Solutions - Center for Biomedical and Health Care Research

Partners in Progress Medicine for Our Future

Brian is 8 and always on the go. Heather is 20 and working diligently to graduate from college. Robert is 56 and goes to dialysis 3 times a week. Marie is 72 and has had bypass surgery and watches her cholesterol closely. What is it about this group of diverse individuals that makes them stand out in a crowd?

They are the quiet heroes who make up the ranks of clinical research volunteers, Partners In Progress, at Saint Louis University’s Center for Biomedical and Healthcare Research. They will never be in the news, receive the Nobel Prize for medicine, or be credited for curing any disease. Yet each of them represents an army of volunteers who contribute enormously to the advancement of medicine. Without quiet heroes like these we would not have modern day vaccines, new antibiotics to fight increasingly resistant infections, gallbladder surgery done through two tiny incisions, more effective pain medication, or cancer treatments.

Each year hundreds of new medications, devices, and procedures must undergo extensive testing to measure their effectiveness and assure their safety before being made available for public use. This testing, a 4-stage process, is conducted by pharmaceutical and biotechnology companies, the National Institute of Health, and academic institutions. According to recent FDA statistics, the average cost of bringing a drug, device, or procedure from a concept to being available for the public is about $900 million and takes seven to fourteen years. As of February 2003, the Food & Drug Administration (FDA) was evaluating about 350 drugs for treatment of more than 200 diseases.

After the medication, device, or procedure is developed, it undergoes an average of 3 years of testing in laboratory and animal models for both effectiveness and safety. The results of this testing, along with a protocol or the clinical research study plan is presented to the FDA, other regulatory agencies, and Institutional Review Boards (IRB) for evaluation. These groups are charged with protecting the safety of the public. Only once the FDA approves the results and protocol, can the drug, device, or procedure begin formal testing in humans. Research sites are chosen to carry out this plan and volunteers are invited to participate. Research sites must meet specific criteria set by the sponsor of the study. Volunteers invited to participate must also meet specific criteria as required by the protocol. For example, volunteers in a Phase 1 (new investigational product) vaccine study must be in good health and without any significant health problems. In a Phase IV study, a drug (already approved for use by FDA) being tested for a new use, volunteers may need to have a specific health problem. Such a study could be to measure the effectiveness of a medication on chronic fatigue when it was previously only used for insomnia accompanying sleep apnea. Each investigational drug, device, or procedure must safely pass through Phase 1-3 before permission is granted to proceed to this final phase of testing.

The research professional’s responsibility in this process is to monitor the volunteers’ response to treatment, protect their privacy and ensure their safety. Through observation, questionnaires, and laboratory tests they evaluate the effectiveness and safety of the investigational drug, device or procedure. These results are reviewed by monitors who assure that the rules and regulations governing human research are upheld. At anytime during a clinical research study, the sponsor, FDA, the IRB, or the research physician can stop a volunteer’s participation or the complete study if the volunteers' health and well-being is at risk.

So, how does being a volunteer tie Brian, Heather, Robert or Marie together? While Brian is an energetic 8 year old, he is frequently in the emergency room with asthma attacks. He is also a participant in a clinical research study investigating a new asthma medication that may decrease the number of asthma attacks he has. Heather is a healthy 20 year old volunteering for a vaccine study. This vaccine may someday protect an unknown number of people from a potentially lethal illness. Robert has chronic renal failure requiring him to undergo dialysis three times a week while participating in a research study about a new device to improve the dialysis process. Marie is an active grandmother who takes her study medication daily in hopes of improving her cholesterol levels and in doing so, provides valuable information that will be used in treating the cholesterol levels of people in the years to come.

Saint Louis University Center for Healthcare and Biomedical Research is continually leading new trials that contribute to the advancement of medicine. To join the forces of Partners in Progress and become a clinical research volunteer, please contact us at (314) 977-6335. The contribution of these quiet heroes is cornerstone to this effort. Without them, the medicine for our future would not be possible.

All names in this article have been changed to protect the privacy of the volunteers.