IDeA States Pediatric Clinical Trials Network for Underserved and Rural Communities

Abstract

The National Institutes of Health's Environmental Influences on Child Health Outcomes (ECHO) program aims to study high-priority and high-impact pediatric conditions. This broad-based health initiative is unique in the National Institutes of Health research portfolio and involves 2 research components: (1) a large group of established centers with pediatric cohorts combining data to support longitudinal studies (ECHO cohorts) and (2) pediatric trials program for institutions within Institutional Development Awards states, known as the ECHO Institutional Development Awards States Pediatric Clinical Trials Network (ISPCTN). In the current presentation, we provide a broad overview of the ISPCTN and, particularly, its importance in enhancing clinical trials capabilities of pediatrician scientists through the support of research infrastructure, while at the same time implementing clinical trials that inform future health care for children. The ISPCTN research mission is aligned with the health priority conditions emphasized in the ECHO program, with a commitment to bringing state-of-the-science trials to children residing in underserved and rural communities. ISPCTN site infrastructure is critical to successful trial implementation and includes research training for pediatric faculty and coordinators. Network sites exist in settings that have historically had limited National Institutes of Health funding success and lacked pediatric research infrastructure, with the initial funding directed to considerable efforts in professional development, implementation of regulatory procedures, and engagement of communities and families. The Network has made considerable headway with these objectives, opening two large research studies during its initial 18 months as well as producing findings that serve as markers of success that will optimize sustainability. A PEDIATRIC CLINICAL TRIALS NETWORKIn 1993, Congress mandated the establishment of the Institutional Development Awards (IDeA) Program to distribute funding for biomedical and behavioral research to geographical areas that had historically received low levels of support from the National Institutes of Health (NIH). 1 The IDeA program builds research capacities by supporting basic, clinical, and translational research, faculty development, and infrastructure improvements. The IDeA program further seeks to enhance the ability of investigators to compete successfully for research funding. Historically, the major components of the IDeA program

A capability framework to inform the fundamental requirements for clinical trial unit development, growth and long term success in outer metropolitan and rural areas

“…For example, in the United States of America (USA) efforts have largely focused on addressing recruitment barriers such lack of clinical trial awareness, and low referral activity [ [21] , [22] , [23] , [24] , [25] ]. Capacity building has been attempted by assessing the research experience and infrastructure of participating sites, including implementing local professional development and capacity building activities [ [26] , [27] , [28] ]. Such capacity building and mentoring have been successful in improving recruitment to clinical trials [ 29 , 30 ].…”

A mixed-methods analysis to understand the implementation of a multistakeholder research consortium: Environmental influences on child health outcomes (ECHO)

“…2 ). We did not include the interventional arm of ECHO, the IDeA States Pediatric Clinical Trials Network [ 16 ], as it does not utilize the same organizational structure and has different protocols and processes as a clinical trial arm. Finally, at the time of data collection, we could not identify representatives from the nascent Genetics Core for inclusion in the study.…”

Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures

“…Briefly, the trial was focused on recruiting up to 128 participants aged 6-12 years of age who reside in rural regions in one clinic in each of four states (DE, NE, SC, and WV). Each clinic was selected by their states' awardee site which are members of the Environmental Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) [13]. Criteria for the clinic's participation included having 40% of pediatric patient visits covered by Medicaid, having seen a minimum of 100 potential patients (rural, 6-11 years of age, and overweight or obese) within the past year, and having appropriate resources to recruit and enroll participants.…”