Nebraska Pediatric Clinical Trials Unit Update A lot of exciting things are going on at the NPCTU. We just completed our second year working to bring clinical trials opportunities to children in our community, as well as opportunities for healthcare providers and researchers to get involved in some exciting national projects. To date, nearly a dozen faculty are participating in clinical trials related to common and important child health issues through the NPCTU! We have also been reaching out to learn about what you need to get your own projects done. Research space is an issue at Children’s Hospital & Medical Center, and one that is now being addressed by hospital leadership and the Child Health Research Institute. If you have other specific needs for conducting your research on site at Children’s, we want to hear from you! Finally, our NPCTU team is growing, and with it so are the services that we can provide to investigators at UNMC and Children’s. Ellen Kerns, our new Data Manager, is obtaining certification to run reports in Epic so that she can help researchers complete feasibility studies and database queries from the Electronic Health Record. We are also in the process of hiring a second Research Coordinator who will provide some much-needed bandwidth to assist our investigators and allow for more growth. Finally, be on the lookout for a scientific writer in the future who will be available to help with manuscript and grant preparation and submission work for both junior and funded senior investigators. The NPCTU’s first two years have seen some excellent progress, and we look forward to building on that progress in the coming year, with your help!

– Dr. Rusty McCulloh

• Monday, October 1st NIH IPPCR Course registration opens and course begins (see next page for more details)

• Saturday, October 13th IDeA-CTR Seminar Series Kate Heelan, PhD, FACSM, UNK “A Community Approach to Pediatric Obesity Treatment: Kearney Public Schools and Building Healthy Families”

• Friday, October 19th American Academy of Pediatrics (AAP) 2019 Meeting – CHMC, Glow Auditorium

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• Thursday, November 1st Pediatric Academic Society (PAS) Call for abstracts begins through Jan.2nd

• Thursday, November 1st | 2-3 pm IDeA States Pediatric Network webinar “Research Recordkeeping: Essential Practices for Your Research Team”

• Thursday, November 8th | 3-4 pm IDeA States Pediatric Network webinar “30 Minutes with a Research Mentor: Dr. Daniel Hsia, Louisiana State University”

• November 28th & 29th VDORA1 Investigator Meeting Houston, Texas ________________________________

• Thursday, December 13th IDeA-CTR Seminar Series Mahbubul Majumder, PhD, UNO “Data Visualization”

• December 31, 2019 Duke Clinical Research Institute - POPS Study Drug of Interest Submissions due (see next page for more details)

Upcoming Events

Nebraska Pediatric Research Update Volume 1 | Issue 2 | October 2018

Vitamin D Supplementation in Children with Obesity-Related Asthma

• The first ISPN-generated study will evaluate several different dosing regimens for vitamin D supplementation in obese children in order to reach therapeutic vitamin D levels. As a secondary objective, the subject’s asthma control will be evaluated throughout the study.

• The Nebraska site PI will be Dr. Hana Niebur

• The study team will include Dr. Ashley Deschamp, Dr. Cristina Fernandez, Dr. Karla Lester, Dr. Rusty McCulloh, Carly Rupiper, APRN, Anna Oyer, RN, and Dennis Picken, RP.

• First subject expected to be enrolled in January 2019

https://ideapedtrials.uams.edu

research leading to advances in disease prevention and treatment. Together with the executive director, currently Dr. John Sparks, and the scientific director, Dr. Bill Rizzo, Lisa is responsible for facilitating the overall expansion of the pediatric research capacity at Children’s and UNMC, which includes:

As of July 2, 2018, Lisa Runco became the inaugural administrative director for the Child Health Research Institute (CHRI). CHRI was created and approved by both the Board of Regents of the University of Nebraska and the Board of Directors of Children’s Hospital and Medical Center in the summer of 2017 for the purposes of improving the health of children through innovative research leading to advances in disease prevention and treatment. Together with the executive director, currently Dr. John Sparks, and the scientific director, Dr. Bill Rizzo, Lisa is responsible for facilitating the overall expansion of the pediatric research capacity at Children’s and UNMC, which includes:

• attracting superior physician scientists, staff and trainees • attracting patients due to a more visible research enterprise which includes

unique discoveries and applications • identifying strategic areas of pediatric research focus and investment • and facilitating research collaboration across colleges, campuses and

community partners.

One of CHRI’s most significant goals is to increase it’s funding to $100M over the next 10 years. The Pediatric Research Office (PRO) now falls under the CHRI umbrella, as does the Nebraska Pediatric Clinical Trials Unit (NPCTU). Lisa is partnering with Ashley Servais, PRO manager, and Dr. Rusty McCulloh, NPCTU Director, to focus on establishing research administration protocols and create more opportunities for collaboration for investigators. Within the next month, there will be communications regarding how to become a CHRI member, along with its associated benefits, and how to apply for CHRI pilot grant awards. Lisa has a long history with UNMC, having spent over 20 years in academic department administration, followed by 3.5 years leading two clinical programs for Nebraska Medicine.

Information for the upcoming 2018-2019 course year:

• Please review the new NIH website: https://ocr.od.nih.gov/courses/ippcr.html • Registration opens on October 1, 2018 and ends on June 30, 2019. • The self-directed course also begins on October 1, 2018 and ends on June 30, 2019. • The final exam will be available on the course website starting November 15, 2018 and closing on June 30, 2019

(exact times will be posted to our website). • Participants who complete the final exam and score at least 75% will receive a certificate of completion.

For additional information on the course, please visit the IPPCR general information website at https://ocr.od.nih.gov/courses/ippcr.html or email Rebecca Hwang, the course coordinator, at IPPCR2@mail.nih.gov.

Introduction to the Principles and Practice of Clinical Research

Contact the NPCTU to obtain access to the ISPN Research Portal, which contains a variety of resources for investigators, including: • ISPN documents, including

protocols, calendars, newsletters, and more

• Protocol-specific investigator training modules

• Professional development modules for clinical researchers

• Archived webinars and courses

• ISPN events page

• ISPN network directory

• ISPN clinical trial data repository, including OpenClinica EDC

New Opportunity for Investigators!

The ISPN recently received news about an exciting opportunity available to our sites. As mentioned at left, the POPS study aims to shrink the gap between pediatric and adult dosing information available to prescribing pediatricians. There is officially a new process by which new drugs of interest (DOIs) may be proposed. While evaluations of DOI submissions won't begin until spring of 2019, we wanted to pass on the information so that colleagues may begin thinking of potential drugs of interest and gathering support for their inclusion in the study.

Visit the NPCTU website to learn

more!

Meet Our Team!

I am excited to begin serving as the data manager for the ISPCTN Nebraska Pediatric Clinical Trials Unit. I know that my education and experience will allow me to play a pivotal role in its ongoing success through the fulfillment of its various data management and analytic needs. I received my Bachelors of Science in Bioinformatics in 2014, followed quickly by a Masters of Public Health in Epidemiology with an emphasis in Global Health and Informatics. During and after the pursuit of my degrees, I accumulated extensive work experience in accessing, managing, analyzing and reporting data to support organizational and research needs. I tracked down Gateway for Cancer Research funded study results and created an auto-reporting data collection tool. I worked with researchers to identify, pull, and study data from a citywide

collaborative hospital database as part of the collaborative research unit at Cook County Health and Hospital System. As a CDC fellow, I decoded the patterns in Air Force industry and occupation codes and wrote a program that converted them to civilian job codes. Most recently, I worked as a research assistant for the Kansas Pediatric Clinical Trials Unit at Children’s Mercy Kansas City. As my time there progressed, my role evolved from that of an assistant to an analyst as I took over the management and data analysis of studies of several junior researchers working on projects ranging from the usability of a mobile decision aid to the association between living in a food desert and having been admitted to a hospital. I am now working as a Research Data Analyst and pursuing a PhD in Biomedical Informatics at the University of Nebraska Medical Center. I aim to leverage the breadth of data sources, types, and topics I have experience with to fulfill the wide-ranging data needs of this clinical trials unit and institution.

El Kerns, MPH Research Data Analyst, NPCTU

Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care

• Collaboration with Duke Clinical Research Institute

and Pediatric Trial Network (PTN), at up to 100 sites • Purpose is to obtain pharmacokinetic (PK) and

dosing information on drugs prescribed off-label to children

• Currently ~30 drugs of interest, including antibiotics, anticoagulants, antipsychotics, steroids, among others

• Includes special populations (pre-term, obese, ECMO)

• Opportunistic PK sampling when given per standard of care

Our Nebraska site PI is Dr. Rusty McCulloh • Sub-investigators: Dr. Josh Euteneuer, Dr.

Nate Goodrich, Dr. Sidharth Mahapatra, Dr. Kari Neemann, Sarah Newman, DNP, Dr. Laura Ortmann, Dr. Alicia Palmer, Amber Van Dyke, APRN

• Includes both UNMC and CHMC sites Please contact your team’s representative to ask about which drugs are currently open for enrollment, or look for DOI tables posted in your workrooms.

If you think you may have a potential subject, contact a member of our study team, or call or text (402) 253-9176. Thanks!

Please reach out to the NPCTU if you have any interest in participating in the following upcoming studies:

ACT NOW Clinical Trial • Based on results of ACT NOW Current

Experience study, an interventional protocol is in development to determine best practice for infants experiencing opioid withdrawal

• PI will be Dr. Ann Anderson Berry, with assistance from Sarah Newman, DNP, NNP

Pediatric Migraine Registry • Prospective registry funded by DCRI to

collect data on pediatric migraines • Will inform future clinical trial • PI will be Dr. Geeta Rathore

iAmHealthy • ISPN-generated study • Will use iPads and teletherapy model to

affect behavioral change in obese children • Plan to engage rural sites • Protocol in final stages of development

OTHER UPCOMING STUDIES

• Our site enrolled 23 infants with Neonatal Opioid Withdrawal Syndrome

• Other ISPCTN sites are still submitting data • Interim analyses being conducted; results

will inform interventional trial (see right)