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Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the ACRP to the U.S. Food and Drug Administration (FDA) in response to their recent draft guidance on DCTs.

As leaders in the clinical research enterprise seek to expand the public’s understanding of clinical trials and their potential benefits for healthcare at the personal, community, and national levels, communications tactics cannot remain stuck at the one-on-one rate of physician referrals or patient recruiters reaching out to individual potential volunteers for real progress to be seen.

A first-of-its-kind toolkit has been unveiled for providing a common framework, tools, and best practices for uniform ethical review and approval of decentralized clinical trials, as well as a roadmap for their ethical conduct.

To grow and diversify the clinical research workforce, Merck recently offered a group of students an Early Talent Training Program designed by the Association of Clinical Research Professionals. The program aims to introduce students in high school and community college settings to the clinical research profession, offering a core research curriculum necessary to establish the knowledge base needed to enter the profession at an entry level.

To ensure clinical trial billing compliance, research professionals should inspect their program, measure risks, and assemble the team members who can make billing compliance better.