12:00 - 12:30 Registration
12:30-1:30 Defining Success in a Centralized Clinical Trial Service Model
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
This presentation will outline the benefits and limitations of centralized and decentralized clinical trial management models for sites conducting clinical trials.
1:30-2:15 Opportunities Abound- The Clinical Research Career Pathway
Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Clinical Instructor of Practice, The Ohio State University, College of Nursing
This presentation will focus on providing you an overview of the multiple career pathways in clinical research. Many fall into this career, but how do we educate people on clinical research as a career option and then where you can go once in the profession. Attendees will walk away with skills they can apply to help market themselves for future job opportunities.
2:15- 2:30 Break
2:30- 3:15 Creative Solutions for Workforce Challenges
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
This presentation will outline opportunities for site leaders to get creative with some of the common staffing issues they face such as more projects than staff to manage them, staffing high activity/high acuity projects and having enough funding to keep staff when projects close.
3:15-4:00 Minimize your risk: developing a site quality plan
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Don’t wait for monitors or auditors to find your site compliance issues! This session will outline strategies for implementing peer review QA processes, identifying trends that require additional training and highlight suggestions for tracking and reporting on what is found to help foster an environment of compliance.
4:00-4:45 Promoting Site Success by Measuring Site Performance
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Ms. Wentzel will identify key performance indicators in clinical research and offer suggestions for how/why sites should measure them and how they can be used to justify additional resources.
8:00-8:30 Registration and Breakfast
8:30- 9:00 Introduction to Conference
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
9:00-10:45 Opening Plenary- The Childhood Cancer Data Initiative: An Exemplar of the Power of Data Sharing to Improve Cancer Outcomes
Gregory Reaman, MD, Scientific Director, Childhood Cancer Data Initiative (CCDI), Division of Cancer Treatment Diagnosis/OD, National Cancer Institute
10:45-11:00 Break
11:00-12:30 Practical Guidelines for Writing Research Informed Consent and Assent Documents
David Staley, Director, Clinical Research Quality Assurance and Regulatory Support, Seattle Children’s
Simplicity, clarity, and brevity are the best criteria for writing research informed consent and assent documents. Participants in this workshop will identify guidelines to capture the goals of this criteria. From there, they will use the guidelines and create a checklist to assess whether passages from informed consent and assent documents are simple, clear, and brief. Then, participants will apply the guidelines and their checklist to write clear, inviting, and meaningful sections of a consent or assent document. (Break 11:45-11:55)
12:30-1:15 Lunch
1:15- 2:00 A Pediatric Rare Disease Treatment Journey: From Idea to FDA Approval
Kandice Roush, RN, BSN, CCRC, Clinical Research Nurse, Nationwide Children’s Hospital
Ms. Roush will define rare diseases in pediatrics and an overview of the rare disease, Duchenne Muscular Dystrophy (DMD). We will review where we started in treatments of DMD, what we have learned along the way, and the advancements in treatments and FDA approvals over the last 15 years.
2:00- 2:45 Strategies for enrolling pediatric patients with a rare disease
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
This session will focus on discussing the challenges in pediatric rare disease studies and tactics for enrolling patients quickly and compliantly.
2:45- 3:00 Break
3:00- 4:00 Setting Up Your Study for Success
Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Clinical Instructor of Practice, The Ohio State University, College of Nursing
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.
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 Registration & Continental Breakfast
8:30-9:15 The Future of Gene Therapy for Pediatric Rare Diseases
Leah Johnson, MSN, RN, Gene Therapy Clinical Nurse Lead, Nationwide Children’s Hospital for Gene Therapy
Gene therapy for pediatric rare diseases has immensely developed from a possibility to a reality as evidenced by FDA approvals of Zolgensma and Elevidys. These two gene therapy treatments alone have brought back hope to millions of children and parents and these treatments will establish a foundation for the further development of gene therapy in multiple disease complexities. As the future of gene therapy expands, more research data is needed surrounding the efficacy and immune system responses.
9:15-10:00 Managing Con Meds, AEs and SAEs
Kandice Roush, RN, BSN, CCRC, Clinical Research Nurse, Nationwide Children’s Hospital
We will review the various ways for data capturing and follow up for AEs, conmeds and SAE’s and reporting requirements to institutional review boards. We will discuss the role and importance for external monitoring and methods safety issues are identified and managed during drug development and post marketing of new medications.
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, Executive Director, Site Operations, Javara
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 studies?
Mary Short, MSN, RN, Pediatric Research Consultant
Ms. Short will provide attendees with an overview of what sponsors seek when selecting sites for pediatric clinical trials. Presentation will include information on challenges of conducting pediatric research and facilitate discussion of site capabilities to overcome these challenges. Ms. Short will 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 Monitoring, FDA Audits, and Compliance in Pediatric Clinical Trials
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 Wrap Up and Questions