Literature DB >> 32943534

IDeA States Pediatric Clinical Trials Network for Underserved and Rural Communities.

Robert D Annett1, Sheva Chervinskiy2, Thomas H Chun3, Kelly Cowan4, Kristina Foster5, Nathaniel Goodrich6, Matthew Hirschfeld7, Daniel S Hsia8, J Dean Jarvis9, Kurtis Kulbeth2, Christi Madden10, Clare Nesmith11, Hengameh Raissy12, Judith Ross13, J Philip Saul14, Bruce Shiramizu15, Paul Smith16, Janice E Sullivan17, Lauren Tucker18, Andrew M Atz19.   

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.
Copyright © 2020 by the American Academy of Pediatrics.

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Year:  2020        PMID: 32943534      PMCID: PMC7786822          DOI: 10.1542/peds.2020-0290

Source DB:  PubMed          Journal:  Pediatrics        ISSN: 0031-4005            Impact factor:   7.124


  33 in total

1.  Special article: 2014 Pediatric Clinical Trials Forum.

Authors:  Clifford Bogue; Linda A DiMeglio; Samuel Maldonado; Ronald J Portman; P Brian Smith; Janice E Sullivan; Charles Thompson; Heide Woo; Susan Flinn
Journal:  Pediatr Res       Date:  2015-12-09       Impact factor: 3.756

2.  Early Development of Value of Information Methods.

Authors:  Stuart G Baker
Journal:  Med Decis Making       Date:  2018-11       Impact factor: 2.583

3.  Indigenous Research Ethics Requirements: An Examination of Six Tribal Institutional Review Board Applications and Processes in the United States.

Authors:  Nicole S Kuhn; Myra Parker; Clarita Lefthand-Begay
Journal:  J Empir Res Hum Res Ethics       Date:  2020-04-01       Impact factor: 1.742

4.  Tribal IRBs: A Framework for Understanding Research Oversight in American Indian and Alaska Native Communities.

Authors:  Deana Around Him; Temana Andalcio Aguilar; Anita Frederick; Heather Larsen; Michaela Seiber; Jyoti Angal
Journal:  Am Indian Alsk Native Ment Health Res       Date:  2019

5.  Environmental influences on Child Health Outcomes, a Research Program of the National Institutes of Health.

Authors:  Matthew W Gillman; Carol J Blaisdell
Journal:  Curr Opin Pediatr       Date:  2018-04       Impact factor: 2.856

6.  Evolution of Multidisciplinary Translational Teams (MTTs): Insights for Accelerating Translational Innovations.

Authors:  Kevin C Wooten; William J Calhoun; Suresh Bhavnani; Robert M Rose; Bill Ameredes; Allan R Brasier
Journal:  Clin Transl Sci       Date:  2015-03-19       Impact factor: 4.689

7.  The Pediatric Heart Network: a primer for the conduct of multicenter studies in children with congenital and acquired heart disease.

Authors:  L Mahony; L A Sleeper; P A W Anderson; W M Gersony; B W McCrindle; L L Minich; J W Newburger; J P Saul; V L Vetter; G D Pearson
Journal:  Pediatr Cardiol       Date:  2006 Mar-Apr       Impact factor: 1.655

Review 8.  Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features.

Authors:  Michael J Grayling; James M S Wason; Adrian P Mander
Journal:  Trials       Date:  2017-01-21       Impact factor: 2.279

9.  A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network.

Authors:  Gordon R Bernard; Paul A Harris; Jill M Pulley; Daniel K Benjamin; Jonathan Michael; Daniel E Ford; Daniel F Hanley; Harry P Selker; Consuelo H Wilkins
Journal:  J Clin Transl Sci       Date:  2018-11-27

10.  Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators.

Authors:  Thomas P Shanley; Nancy A Calvin-Naylor; Ruthvick Divecha; Michelle M Wartak; Karen Blackwell; Jonathan M Davis; Edward F Ellerbeck; Karl Kieburtz; Margaret J Koziel; Katherine Luzuriaga; Jennifer Maddox; Nancy A Needler; Susan Murphy; Kieran Pemberton; Catherine Radovich; Eric P Rubinstein; Harry P Selker; Pamela Tenaerts; Kelly Unsworth; Kay Wilson; Jonelle E Wright; Richard Barohn
Journal:  J Clin Transl Sci       Date:  2017-01-13
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  1 in total

1.  Capacity Building for a New Multicenter Network Within the ECHO IDeA States Pediatric Clinical Trials Network.

Authors:  Robert D Annett; Scott Bickel; John C Carlson; Kelly Cowan; Sara Cox; Mark J Fisher; J Dean Jarvis; Alberta S Kong; Jessica S Kosut; Kurtis R Kulbeth; Abbot Laptook; Pearl A McElfish; Mary M McNally; Lee M Pachter; Barbara A Pahud; Lee A Pyles; Jennifer Shaw; Kari Simonsen; Jessica Snowden; Christine B Turley; Andrew M Atz
Journal:  Front Pediatr       Date:  2021-07-14       Impact factor: 3.569

  1 in total

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