Journal Editors Should Encourage Disclosures of CDRH's Role in Trial Designs: JAMA Viewpoint
Posted 07 November 2017 | By
Medical and research journal editors should encourage research authors to disclose the role of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in clinical trial design and execution, Aaron Kaplan of the Heart & Vascular Center at Dartmouth-Hitchcock Medical Center and Ariel Stern of Harvard Business School, wrote in a JAMA viewpoint.
Kaplan and Stern offer four main reasons for consistently disclosing FDA/CDRH involvement in designing and executing pivotal trials:
- In scientific research, a significant contribution traditionally requires acknowledgment and transparency.
- Reporting FDA/CDRH involvement and on the premarket approval process will provide "a clear signal that a study was conducted to a regulatory standard, which in many ways exceeds the already high standards that are required for publication in top-tier, peer-reviewed journals."
- Highlighting the context and FDA’s intent to evaluate a specific device "allows for a better understanding of the study and facilitates a more nuanced understanding of the regulatory approval process for practitioners."
- And pivotal trial completion represents the culmination of a large effort to bring a new device into the market place, which the authors say can cost upwards of $100 million.
"Finding balance in medical device regulatory policy is an important public health issue that demands an informed public debate," the authors say. "Central to this debate is an understanding of the role of FDA/CDRH in this process and the regulatory science of new high-risk device approvals."
The authors also noted that more transparency on CDRH involvement will facilitate more open and better discussions around the subsequent clinical adoption of new medical technologies.
The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials