KHI Current Project

Pediatric Clinical Trials: Making Them Family-Centric

Problem Statement:

After the Pediatric Workshop conducted at the Kidney Health Initiative (KHI) Annual Stakeholder meeting, various needs were identified, particularly concerning gaps in educating and empowering families to participate in trials, as well as addressing the needs of industry companies conducting trials. In response, an internal group convened to explore strategies for the Kidney Health Initiative (KHI) to effectively tackle these identified gaps.

Project Goals:

Project Objectives

1. Develop a comprehensive resource guide for patients and caregivers to facilitate enrollment in clinical trials.
2. Address industry companies' analytical needs and bridge gaps in clinical trial protocol analysis.
3. Showcase achievements in conducting pediatric clinical trials via a webinar presentation.

Timeline

This project will be completed by December 2024.

Work Group #1

Objective: Develop a comprehensive resource guide for patients and caregivers to facilitate enrollment in clinical trials.

Co-Chair	Howard Trachtman	KHI Board Liaison
Co-Chair	Austin Lee	Patient Family Partnership Council Member, Workgroup Lead
Member	Mary Baliker	Patient Family Partnership Council
Member	Bonnie Schneider	IgA Nephropathy Foundation
Member	Andre Weinstock	Alport Syndrome Foundation
Member	David Feldman	National Kidney Foundation
Member	Tameka Sanders	BI
Member	Glenda Roberts	University of Washington
Member	Kevin Fowler	The Voice of the Patient

Deliverables Plan Create a resource that parents/caregiver will use to ask questions about a clinical trial and determine if their child will enroll in the trial.

Working Group #2

Objective: Address industry companies' analytical needs and bridge gaps in clinical trial protocol analysis.

Co-Chair	Howard Trachtman	KHI Board Liaison
Co-Chair	Lokesh Shah	Workgroup Co-Lead
Member	Jack Lennon	Workgroup Co-Lead, Patient Family Partnership Council
Member	Ogo Egbuna	Vertex Pharmaceuticals
Member	Jerome Rossert	AstraZeneca
Member	Dustin Little	AstraZeneca
Member	Margaret Dean	Fortrea
Member	Barbara Gillespie	Fortrea
Member	Mary Baliker	Patient Family Partnership Council

Deliverables Plan

• Conduct a focus group with industry members to determine the gaps/needs when conducting clinical trials.
• Analyze data and share in a new focus group with pediatric nephrologists to determine feasibility.
• Analyze data and share findings with patients/caregivers to determine feasibility.
• Analyze each focus group and present findings.

Working Group #3

Objective: Showcase achievements in conducting pediatric clinical trials via a webinar presentation.

Co-Chair	Howard Trachtman	KHI Board Liaison
Co-Chair	Lauren Lee	Workgroup Lead
Member	David Feldman	National Kidney Foundation
Member	Tameka Sanders	BI
Member	Margaret Dean	Fortrea
Member	Barbara Gillespie	Fortrea

Deliverables Plan Work with Workgroup lead to determine speaker, objectives of webinar, and date for webinar.