PTN Spotlight: Paula Delmore, Wesley Medical Center

Paula Delmore, left, with Dr. Barry Bloom, Wesley Medical Center Medical Director

Paula Delmore has actively participated in the support of clinical research for the past 30 years. Although the majority of her expertise is in the role of site study coordinator, she has served in the roles of multi-site coordinator, sub-investigator, and principal investigator. Her main strengths lie in her attention to detail and solid understanding of clinical trial execution in the neonatal area. Her team routinely performs as a highest enroller, which speaks to her exemplary coordination and good communication with providers, nursing staff, and families. We sat down with Paula to learn more about her work and involvement with the Pediatrics Trial Network.

Q: How long have you worked at Wesley Medical Center and what are your primary responsibilities?

A: I have been at Wesley Medical Center for 40 years and currently work in an administrative role. I supervise nurse practitioners, physician assistants, and support personnel with the Neonatal Intensive Care Unit (NICU).

Q: How does your role as a site coordinator with PTN overlap with your responsibilities as part of the Wesley Medical Center administrative staff?

A: I’ve been working with our Medical Director, Dr. Barry Bloom, for 35 years as a research coordinator. Over time, my role has advanced from being a research assistant to coordinating studies, and at times, being the principal investigator. I have been the principal investigator for a couple of PTN studies, most recently the PTN Baby TAPE study.

Q: How long has Wesley Medical Center been part of PTN?

A: From the very beginning! We were one of the first centers in the Rapid Start Network. We participated in the Fluconazole Safety study and all the early Pharmacokinetic (PK) Antibiotic studies.

Q: What have you found to be the most rewarding aspect of PTN?

A: PTN covers the gamut of pediatrics, but what I find most rewarding and exciting is that they continue to explore new therapies for neonates, and also validate standard practice where there is no prior evidence.

Q: Is there an experience you’ve had with PTN that has been particularly impactful?

A: Right now we are participating in the Sildenafil II study. As part of that study, it’s really great to work with families and offer them something that could potentially help their baby. Even though everything is an unknown, and we aren’t sure it’s going to help, it’s nice to offer parents the chance that our research and efforts will benefit their child. In general, giving families another option for excellence in care is what I find to be the most impactful.

Q: Why would you recommend other investigators become a part of PTN?

A: The responsiveness of the lead investigators is phenomenal. When questions arise, they are ready and available to answer and are very timely. This allows for the seamless continuation of patient enrollment and helps in meeting the randomization timelines. The PTN studies are some of the most organized and efficient I’ve been a part of.

NICHD renews federal contract for Pediatric Trials Network

The Pediatric Trials Network (PTN) was recently awarded a contract by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to design and lead pediatric trials over the next eight years.

“Over the last eight years, we have been able to conduct 26 clinical trials in 13 different therapeutic areas enrolling over 8,000 children, which is more than triple the scope of work that was outlined in the initial NIH contract,” said Daniel Benjamin, Jr., MD, PhD, principal investigator and chair of the PTN.

Benjamin was the original awardee of the NIH contract in 2010. He and the PTN’s program manager, Gary Furda, helped secure the second award for an additional eight years. Additional DCRI faculty supporting the contract include Christoph Hornik, MD; Kanecia Zimmerman, MD; and Michael Cohen-Wolkowiez, MD, PhD.

“Danny and his primary supporters on the faculty side are outstanding in what they do and their passion for improving the health of children is unmeasured,” said Taylor Nguyen, a senior business development associate at Duke who was part of the grant-writing group. “The incredible results that the PTN team has produced over the course of the last eight years are largely due to their commitment and passion and how they go above and beyond in the work they do.”

“In the first eight years of the PTN, we were able to transform neonatal and obesity trials,” Benjamin said. “Over the next eight, we will have people rethink the way drug studies are done for breastfeeding women and mental health for children.”

Benjamin intends for the PTN to lead the way in revolutionizing the way clinical trials are conducted in children.

“We will continue designing larger trials and make these large trials more efficient,” he said. “With all the operational excellence at the DCRI, the junior and mid-career faculty, and our very determined staff at the PTN sites working together round the clock in various capacities and doing exceptional work for the network, no goal is big enough.”

Annual STAR Program for aspiring researchers now under way

The Summer Training in Academic Research (STAR) Program welcomed 21 participants at its kickoff event today. Now in its sixth year, the program provides hands-on research experience for undergraduate students, high school students, and high school teachers during the summer academic break.

“The STAR program is an excellent way for students to learn more about clinical research and how to effectively work in a collaborative environment,” said program leader Dr. Danny Benjamin, principal investigator for the PTN and faculty associate director of the Duke Clinical Research Institute (DCRI).

During the eight-week program, participants are placed in teams and matched with faculty mentors to work on original, hypothesis-driven projects. Participants also receive intensive instruction in developing scientific manuscripts, applied statistics, and data analysis. A goal of the program is to have every trainee qualify for co-authorship on a peer-reviewed manuscript related to their team’s project.

“I joined the STAR program because I want to be a neurosurgeon one day. Spending time with the STAR program mentors will help me determine if I’m on the right path to achieving my goals,” said Millbrook High school rising senior, Kennedy Hill.

The faculty of the STAR Program is actively involved in research sponsored by the National Institutes of Health (NIH). Combined, these faculty members have more than 200 publications with trainees as either first author or co-author.

In addition to the research project, program participants attend lectures on neonatology, antimicrobial therapy, pharmacoepidemiology, and medical ethics. Eligible students experience clinical medicine firsthand by shadowing a physician on hospital rounds.

Visit the STAR Program website for more information.