The Georgia Clinical & Translational Science Alliance - Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI collaborate to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Course Description:

A general overview of pediatric trials, discussing pediatric subpopulations, laws related to pediatric research, the consent process, and clinical trial design considerations.The level of cognitive ability of developing children, ethics, the physiological changes associated with human growth, and data biases associated with age will be highlighted. A case study investigating the effects of caffeine on newborns and whether breast feeding versus formula feeding affected caffeine metabolism differently is presented.

Learner Objectives:

At the end of this course, the learner will be able to:

1. Identify the laws promoting pediatric participation in clinical research.
2. Distinguish between the diverse sub-populations that comprise the pediatric population.
   • Define terms related to pediatric participation in research (i.e., parental permission, assent, and consent)
   • Identify two complexities unique to pediatric clinical research and recruitment bias.

Course Topics:

1. Pediatric trials are hard, so why do them?
2. Who are “Children”?
3. Assent vs. Consent
4. How do logistics and recruitment bias data?
   • Children five years of age and older are legally required to attend school
   • Parent/guardian’s stigma and biases about allowing their child to participate in research
   • Eliciting children’s participation especially for research involving interviews, questionnaires, surveys, and other tools with both qualitative and quantitative elements
5. Example: Studying caffeine in newborns
6. Are my outcomes measurable in this child?

Speaker:

Matthew Borzage, PhD, is an Assistant Professor of Research Pediatrics, Keck School of Medicine of USC and a faculty researcher at the Children’s Hospital of Los Angeles with an interest in neurodevelopment and a focus on flow of cerebrospinal fluid and blood in the brain. He holds a MS and PhD in Biomedical Engineering from USC. His primary training as a biomedical engineer enables him to work with the critical technologies of noninvasive data acquisition of cerebrospinal fluid and near infrared spectroscopy with classic analysis techniques for these technologies and to have a critical working knowledge of the nature of pathophysiologies that commonly impact flow in the brain, including disrupted cerebrospinal fluid flow via Chiari malformations, spina bifida, post intraventricular hemorrhagic hydrocephalus, and more. Combining his research interests and capabilities enables understanding the physiology that underlines some of the most devastating neurological pathologies. He has authored over 25 research publications. His current work focuses on shunt-responsive hydrocephalus and individual cerebral hemodynamic and oxygenation relationships. borzage@usc.edu

Learner Level: Intermediate

Audience: This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
• Review the entire activity
• Pass the quiz with 100% of questions answered correctly
• Complete the evaluation at the end
• Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
• Start Date: 09/30/2022
• Expiration Date: 09/29/2025

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.