Regulatory Affairs
Bringing members together to proactively address the regulatory barrier to adoption of decentralized methods
DTRA Regulatory Affairs Council
This group meets monthly to proactively address regulatory documents and concerns related to the conduct of decentralized methods. Contact us if you think you could be a great fit for this Council, and currently are part of an Organization that is a DTRA member.
ICH E6 R3 Roundtable Discussion
February 11, 2025
DTRA Community met to discuss the ICH E6 R3 Annex 2 document and it's implementation and implications.
Speakers: Eric Delente (Medidata), Deb Guattery (Chase The Sky for Quality LLC), and Maddy Whitehead (Roche)
Randomized Controlled Trials for Drug & Biological Products Into Routine Clinical Practice
October 24, 2024
DTRA Community met to discuss this guidance document from the FDA and support the conduct of randomized controlled drug trials with streamlined protocols and procedures.
Speakers: Matt Veatch and Aaron Kamauu (Navidence)
Diversity Action Plan Guidance Roundtable
September 8, 2024
DTRA Community met to discuss the Diversity Action Plan Guidance document from the FDA and the form, content, and manner of diversity action plans.
Speakers: Donna Hanson (Advanced Clinical), Kristi Robertson (Lilly), Rasika Kalamegaham (Roche), and Angela Radcliffe (Heartbeat Clinical)
Conducting Trials with DCT Elements Roundtable
July 13, 2023
DTRA Community met to discuss the Conducting Trials with DCTs Elements Draft Guidance from FDA. This document provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
Speakers: Rasika Kalamegaham (Genentech), Leanne Madre (Medable), Rebecca Kottschade (Mayo Clinic), and Jonathan Andrus (CRIO)
NIH NCATS | Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials RFI
April 24, 2023
DTRA Community met to discuss the Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials RFI document from the NIH and to share how DCTs may be designed to be more effective, efficient and equitable to bring more interventions to all people, faster.
Speakers: Rasika Kalamegham (Genentech), Mo Ali (Astellas) Molly Klote (VA)Veterans Health Administration, Alicia Staley (Medidata), Melissa Holbrook (Velocity Clinical Research) ,Munther Baara (Edetek), Rebecca Kottschade (Mayo Clinic), Vik Kheterpal (CareEvolution), Shaalan Beg (NIH), Sandeep Bhat (GSK)
OSTP/ONC Listening Session on Emergency Clinical Trials RFI
January 23, 2023
DTRA Community met to discuss the Clinical Research Infrastructure and Emergency Clinical Trials document. This document ensures that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies
Speakers: Otis Johnson (Trial Equity, Dr. Tufia Haddad (Mayo Clinic), Ryan Brown (Circuit Clinical), Kendal Whitlock (Walgreens), Steve Walker (CSL Behring), Mo Ali (Astellas), Mark Brown (IQVIA), Rasika Kalamegaham (Genentech), Josh Rose (Hawthorne Health), Caroline Redeker (Advanced Clinical) Hassan Kadhim (Vertex Pharmaceuticals), John Reites (THREAD)