Four key solutions to address barriers for decentralizing trials to improve patient access
Archana Sah, CancerX Moonshot, shared a paper by Ramya Thota et al. on LinkedIn:
“Great to see this published today: American Society of Clinical Oncology (ASCO) research statement with four key solutions to address the regulatory and administrative barriers for decentralizing trials to improve patient access:
(1) FDA should engage the research community in a public-private partnership to modernize standards and enable local access to trials
(2) Sponsors and CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency
(3) Research centers, networks, and sites should update policies and procedures to implement decentralised trial elements
(4) Research community should develop a streamlined, uniform mechanism to simplify regulatory data collection and documentation and use it consistently across trials.”
Phuong Ly-Gallagher, Research Advocate Training and Support (RATS) Manager at Fight Colorectal Cancer, commented on Archana Sah’s post on LinkedIn, adding:
“And with each of these, measures should be taken to keep the patient and caregiver experience front and center to ensure that needs are met rather than adding burden.”
Source: Archana Sah/LinkedIn and Phuong Ly-Gallagher/LinkedIn
Authors: Ramya Thota, Patricia A. Hurley, Therica M. Miller, Suanna S. Bruinooge, Craig Lipset, R. Donald Harvey, Lora J. Black, Amanda Dinsdale, Janette K. Merrill, Teri Pollastro, Sheila A. Prindiville, Mujahid A. Rizvi, Shimere Sherwood, and Grzegorz S. Nowakowski.
