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EXERCISE

Consider Participating in a Clinical Research Trial

BY JAMES E. CAIN III, MD, PI AT FMC SCIENCE

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WHAT IS CLINICAL RESEARCH?

Research is part of the scientific process where we collect data from people to be studied in order to better understand health and disease. Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease. Types of clinical research include clinical trials, which test new treatments for a disease, and natural history studies, which collect health information to understand how a disease develops and progresses over time. WHO CAN PARTICIPATE IN A CLINICAL RESEARCH TRIAL?

To participate in a clinical trial, participants must meet certain standards, called “inclusion criteria.” There are also factors that can exclude some people from participating, called “exclusion criteria.” Inclusion and exclusion criteria are often related to: • Age • Gender • Type and stage of a disease • Previous or current medications • Existing medical conditions • Recent participation in a clinical trial

Keep in mind that some clinical trials are looking for participants who have the medical condition being studied, while other clinical trials are looking for healthy study participants.

In order to become a clinical trial participant, you must qualify by satisfying both the inclusion and exclusion criteria. Inclusion and exclusion criteria are used to protect your safety during a clinical trial. WHAT ARE THE BENEFITS TO PARTICIPATION?

The health of millions has been improved because of advances in science and technology and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects is crucial to improving the health of future generations. Without your help, the research studies at FMC Science cannot be accomplished. Here are just a few of the benefits: • New and Better Treatment • Receive Expert Care • Possible Compensation • Advance Medicine Into The

Future • Convenient Location • Confidential ARE THERE ANY RISKS INVOLVED?

Every new treatment has to start somewhere. All medications that are currently available in the United States have gone through clinical research trials to determine if they are safe and effective. When starting a new treatment whether it is something that you are prescribed or receiving as part of a clinical research trial, you are always put at risk for potential side effects. When participating in a clinical trial, you are notified about the side effects that have already been observed in prior participants. You will have the opportunity to discuss these side effects and study details with the research team before you make a decision to participate. IS THERE ANY COST TO ME TO PARTICIPATE IN A CLINICAL TRIAL?

There is no cost to you or your insurance for participation. In most cases you are compensated for participating in a clinical trial. Compensation varies by each study. SHOULD I PARTICIPATE?

Clinical trials help us advance the future of medicine. Participation is critical in helping prevent, diagnose, and cure diseases and illnesses. When you participate in a clinical trial, you are contributing to research that could bring new treatments one step closer to reaching patients across the nation. Participating in a clinical trial can only be your decision. If you are unsure, you can ask your primary care physician if a clinical research trial is right for you. You can also reach out to FMC Science, and we will be glad to discuss risks and benefits in detail to help you make your decision.

FMC Science in Lampasas is committed to conducting quality, safe clinical research trials to our community. If you are interested in a research study and would like to see what we have available or to see if you qualify, contact our office at 512-556-4130. You can also visit us online at fmcscience.com.

James E. Cain III, MD, PI

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