Before you decide to participate in a clinical research trial it's best to know what exactly a clinical research trial is, why they're conducted, what the potential benefits might be, etc.

 

What is a clinical research trial?

Medical research studies that invovle human participants are called clinical research trials. The goal of clinical trials is to determine how safe and effective a new medication or medical device is before it can be approved by the Food and Drug Administration (FDA).

 

What are the different types of clinical research trials?

There are four type of clinical trial: Phase I, Phase II, Phase III and Phase IV. Phase I trials invovle a very small number of human participants (usually 10-20 people) and seek to determine how safe a new medication is and how well it is tollerated. Phase II trials invovle a larger number of human participants (20-300) and seek to see how well a new medication works. Phase III trials invovle large numbers of human participants in many different countries and seek to determine who well a new medication works in the larger population. Finally, Phase IV trials invovle continual safety assessment of a new medication after it has been given approval.

 

Are clinical research trials safe?

Yes. It is the responsibility of the study physician, sponsor, regulatory agencies, and government agencies to carefully monitor clinical research trials to ensure patient safety.

 

Are there benefits?

Absolutely! Becoming involved in a clinical research trial allows you to become more involved in managing your illness or condition. You'll have access to new medications or treatments before they're available. You'll have the opportunity to work closely with the study physician and research staff throughout the entire process. Additionally, you'll have access to targeted medical care while participating in a clinical research trial.

 

Are there risks?

All members of the study team work hard to ensure patient safety while they are participating in a clinical research trial. However, sometimes unforseen events do happen. It's best to talk with your study doctor and trial staff about potential risks before consenting to participate in a clinical research study.

 

Where can I get more information about participating in a clinical trial?

The U.S. National Institues of Health has published an comprehensive overview of clinical research trials to help patients better understand them. To access this information, please click here.

 

I want to participate. What's the next step?

If you're interesting in participating in a clinical research trial please take a few minutes to complete the form below. Your confidentiality is extremely important to us and we will not share this information with anyone. As soon as your information is received one of our research coordinators will contact you as soon as possible.

 

If you would rather contact us directly to find our more about one of our studies, please call us at (864) 268-4500 or email us at info@southeasternresearch.com.