For an example of an outstanding PTN site, look no further than Ann & Robert H. Lurie Children’s Hospital of Chicago. The top enrolling site for the POPS study, Lurie Children’s has enrolled 244 patients as of September 22. To put this number into perspective, the second highest enrolling POPS site has recruited 117 patients, and the third highest 99 patients. Lurie Children’s is also a leader in the clindamycin trial, enrolling almost one third of the patients needed to complete the study. A nimble team of 6 individuals makes it all happen, under the direction of Dr. Ram Yogev, site PI and professor in Pediatrics–Infectious Diseases at Northwestern University Feinberg School of Medicine.
Dr. Yogev attributes his site’s success to communication and dedication. Site team members participate in a mandatory weekly meeting to review study progress over the preceding week and to identify and troubleshoot any problems that may have arisen. This combination of accountability and collaboration helps to ensure that everyone keeps invested in the team’s success.
But, Dr. Yogev is careful to note, communication must extend beyond the confines of the site team to ensure optimal conduct of a study. To this end, he devotes a great deal of time nurturing relationships in other departments at his institution to facilitate understanding of study goals and to bank good will with people who can help make reaching those goals possible. Dr. Yogev observes, “You can’t rely on the hierarchy to make things happen; it’s personal relationships that create a willingness to help.”
For example, one study of a drug with a very short half-life required sampling at 3 time points within a half hour. To ensure coverage for those draws, non-study personnel in relevant departments had to be enlisted and reminded to alert the site team of when eligible patients would be available. Such teamwork would be difficult to foster had those individuals not been approached and befriended by Dr. Yogev. “Thanks to this study, I have more friends than I had before,” he jests.
Much of what drives Dr. Yogev to go the extra mile in this regard is the desire to be an example to his team. “If your people see that you are dedicated,” he observes, “they will try to match or even beat that dedication.” In fact, he admits that he is in friendly competition with his study coordinator, Laura Fearn, to be the best at what they do (and she usually wins, he notes). Other team members who routinely go above and beyond include Jannie Stewart (site phlebotomist), Kathy Rosa (regulatory specialist), and Mayra Gomez (data entry coordinator).
When asked about why he decided to become involved with the Pediatric Trial Network, Dr. Yogev highlights the critical lack of knowledge to inform dosing of the vast majority of drugs used in kids. Collaboration between government, academia, and industry, he notes, is a positive way to make crucial changes — “I only wish I had come up with the idea myself!”