consent Form is one of the most important documents that you will sign to participate in a clinical research study. It is the document that provides many of the details about the study, including the schedule of visits, participant risks and compensation information. Our site staff and the study doctor will review this with you. As stated in previous question this will take the most time during your first visit at our site.
Why do some people make the decision to participate in a clinical research study?
Access to new medications or procedures before they are widely available The most common reason people volunteer to participate in medical research studies is access to new medications or procedures before they are widely available. Research participants oftentimes struggle to afford expensive medications even if they have insurance. In clinical trials, volunteers may have access to new and innovative medicines and treatments. Study medications are provided to research volunteers at no cost.
No Insurance Needed to Receive Care
Many people suffer terribly due to lack of medical insurance to help cover the costs of diagnosis and treatment of their condition. In a clinical trial, insurance is NOT required to participate. In fact, in most clinical trials study volunteers are compensated for their time and participation while in the study.
Contributions to the Well Being of Society
Many people volunteer for participation in medical research studies because of their contribution to the wellbeing of society, and the advancement of medical research. When study volunteers participate in research, society benefits, bringing new hope for patients afflicted with different conditions/diseases. Future generations, potentially even the volunteers’ children or grandchildren, may benefit from the volunteers’ choice to further medical research. Additional knowledge is also gained about the way the human body functions and processes medications, as well as how our bodies can heal more efficiently.
Participation in a clinical trial gives you the opportunity to develop a close doctor-patient relationship in which you could receive trial medication and treatment for the duration of the trial absolutely free of cost. Some trials may also provide monetary compensation for your time and effort involved with the trial. This can be especially helpful to those individuals on a fixed budget, those without access to health insurance, and those on high deductible health plans.
What are the trials you currently have?
For more information about our current trials, please visit our current trials here.
Does my participation take place of my primary health visits?
No. It is extremely important to ensure that you continue to see your primary health care physician for your standard of care treatments. Furthermore, most clinical trials provide short-term treatments related to a specific illness or condition, they do not provide extended or comprehensive primary health care after your trial has ended. It is also important that your primary health care provider is aware of your participation in a trial so that they can ensure that any new prescriptions or diagnoses do not conflict with the medical trial guidelines.
Will I get Paid?
There are several valuable benefits of participating in a clinical trial. There is potential for treatment or medication for your health condition and the personal one-on-one medical care, both of which you would receive absolutely free of charge and with no involvement of your health insurance. Depending on the length of your trial, these benefits can add up to thousands of dollars. You also have the benefit of feeling good about participating in research that could benefit future generations.
In addition to free medication, many of our clinical trials also offer monetary stipends for each clinic visit completed during the course of your trial. Some trials also include reimbursement for mileage if you live out of town. If you qualify to participate in one of our clinical trials, you will receive detailed information from a study coordinator about the available stipends, number of visits required, and the overall trial schedule.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to Invocare Medical Research & Healthcare Center clinical trials. Our medical research trials are federally regulated with built in safeguards to protect the participants. The medical research trials follow 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 any of these reports.
Can I leave a medical research study after I started?
Yes. You can leave a medical research study at any time during the duration of a study. Our medical trials are strictly voluntary, so if you change your mind you are free to withdraw your consent. If you’ve already started on study medication or treatment, we want you to come back for a final check-up visit and to share your reason for leaving the trial.