Florence Rotary welcomed Pamela Miefert of MCM Clinical Research to the January 30th meeting at the Airport Hilton. MCM provides staff and facilities to enable local clinicians to perform clinical research in Northern Kentucky. Ms. Miefert is the Director of Clinical Operations for MCM. She highlighted the fact that the MCM research staff provides over 50 years of combined clinical research experience.
MCM’s primary study areas include Adult ADHD, Diabetes, Alzheimer’s disease, Obesity, Substance Abuse, COPD and Hepatitis among others. The Clinical Trials conducted by MCM are used to determine whether new drugs or treatments are safe and effective in humans. MCM works closely with physicians, patients and pharmaceutical companies to ensure that the trials are carried out in a safe and effective manner. Results are carefully documented and reported to the study sponsors, in strict adherence to FDA guidelines for testing and reporting.
Ms. Miefert explained the various Phases of Clinical Trials. During Phase 1 a new drug is given to a small group of healthy individuals to establish safety and tolerance. Phase 1 trials are conducted in a clinical setting, typically involve overnight stays and close monitoring of the individual subjects. MCM then participates in Phases II through Phase IV of the testing process. In Phase II, a drug is given to a larger group, between 200 to 500 patients with a disease condition to determine a range of doses, drug safety and effectiveness. In Phase III the drug is given to a larger group – 1,000 to 3,000 patients to establish the drug efficacy and effectiveness in selected doses. Phase IV studies continue after a drug has been approved to monitor safety in larger populations. Phase IV studies may also include studies of an already approved drug for new indications or dosages.
Ms. Miefert identified several benefits for patients participating in drug trials. She noted that participants may be among the first to benefit from a new drug if it proves effective. Participants may also receive a more consistent level of health care during the trial period by a selected research team. In most cases participants also receive compensation for their time and travel. Naturally, participants in drug trials may also be the first to encounter side effects from the drug under study. She noted that Viagra was originally under study as a drug to control hypertension – the now well-known side effects were unexpected at the time.
MCM Clinical Research is located in Suite 300 in Medical Office Building 1B adjacent to St. Elizabeth Medical Center in Florence, Kentucky. The company was established in 2007, a member of the Better Business Bureau and a member of the Northern Kentucky Chamber of Commerce since 2008.
For information about the weekly meetings, guest speakers, and community service opportunities of the Florence Rotary Club, contact Pat Moynahan, president at amoynahan@insightbb.com or 859-802-0242. Visit the group’s website at www.florencerotary.org. Florence Rotary meets weekly on Mondays at noon at the Airport Hilton Hotel in Florence.
