As Workshop chair, Dr Strom takes responsibility for the content of this article.
Risk assessment of drugs, biologics and therapeutic devices: present and future issues†
Article first published online: 22 MAY 2003
Copyright © 2003 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 12, Issue 8, pages 653–662, December 2003
How to Cite
Strom, B. L. (2003), Risk assessment of drugs, biologics and therapeutic devices: present and future issues. Pharmacoepidem. Drug Safe., 12: 653–662. doi: 10.1002/pds.859
- Issue published online: 2 DEC 2003
- Article first published online: 22 MAY 2003
- Manuscript Accepted: 25 MAR 2003
- Manuscript Revised: 18 MAR 2003
- Manuscript Received: 15 FEB 2003
- Agency for Healthcare Research and Quality (AHRQ). Grant Number: R13 HS12084
- CERTs cooperative. Grant Number: UL84510548
- risk assessment;
- health policy;
- regulatory agencies;
The current US system for detecting adverse effects of therapeutics (drugs, devices and biological products) is suboptimal. This report presents the results of an expert workshop on assessing therapeutic risks. This is the second of five workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) to address the management of therapeutic risks relative to potential benefits.
The workshop included academic, industry, government and constituency-based leaders. The focus was on the postapproval phase and procedures in the US, but relevant international issues and attendees were included.
Substantial deficiencies in the current US system for risk assessment were delineated. Improving the system will involve research into methods to improve risk assessment, enhancement and consolidation of data-handling systems, education of healthcare workers, allocation of financial resources and building of constituencies.
We need leadership on multiple levels for global coordination of risk assessment. We can then begin to fill gaps and produce benefits for industry, health authorities, government agencies, healthcare providers, and most important, the public. Copyright © 2003 John Wiley & Sons, Ltd.