Agenda


Day One: Monday, March 1, 2021

12:00 - 12:15 EST Welcome and Hot Topics

Lisa Benson, BS, CRCP, Senior Vice President, Research Operations, Quality & Education, Institute for Advanced Clinical Trials for Children (I-ACT) & Amanda Galster, MPH, CCRP, Clinical Research Program Director, University of Minnesota

Ms. Benson and Ms. Galster will provide an introduction and overview of the conference. 

12:15 - 1:15 EST Pediatric Research

Octavio Ramilo, MD, Chief, Division of Infectious Diseases, Nationwide Children's Hospital; Henry G. Cramblett Chair in Medicine & Professor of Pediatrics, The Ohio State University College of Medicine

Now that we are one year into the COVID-19 global pandemic, Dr. Ramilo will present on the current state of SARS-CoV-2 in pediatrics. He will explain how this virus is different from others, what we know about COVID-19 in children, and what research needs to be done.

1:15 - 1:30 EST Break

1:30 - 2:30 EST Development of Pediatric Research Studies 

Mark Krailo, PhD, Professor Preventive Medicine, University of Southern California 

Dr. Krailo will discuss methods for identifying outcome measures in pediatric research studies. Dr. Krailo will also explain the importance of recognizing quality of life issues and of dealing with the challenges of long term participant follow up.

2:30 - 3:30 EST Compliance and Accountability: A ‘How To’ Guide for the Pediatric Population
Julie Duke Endsley, PharmD, CCRP, Medical Science Liaison, Neuro-Rare Disease, Genentech 

Dr. Duke Endsley will cover topics related to investigational product, research pharmacies, and pediatric considerations as related to study drugs. The topics will be tailored for both pharmacists and research coordinators that do not have a research pharmacy involved in their operations. Some specific topics that will be covered include compliance monitoring with calculation examples, accountability basics that will result in positive FDA audits, and teaching administration techniques to the pediatric population.

3:30 - 4:30 EST Breakout Session #1 (Day 1) - Research Operations during a Global Pandemic
Clinical research operations were dramatically impacted during the past year due to the COVID-19 global pandemic. This breakout session will allow participants to share their experiences and ideas for innovations this past year could shape our research operations moving forward.


Day Two: Tuesday, March 2, 2021

12:00 - 12:05 EST Welcome and Review of Day 1 

Amanda Galster, MPH, CCRP, Clinical Research Program Director, University of Minnesota

12:05 - 1:20 - Impact of COVID
Luke Gelinas, PhD, IRB Chairperson, Advarra

1:20 - 2:20 EST Regulatory and Ethical Considerations in Pediatric Research
Amanda Galster, MPH, CCRP, Clinical Research Program Director, University of Minnesota
Ms. Galster will review the the regulatory considerations and the ethical principles in the context of how we conduct pediatric research. She will review in detail the regulatory requirements of Subpart D, the impact on the consent process, and discuss therapeutic misconception.

2:20 - 2:35 EST Break

2:35 - 3:35 EST Obtaining Informed Assent in the Pediatric Population 
Kandice Roush, RN, BSN,  CCRP, Clinical Research Nurse, Nationwide Children's Hospital

Ms. Roush will discuss the informed assent process in the pediatric population; techniques for assessing developmental age to gauge assent requirements; helpful tips for explaining complicated medical terms and procedures in language kids and their families can understand and ways to manage updates and protocol changes.

3:35 - 4:30 EST Breakout Session#2 (Day 2) - Parental Permission & Child Assent
Obtaining informed consent for pediatric research can be nuanced and challenging. This breakout session will allow participants to practice difficult scenarios, brainstorm solutions, and share ideas.


Day Three: Wednesday, March 3, 2021

12:00 - 12:05 EST Welcome and Review of Day 2 

Amanda Galster, MPH, CCRP, Clinical Research Program Director, University of Minnesota

12:05 - 1:20 EST Kids vs. Adults in Clinical Research 
Grace Wentzel, BA, CHRC, CCRP, Director, Clinical Research Services, Nationwide Children's Hospital

Ms. Wentzel will discuss the challenges associated with conducting clinical research in the pediatric population along with operational suggestions for how to do it effectively and compliantly.

1:20 - 2:30 EST Sponsor Perspective
Roxzana Kelly, MS, Senior Clinical Study Manager, Cardiovascular/Respiratory, Novartis

Ms. Kelly will describe what sponsor companies look for when selecting sites. She will also explore challenges in study management and timelines from the Sponsors perspective.

2:30 - 2:45 EST Q&A 

2:45 - 3:00 EST Break

3:00 - 4:30 EST Budgeting and Contracting for Pediatric Trials
Lisa Benson, BS, Senior VP, Research Operations, Quality & Education, Institute for Advanced Clinical Trials for Children (I-ACT)
Ms. Benson will discuss special considerations for developing pediatric research study budgets including a review of "hidden costs". She will present best practices for contract negotiations and payment collection.


Day Four: Thursday, March 4, 2021

12:00 - 12:05 EST Welcome and Review of Day 3 

Amanda Galster, MPH, CCRP, Clinical Research Program Director, University of Minnesota

12:05 - 1:00 EST Navigating the Remote Monitoring Process during the COVID-19 PHE
Polina Eshkol, BA, CPMA, CHRC, CCRP, Manager, Clinical Research Billing Compliance, UCLA

Ms. Eshkol will provide a high level overview of the remote monitoring process (contracting, implementation, SOPs, systems), as well the possible challenges and questions that may arise.

1:00 - 2:00 EST Navigating Remote Monitoring (Sponsor Perspective),
Roxzana Kelly, MS, Senior Clinical Study Manager, Cardiovascular/Respiratory, Novartis, Javier Montalvo, Development Unit Head. Novartis, Denise Johnson Sura, Senior Director, Site Engagement, Eli Lilly and Company & William Kwan, Advisor, Site Engagement Optimization Lead, Eli Lilly and Company 

The speakers will provide a high level overview and perspective of pediatric clinical trials and the current monitoring activities given the current pandemic. Industry-based initiatives, strategies and/or recommendations that have been implemented, will be shared.  

2:00 - 2:15 EST Break

2:15 - 3:30 EST Challenges in Pediatric Research 
Janelle Allen, BS, MS, CCRP

Ms. Allen will discuss the challenges faced in recruitment, enrollment and retention of participants in pediatric trials. Specific strategies and approaches to bolster recruitment and retention will be discussed. This presentation will also include managing the transition from childhood to young adulthood by study participants.

3:30 - 4:00 EST Final Q&A

All Faculty