8:00- 8:30 Registration and Breakfast
8:30- 9:00 Introduction to Conference
Grace Wentzel, BA, CCRP, CHRC, Deputy Director, Operations, SOAR, The Ohio State University
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
9:00-10:00 Opening Plenary - Pediatric Mental Health Research – Myths, Facts, Challenges and Opportunities
Molly McVoy, MD, Associate Professor, Psychiatry Case Western Reserve University of Medicine
A mental health crisis is facing our youth in the last decade and this talk will give an overview of the state of mental health in pediatrics in the US and the research developments over the same period of time (the last decade). Challenges that are unique to pediatric mental health research will be discussed, in addition to unique opportunities and research on the horizon with the pediatric mental health space.
10:00-10:15 Break
10:15-11:00 Kids vs. Adults in Clinical Research
Grace Wentzel, BA, CCRP, CHRC, Deputy Director, Operations, SOAR, The Ohio State University
Ms. Wentzel will outline commonalities and distinctions between clinical research involving children vs. Adults.
11:00-11:45 Pediatric Regulations, Informed Consent and Assent in Challenging Populations
Grace Wentzel, BA, CCRP, CHRC, Deputy Director, Operations, SOAR, The Ohio State University
Ms. Wentzel will define those regulations specific to pediatrics and discuss challenges and solutions when consenting and assenting pediatric participants.
11:45-12:30 Workshop- Let’s Write a Consent/Assent Form That is Understandable
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Grace Wentzel, BA, CCRP, CHRC, Deputy Director, Operations, SOAR, The Ohio State University
Ms. Benson and Ms. Wentzel will outline ways in which sites can modify their consent and assent forms to maximize readability and comprehension.
12:30- 1:15 Lunch
1:15- 2:00 Feasibility- Can Your Site Really Do This Study?
Jessica Fritter, DHSc, MACPR, ACRP-CP, Assistant Professor, The Ohio State University
In this session, we will delve into the critical concept of clinical research feasibility, addressing the essential question: "Can your site truly execute this study?" As clinical trials become increasingly complex, understanding the feasibility of conducting a study at a specific site is vital for successful outcomes.
2:00- 2:45 Setting Your Study Up for Success
Jessica Fritter, DHSc, MACPR, ACRP-CP, Assistant Professor, The Ohio State University
When tasked with starting a new study, it can feel overwhelming. Where do you begin? This presentation is going to break down the startup process that will help ensure study success. We will discuss how to adequately review the protocol and source documents, list the documentation needed, discuss how to identify obstacles that may occur and the importance of communication amongst the study teams. Be ready to leave this session feeling prepared with your very own checklist.
2:45- 3:00 Break
3:00- 4:00 Recruitment, Enrollment & Retention of Pediatric Participants
Grace Wentzel, BA, CCRP, CHRC, Deputy Director, Operations, SOAR, The Ohio State University
Ms. Wentzel will discuss who participates in research studies and possible ways to increase recruitment. Once enrolled, significant efforts need to be made to maintain the child’s and parents’ attention and interest throughout the study. Ms. Wentzel will discuss the challenges to retention and elements to improve retention.
4:00- 5:00 Round Table Discussions
Course Faculty
Course Faculty will lead an interactive discussion on key insights discussed in this days’ session.
8:00- 8:30 Breakfast
8:30-9:15 Bedside Nurse to Pediatric Clinical Research Nurse: Lessons Learned
Leah Johnson, MSN, RN, Gene Therapy Nurse Lead, Center for Gene Therapy, Nationwide Children’s Hospital
As inpatient bedside nurses, we continuously strive to complete our patient tasks assigned to us for a 12-hour period (patient assessment, wound care, medication administration, review of orders, etc.) We clock in and clock out with each new shift requiring a change in patients and acuity but once clocked out, our nursing care is complete. Making the change to research nursing can often be a complete shock to our previous nursing experience and outlook. It is imperative for new research nurses to prioritize obtaining a new mindset and expectations that is quite frankly, the opposite of bedside nursing. The to-do lists aren’t checked off at the end of each shift and patient care is now centered on research safety, changing standard of care for many rare diseases and long term follow up/risk assessment.
9:15-10:00 Tales of a Pediatric Clinical Research Nurse; the Lengths We Will Go to For High Quality Data
Leah Johnson, MSN, RN, Gene Therapy Nurse Lead, Center for Gene Therapy, Nationwide Children’s Hospital
Discuss ways research nurses can help decrease protocol deviations and manage expectations for all involved in the research. Provide helpful tips on ways to promote adherence to pediatric protocols and measures that nurses are willing to do to get quality data, and still ensure safety and patient satisfaction.
10:00-10: 15 Break
10:15-12:00 Budgeting, Contracting and Financial Compliance in Pediatric Trials
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Ms. Benson will discuss special considerations for developing pediatric clinical trial budgets including a review of "hidden costs" that tend to be overlooked in the pediatric population. She will also discuss strategies for contract negotiations and timely payment collection.
12:00-12:45 Lunch
12:45-1:30 How to Develop a Pediatric Clinical Trial Study Budget
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Grace Wentzel, BA, CCRP, CHRC, Deputy Director, Operations, SOAR, The Ohio State University
Ms. Benson and Ms. Wentzel will provide a hands on approach for participants to develop a study budget. Participants will be given a mock protocol, tools and budget template to review.
1:30-2:30 How to Attract More Industry Sponsored Pediatric Studies
Edress Darsey, PharmD, FPPA, Executive Director, Clinical Development Strategy, Pediatrics, PPD/ThermoFisher
Dr. Darsey will provide attendees with an overview of what sponsors seek when selecting sites for pediatric clinical trials. She will include information on challenges of conducting pediatric research and facilitate discussion of site capabilities to overcome these challenges. Dr. Darsey will also discuss industry initiatives to improve the site experience.
2:30 - 2:45 Break
2:45 - 3:45 Round Table Discussions
Course Faculty
Course Faculty will lead an interactive discussion on key insights discussed in this days’ session.
3:45 – 4:30 Preparing for an Audit (FDA)
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Minimizing risk through good clinical practice is well known when conducting clinical research. This presentation will focus on the importance of self-monitoring and preparing for audits whether it’s Sponsor, FDA, or COG initiated. Ms. Benson will also review the importance of financial compliance relating to pediatric trials.
4:30 – 4:45 Q&A and Discussion