Convey: A Global Disclosure System

Convey: A Global
Disclosure System
Council of Science Editors
2015 Annual Meeting
Heather H. Pierce, JD, MPH
Senior Director, Science Policy
Regulatory Counsel
May 18, 2015
Institute of Medicine Report: Conflict of
Interest in Medical Research, Education,
and Practice
Recommendation 3.3
National organizations that represent academic medical
centers, other health care providers, and physicians and
researchers should convene a broad-based consensus
development process to establish standard content, a
standard format, and standard procedures for the
disclosure of financial relationships with industry.
2009
2011: IOM Holds a Multi-Stakeholder Event
Goal: Identify key elements necessary to enable a reporting
individual to provide data easily, and without repetition, to
organizations requesting disclosure of relationships.
Participants: 30 individual representatives
•
•
•
•
Academic Medicine
Journals
Government (FDA, CMS, NIH)
Professional Societies
•
•
•
•
CME Community
Industry
Consumer Groups
Physician Groups
Working Groups on Definitions and Data
Chaired by Allen Lichter (ASCO) and Ross McKinney (Duke)
1
2012: IOM Discussion Paper and JAMA
Editorial
“It is possible to create a more effective system for
reporting COI disclosures.”
“Substantial improvements can be made in the disclosure
system by creating a centralized data repository that is
governed in a manner that ensures data security while
reducing the burden of disclosure for individuals and
meeting the needs of all stakeholders.”
2013: IOM Convenes Implementation Working
Group
•
Develops strategies for implementation and
explores market and potential business model
•
Concludes that centralized disclosure system
as described in discussion paper is feasible
•
Asks AAMC to consider developing the system
Principles
•
Secure, user-controlled
•
Based on national data standards
•
Draws from single source of financial interests
•
Provides relevant disclosure information
based on organization criteria and user
assessment
•
Interoperable with COI management systems
•
Intuitive and easy to use for both individuals
and subscribing organizations
2
From IOM Recommendation to Prototype
•
Secure, user-controlled platform drawing from
single source of financial interests
•
Provides relevant disclosure information
based on organization criteria and user
assessment
•
Interoperable with COI management systems
- based on national data standards
•
Intuitive and easy to use for both individuals
and subscribing organizations
©
3