Solutions - Center for Biomedical and Health Care Research

About Clinical Trials

What is a clinical trial?

A clinical trial is a research study designed to answer specific questions about experimental drugs, vaccines, or new ways of using current treatments. Research studies are used to determine if the experimental drug or treatment is safe, effective, has a benefit, and if there are risks or adverse reactions associated with its use.

Why are clinical research studies necessary?

For society to have access to new medications and therapies, research studies must be conducted in accordance with the guidelines set forth by the Food and Drug Administration (FDA). Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Who pays for clinical research studies?

There are two usual sources for funding of clinical research studies: 1) the federal government (through the National Institutes of Health), and; 2) private industry (pharmaceutical & biotech companies). The sponsor of the clinical study contracts with physicians to conduct research studies. Physicians are typically paid on a per-patient basis and the medical care is often provided free to the study participant. Study participants are often compensated for their time and/or travel expenses incurred as a result of their participation in a clinical study.

Why should a person volunteer to be a study participant?

Every new drug (or device) must undergo testing prior to FDA approval for its commercial use. Volunteers in research studies can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help society by contributing to medical research data. Study participants are needed in all age groups, ethnic groups, and all socioeconomic backgrounds. Study participants are the cornerstone of the research process and progress. Any person considering participation in a research study should discuss it with their primary health care provider. They should investigate the credentials and experience of the individuals and the facility involved in conducting the study.

What safeguards are in place to ensure that research studies are ethical and rights of study participants are protected?

There are two important ways that a study participant's rights and safety are protected. First, any research study must be reviewed and approved by an Institutional Review Board (IRB). The IRB, composed of physicians and lay people, is responsible for examining the study's protocol to ensure that the study participant's rights are protected, and that the study does not present unnecessary risks to participants. Second, anyone participating in a clinical study in the United States is required to sign an "informed consent" form detailing the key facts of the study. This form identifies the nature of the study, the risks involved, what may happen to the participant during the course of the study, and will tell the participants that they have a right to leave the study at any time for any reason.

SoLUtions is required by Saint Louis University to use the Saint Louis University Institutional Review Board. Any volunteer with questions about their rights as a research subject may contact the Chairperson of the Saint Louis University Institutional Review Board at (314) 977-7744.

How can a person participate in a research study?

If you are interested in participating in a research study, would like to know what studies are currently available, or would like further information about SoLUtions, you may contact SoLUtions staff at (866) SLU-WELL (toll free) or (314) 977-6335 or email solutions@slu.edu. SoLUtions staff will be glad to send you information about our clinical trials and follow-up with you to answer any questions.

You may also visit SoLUtions Current clinical trials or Upcoming clinical trials for further information.

What happens once a person decides to participate in a clinical trial?

 

Once a person agrees to participate in a clinical trial, SoLUtions staff will follow these steps:
1. Informed Consent - During an initial consultation SoLUtions staff will informed a study participant about the study in detail and will answer any questions to assure that the study participant understands everything involved in the research study. The study participant will also read and sign (should he/she agrees to participate) an informed consent document for the research study.
2. Eligibility Screening - The study participant will complete a health questionnaire and will receive a medical exam that may include blood/urine tests and a physical exam.
3. Treatment assignment - If the study participant qualifies for the study, he/she will be given the experimental drug and instructions on how to take the drug. The participant will be asked to keep record of any physical reactions he/she may have to the drug and to return to the clinic for follow-up study visits.
4. Monitoring - SoLUtions staff will monitor the effects of the drug by testing the study participant's blood or performing other examinations (i.e. EKGs, x-rays, physical exams, etc.) during follow-up visits at various times throughout the study period.

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