Event Calendar

Agenda

Pediatric Clinical Trials Conference

2020 Agenda

For a printable PDF agenda, click here.

DAY ONE

8:00 – 8:30 - Registration and Continental Breakfast (provided)

8:30 – 9:00 - Introduction to Pediatric Clinical Research
Susan Devine, Research Consultant
 

Ms Devine will provide an introduction and overview to the Pediatric Research Conference. During this time there will be discussion to assist the faculty in getting to know our attendees and their learning objectives.

9:00 – 10:00 - Opening Plenary Session
Ronald Portman, MD, FAAP, FASN, Executive Director, Pediatric Development, Science and Innovation, Novartis Pharmaceutical Company

10:00 – 10:15 - Break and opportunity for discussion

10:15 – 11:15 - Regulatory and Ethical Considerations in Pediatric Research
Amanda Galster, MPH, CCRP, Director, Clinical Research Program, University of Minnesota Department of Pediatrics
 

Ms. Galster will review the regulatory considerations and ethical principles in the context of pediatric research. She will review regulatory requirements, the consent process and discuss therapeutic misconceptions.

11:15 – 12:15 - Project Planning and Management
Susan Devine, Research Consultant

Ms. Devine will discuss project planning and management of pediatric research trials based on a project management approach. Helpful templates geared to enhance efficiency will be shared.

12:15 – 1:00 - Lunch (Provided)

1:00 – 2:00 - Monitoring, Auditing and Compliance
Lisa Benson, BS, CRCP, Senior Vice President, Clinical Research Operations, Quality and Education, Institute for Advanced Clinical Trials for Children

This session will consider monitoring and auditing issues specific to pediatric research. Ms. Benson will highlight FDA inspections and financial compliance. The concept of minimizing risk through good clinical practice will also be explored.

2:00 – 3:00 - Round Table Discussions 
Susan Devine, Research Consultant
Lisa Benson, BS, CRCP, Vice President, Clinical Research Operations, Quality and Education, Institute for Advanced Clinical Trials for Children

Through a series of directed questions, participants will engage in discussion related to pediatric research in their specific research areas.

3:00 – 3:15 - Break and Opportunity for Discussion

3:15 – 4:15 - Pediatric Rare Diseases Clinical Research
Grace Wentzel, CCRP CHRC, Director, Clinical Research, Nationwide Children’s Hospital

Ms. Wentzel will discuss the administrative and financial challenges of conducting pediatric rare disease research. Additionally she will discuss these trials from the site and patient perspective.

4:15 – 4:30 - Day One Round Up / Questions and Answers All Faculty

 

DAY TWO

8:00 – 8:30 - Continental Breakfast (provided)

8:30 – 10:00 - Budgeting and Contracting for Pediatric Trials
Lisa Benson, BS, CRCP, Senior Vice President, Clinical Research Operations, Quality and Education,
Institute for Advanced Clinical Trials for Children

Ms. Benson will discuss special considerations for developing pediatric research study budgets including a review of “hidden costs”. Ms. Benson will present best practices for contract negotiation and payment collection.

10:00 – 10:15 - Break and Opportunity for Discussion

10:15 – 11:15 - Consenting in the Pediatric Population
Kandice Roush, RN, BSN, CCRC, Clinical Team Leader, Clinical Research Services, Nationwide Children`s Hospital

Ms. Roush will discuss the informed consent 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 children and their families can understand. Ms. Roush will also discuss ways to manage updates and protocol changes.

11:15 – 12:15 - Sponsor Perspective
Roxzana Kelly, MS, Clinical Trial Head, 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.

12:15 – 1:00 - Lunch (Provided)

1:00 – 2:00 - Trials and Tribulations of Device Research
Michael Mapel, CCRP, Pediatrics Clinical Research Lead, UCLA

Mr. Mapel will discuss conducting pediatric device research essential to advancing the field and ensuring state-of-the-art care for patients. He will describe the distinct rules and regulations for device research which are necessary to successfully conduct these studies.

2:00 – 2:15 - Break and Opportunity for Discussion

2:15 – 4:15 - Challenges in Pediatric Research
Janelle Allen, MS, BS, CCRP, Director, Clinical Research Operations, Quality & Education, Institute for Advanced Clinical Trials for Children

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.

4:15 – 4:30 - Close Group Discussion/ Q & A Day 2 Sessions

Day oNE
8:00-8:30     Registration and Continental Breakfast (provided)
8:30-9:00     Introduction to Pediatric Clinical Research
Susan Devine, CCRP, Research Consultant
Ms Devine  will provide an introduction and overview to the Pediatric Research Conference.  During this time there will be discussion to assist the faculty in getting to know our attendees and their learning objectives.
9:00-10:00     The Impact of the FDARA 2017 on Drug Development for Children with Cancer- Orphans No More
Gregory H. Reaman, M.D., Associate Director, Oncology Sciences, Office of Hematology and Oncology Products, OND, CDER, Associate Director for Pediatric Oncology, Oncology Center of Excellence, OC, FDA
Dr. Reaman will discuss the impact of the FDARA 2017 on drug development for children with cancer and its impact of clinical pediatric clinical research.
10:00-10:15   Break
10:15-11:15     Regulatory and Ethical Considerations in Pediatric Research    
Amanda Galster,  MPH, CCRP, Director Clinical Research Program,  University of Minnesota Department of Pediatrics
Ms Galster will review the regulatory considerations and ethical principles in the context of pediatric research.  She will review regulatory requirements, the consent process and discuss therapeutic misconception.   
11:15–12:00  IND/IDE Submissions -  When to apply for an IND, What are the regulatory requirements?
Emily Owens Pickle, BS, CCRP, Pediatric Neuro-oncology Coordinator, Orlando Health, Arnold Palmer Hospital for Children
Ms Owens Pickle will provide an overview of when an IND or IDE application is required, expanded access regulations and examples we encounter in pediatrics.  
12:00-12:45     Lunch (provided)
12:45-1:45     Development of Pediatric Research Studies
Mark Krailo, PhD Professor, Department of Preventive Medicine, University of Southern California, Keck School of Medicine
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.
1:45 – 2:45    Round Table Discussions
Susan Devine, CCRP, Research Consultant
Lisa Benson, BS, CCRP, CRCP, Vice President Clinical Research Operations, Quality and Education Institute for Advanced Clinical Trials for Children
Through a series of directed questions, participants will engage in discussion related to pediatric research in their specific research areas.
2:45 -3:00    Break and Opportunity for Discussion
3:00- 4:00     Monitoring, Auditing and Compliance
Lisa Benson, BS, CCRP, CRCP, Vice President Clinical Research Operations, Quality and Education Institute for Advanced Clinical Trials for Children
This session will consider monitoring and auditing issues specific to pediatric research. Ms Benson will review techniques for audit preparation and the importance of self-monitoring. The concept of minimizing risk through good clinical practice will be explored as well. A discussion on financial compliance will follow.   





(Day 1 Continuted)
4:00 – 4:30     Global Pediatric Clinical Trials Network
Lisa Benson, BS, CCRP, CRCP, Vice President Clinical Research Operations, Quality and Education Institute for Advanced Clinical Trials for Children

Ms Benson will provide background to the Global Pediatric Clinical Trials Network including its goals and issues it is working to solve. The presentation will also discuss the programs key stakeholders.

4:30 – 5:00      Group Discussion   Q & A Day 1

Day Two
8:00-8:30      Continental Breakfast (provided)
8:30–9:30     Project Planning and Management
Susan Devine, CCRP, Research Consultant
Ms Devine will discuss project planning and management of pediatric research trials based on a project management approach.  Helpful templates geared to enhance efficiency will be shared.
9:30–10:30     Budgeting and Contracting for Pediatric Trials
Lisa Benson, BS, CCRP, CRCP, Vice President Clinical Research Operations, Quality and Education Institute for Advanced Clinical Trials for Children
Ms. Benson will discuss special considerations for developing pediatric research study budgets including a review of “hidden costs”.   Ms. Benson will present best practices for contract negotiation and payment collection.
10:30–10:45  Break and Opportunity for Discussion
10:45–11:45    Pediatric Clinical Trials – An Industry Sponsor Perspective
The speaker will discuss pediatric clinical trials from site selection to challenges faced from a industry sponsor’s perspective.    
11:45–12:30     Lunch (provided)    
12:30–2:30      Challenges in Pediatric Research
Janelle Allen, MS, CCRP, Assistant Project Manager,
Cincinnati Children’s Hospital Medical Center
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.
2:30–2:45    Break and Opportunity for Discussion
2:45 – 3:45  Developing Metrics in Pediatric Clinical   Trials
Amanda Galster,  MPH, CCRP, Director Clinical Research Program,  University of Minnesota Department of Pediatrics
Emily Owens Pickle, BS, CCRP, Pediatric Neuro-oncology Coordinator, Orlando Health, Arnold Palmer Hospital for Children
Susan Devine, CCRP, Research Consultant

Ms Galster, Owens Pickle and Devine will facilitate an interactive session to discuss metrics for pediatric clinical trials.  Discussion will include factors that affect study complexity and pediatric specific research processes that impact workload.  
3:45 – 4:30    Close Group Discussion
Q & A  Day 2 Sessions