Virtual Public Meeting on Good Clinical Practice: Considerations for Clinical Trials with Decentralized or Pragmatic Features

The U.S. Food and Drug Administration, in collaboration with the Reagan-Udall Foundation for the FDA, will convene international experts in the conduct of clinical trials with pragmatic or decentralized features. Clinical trials with streamlined protocols that are embedded in existing health care infrastructure (often referred to as pragmatic trials), and trials with decentralized processes have the potential to generate evidence more efficiently while minimizing the burden on participants.

Representatives from the research community will share their experiences conducting clinical trials with pragmatic or decentralized features. The two-day virtual public meeting will include presentations and moderated discussion to provide a better understanding of the opportunities and challenges of conducting trials with these innovative design features. Learnings from the meetings will inform the development of responsive policies and guidelines that encourage innovation, while protecting participants and safeguarding the reliability of trial results.

You can contribute to the discussion. Share your questions when you register, and as many as possible will be included in the discussion.

The meeting agenda is available and will be updated as more information is provided. Full recordings of both sessions will be available after the meeting along with the complete slide deck and transcript.

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AAP-SPROUT Tele-inpatient ECHO: Virtual inpatient subspecialty consults

The American Academy of Pediatrics is recruiting hospitalists, pediatricians, and other health professionals to be a part of the SPROUT (Supporting Pediatric Research on Outcomes and Utilization of Telehealth) Tele-inpatient ECHO (Extension for Community Healthcare Outcomes). This ECHO, in partnership with the SPROUT-CTSA Network, will serve as a forum for increasing knowledge, skills, and self-efficacy regarding effective strategies and best practices related to telehealth in the hospital setting.

Project ECHO® is an innovative hub and spoke program, designed to create knowledge networks by connecting health care providers with an expert team through a tele-mentoring program using brief lectures and case‐based presentations. This ECHO, in partnership with the SPROUT-CTSA Network, will serve as a forum for increasing knowledge, skills, and self-efficacy regarding effective strategies and best practices related to telehealth in the hospital setting.

The AAP-SPROUT Tele-inpatient ECHO will meet monthly September 2023 through February 2024 at at 12 PM ET on the following dates: September 13, October 11, November 15, December 13, January 10, and February 14. Participants are eligible to claim CME/MOC 2 credits.

September 13, 2023 topic: Virtual inpatient subspecialty consults | Presenter: Christina Olson, MD | Facilitator: Jordan Vaughn, MD, FAAP

Questions? Email Robinn Yu, Program Manager of ECHO Initiatives, This email address is being protected from spambots. You need JavaScript enabled to view it.

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This project was supported in part by NIH/ NCATS SPROUT-CTSA Collaborative Telehealth Network Grant Number U01TR002626. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.