What are clinical studies?

Clinical studies are medical research studies in which people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration.  The research studies at Simcare Medical Research involve promising new treatments that may directly benefit patients.

Why would I want to participate in a clinical trial?

You may wish to participate in a clinical trial for a variety of reasons.

• • Researchers can’t discover new cures without your help. It can be a very   rewarding and satisfying experience as well as providing you an opportunity   to contribute to the development of new and “cutting edge” medical   treatment. You are part of a process that is essential in the development of   medications. All medications must go through this process to become FDA   approved. The studies are performed to determine how well the medication   works (efficacy) or how long it lasts (duration).
• • People who volunteer for phase II and phase III trials can gain access to   promising drugs long before these compounds are approved for the   marketplace.
• • Study participants will usually receive close and comprehensive medical   attention from highly skilled professionals who are readily available to answer   any questions you have or if you experience any side effects. Many times   you will receive diagnostic testing, examinations and treatment without   charge, depending on the study. This can help offset expenses that   otherwise would make it difficult for you to receive without insurance   coverage.
• • Compensation for your time and travel is also provided.
  

Have these medications been tested before?

Many of our clinical trials are Phase II thru IV. This means that these medications have gone through early human testing. Some of the clinical trials we conduct are for medications that have already been approved by the FDA. You will be informed of the background of any investigational product before you enroll in a new study. There is also the chance that you may be assigned a placebo (tablet or treatment with no active medication or device). How likely you are to receive a placebo or the investigational product will also be explained to you.

How long are the studies?

Each study has different requirements. Some of our studies are long term studies which can last several months or even years. Others are very short, ranging from 2 weeks to 14 weeks.

What if I want to stop participating in the study?

Your participation is voluntary and you may choose not to participate at any time. There will be no penalty or loss of benefits to which you are otherwise entitled.

Are my rights as a person/volunteer protected?

YES. Aside from knowing that a study cannot begin without governmental approval, an independent group of professionals called an Institutional Review Board (IRB) also must approve the study before it can be initiated by the study physician. An IRB is a group of medical and non-medical professionals whose primary responsibility is to review the study to make sure it poses no undue risks to the study participants. Your physician is also required to provide the IRB with periodic reports while the study is being conducted. Additionally, your medical records are held in the strictest confidence. It is also important to know that you may terminate your participation at any time without jeopardizing your access to other medical treatments.

What is informed consent?

Before entering a clinical study, it is important that you as the patient fully understand the study and what your involvement would mean. Our staff members will help by providing you with an informed consent statement, which has detailed information about the study, including the length of the study, the number of visits required, and medical procedures and medications included. It also provides expected outcomes, potential benefits, and possible risks.
We will review the informed consent statement with you and answer your questions. If you decide to participate after reviewing the statement and talking with staff and family members, you will need to sign the informed consent statement. Your signature indicates that you understand the study and agree to participate voluntarily. The informed consent tells patients that they have a right to leave the study at any time.

How do I know if I’m eligible to participate in a clinical trial?

Every study has a different purpose and specific scientific questions it is trying to answer. In order to do that, very specific criteria, or requirements, are developed to evaluate an individual’s ability to participate. After agreeing to be assessed for participation, you will undergo a very detailed screening process at no cost to you, to determine your eligibility to participate in a study.  Please click here and submit your contact information.  A staff member will contact you soon to follow-up.