In 1996 Cheryl Patterson Leon RN, BSN was recruited to work for the University of Tennessee as the lead patient recruitment manager for The Women's Health Initiative (WHI). WHI was a long-term national health study that focused on strategies for preventing the major causes of death, disability, and frailty in older women, specifically heart disease, cancer, and osteoporotic fractures.
This multi-million dollar, 20+ year project, sponsored by the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), originally enrolled 161,808 women aged 50-79 between 1993 and 1998. The WHI was one of the most definitive, far-reaching clinical trials of post-menopausal women's health ever undertaken in the US.
In 1998 at the conclusion of UT’s study and for 10 years thereafter Cheryl became a full time mother of 3. However, in 2009 an endogastric medical device company, having invested $100M+ bringing a transoral fundoplication device to market, was having some difficulty identifying and enrolling patients into a highly selective medical device clinical trial. After 2 years, the trial, to that date, had only successfully enrolled and treated 8 patients.
This trial, if successful, could be the evidence necessary to secure support for a Level 1 CPT CODE. After a thorough review of the patient recruitment procedures, Cheryl, the company’s internal team and a robust patient recruitment marketing firm executed a plan. In 12 months 88 patients had been enrolled and treated, the study was closed and the company exceeded the study deadline by 5 months, saving $5.2M in budgeted trial costs. In 2014 the company received a Level 1 CPT CODE.