A clinical trial is a research study designed to evaluate new treatments in order to determine if they are safe and effective. The FDA requires that all drugs be tested extensively prior to being approved. Clinical trials are usually sponsored by a pharmaceutical company, biotechnology company, or a health-related agency. Every time you have a headache and take an aspirin or a take an antacid for a stomach ache you are benefiting from clinical trials. These drugs went through the research process before they were available to you and me.
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 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.
Clinical trials provide participants with access to thorough diagnostic work-ups and cutting-edge treatments before they become widely available. Clinical trials are the foundation for the new medicines of tomorrow. In addition, most clinical trials also provide a physical exam by an experienced physician and extensive laboratory tests all at no cost. It is an affordable way to gain access to first-rate healthcare while making a positive contribution to medical science.
Each clinical trial is designed to answer specific questions; therefore, there are guidelines as to who can participate. These criteria are based on factors such as age, gender, medical conditions, and medical history. This allows researchers to target a specific population of people in order to gain the answers they seek.
No, all of the study procedures and study drug are provided to you at no cost. Most clinical trials also reimburse participants for their travel time.
Each study varies regarding the time commitment you must make. Some studies last only a few weeks whereas others can last up to several years. Once we know more about you we can give you more information about the length of the study. Typically, the first visit lasts 3-4 hours to provide you with an extensive evaluation and to thoroughly and accurately record your medical history. Follow up visits usually last under an hour and can range from weekly to monthly, depending on the requirements of that particular study.
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.
At the end of the study, we will discuss treatment options with you and execute a plan for your care. Our study doctor will try to get you established on an appropriate medication or treatment to then be followed up with by your primary care physician.