For many of us, being diagnosed with a serious life changing illness can mean starting a stage in life filled with new doctors, nurses, tests, procedures, treatment regimens and plenty of confusion. And on top of everything else, you may be asked about considering clinical research or clinical trial, clinical study or research study. That is when MediSphere comes in. Our studies are what sponsors create to find out if a potential study drug works and is safe.
Medisphere is a Phase II, Phase III, and Phase IV research facility meaning we conduct trials with pharmaceutical, biotechnological, and medical devices. Pharmaceutical trials are conducted using study drugs that have been around a while, but are being studied in different illnesses. Every drug goes through a clinical trial.
These studies answer questions like what side effects the drug has, does it stop of slow down the illness it is designed to treat? Does it work better than current treatments? Can it be given along with other drugs? These answers must come in the form of scientific data or facts, not the opinion of doctors, patients or families involved, but the actual results that are collected and monitored.
Doing a clinical study, it is important to have patients of every race and ancestry included in the studies to better understand how the drug works and every patient population. All potentially eligible patients are invited to consider a study regardless of race, ancestry, sexual orientation, gender identity or disability status. Diverse representation matters in studies to understand if results differ.
Because of the diligent monitoring, patients get personalized care from doctors and nurses, while in the clinical research studies. Some studies are comparative, meaning that some patients will get the standard treatment plus the study drug, while others will get the standard treatment plus a placebo.
Other benefits include:
Always remember, it is up to you to decide whether a study is right for you. Study participation is voluntary and requires your informed consent or permission from start to finish and, of course, volunteers have the freedom to leave any study at any time.
Not every patient is eligible for a study. Enrollment is based on meeting certain criteria for entry. If you meet all requirements and you decide to participate, your informed consent is required before any study procedures can be done.
An Informed Consent is provided to all study participants who enroll in a study. The purpose of this form is to provide details about the study, the risks associated with the study medication, and what procedures the volunteer will undergo during the course of the study.
Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors and scientists who are dedicated to making sure that the study participants are not exposed to unnecessary risks.
You may volunteer for a clinical trial by calling MediSphere at 812-471-4110 and ask what studies for which we are currently enrolling or visit our website at medisphereresearch.com.
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