Overview

There are many reasons why people volunteer to participate in clinical trials, including:

• Opportunity to help people suffering from medical conditions

• Access to investigation treatments before they become widely available

• Opportunity to play a role in the discovery of treatments, cures, and prevention for certain diseases or medical conditions

• Ability to play a more active role in your own healthcare

• Access to free physical examinations and diagnostic tests related to the clinical study

• Potential compensation for time and travel related to the clinical study

What is a clinical research trial?

A clinical research trial is a scientific investigation (trial or study) of a research medication or treatment to find out how it works in people. Through clinical trials, doctors help find possible new ways to prevent, detect, diagnose, control and treat illnesses. Before a new medication can be approved for use by the public, it must be tested thoroughly according to strict guidelines established by the U.S. Food and Drug Administration (FDA). Participation in clinical trials is completely voluntary and all information provided by a participant is kept strictly confidential and used only for the purposes of conducting the study as required by law.

What happens during a clinical trial?

Participation in a clinical trial means you will work with a research team in a clinical office setting. Team members include doctors, nurses, study coordinators, and other health care professionals. As a qualified volunteer for a study you will receive all medical visits related to the study at no cost. This can include: physical exams, doctor visits, study medications, laboratory tests, ECG's, etc.

What are the benefits of participating in a clinical trial?

Most of our current information on medicines and diseases has been obtained from research. New drugs are being developed daily and may offer advantages over existing ones. Still, being involved in a research study sometimes makes us uneasy. It helps if we remember the many research successes over the past few decades. For example, vaccines and antibiotics have been developed to eradicate many previously common and deadly diseases such as smallpox, polio, diphtheria, tetanus, and childhood leukemia. Some of the many benefits of participating include:

• Study-related care provided by qualified physicians.

• Learning more about your illness and the latest available treatments.

• Receiving study visits and study medication at no cost.

• Gain access to new drugs and interventions prior to public availability.

• Provide a valuable contribution to the healthcare industry.

• Could be contributing to important research that may help you, your grandchildren and future generations.

How am I protected during the research clinical trial?

Patient safety is the number one priority of the FDA, the pharmaceutical companies, and Southeast Clinical Research Center. Before participating in a study, you must agree to and sign an Informed Consent, which gives detailed information about the study, procedures, and medications including the risks. Experienced physicians who have been thoroughly trained and designated as Principal Investigator monitor you throughout the study. As with any medication, there may be unknown risks from participating in the study. An Institutional Review Board (IRB) must review and approve all studies before you are asked to participate in the study. The IRB is made up of scientific and non-scientific members, clergy, administrators, and members of the public. IRB approval of all research is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials.

Remember that participating in a clinical trial is completely voluntary and you can leave the study at any time if you change your mind.

Who participates in clinical research and how are they selected?

Lots of different people participate in clinical research. Every study identifies some specific characteristics that the participants should have in order to participate. These characteristics are called eligibility criteria. Some of these characteristics are things like age, general health, a diagnosis of a particular disease, certain symptoms, etc.

 Why can't I know which drug I am on?

A key element in any research trials is to have accurate results. The study may either compare a research drug to standard therapy or a placebo (an inactive substance). The study coordinator, physician and you may have no idea whether you are receiving the actual drug or a placebo. This ensures that the study trial has been unbiased in the results and will show how the new medication does or does not work.

 Want to Learn More?

Please contact Southeast Clinical Research to learn about our exciting research trial opportunities.

To participate in one of our clinical research studies, simply fill out the information request form and we will call you. A friendly, knowledgeable staff member will provide you with more information about the trial you are interested in, including a review of the study procedures.