Transcript Research Data and Information: New Developments at NIH Jerry Sheehan Assistant Director for Policy Development National Library of Medicine National Institutes of Health National Academies Board on.

Research Data and
Information: New
Developments at NIH
Jerry Sheehan
Assistant Director for Policy Development
National Library of Medicine
National Institutes of Health
National Academies Board on Research Data and Information
September 24, 2009, Washington, DC
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New NIH Director
Francis S. Collins,
M.D., Ph.D.
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Broad Themes & Special Opportunities
1. Apply high-throughput technologies to
understand fundamental biology and
uncover the causes of specific disease
states. “Ask questions that have the word
ALL in them”
2. Translation – knowledge of disease into
prevention, diagnostic, therapeutics.
3. Put science to work for health care reform
(e.g., produce data to inform decisionmaking).
4. Greater focus on global health.
5. Reinvigorate and empower the biomedical
research community.
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On the Role of Data
“[High throughput technologies] provide us with the
opportunity to ask questions that have the word
‘ALL’ in them. What are ALL the transcripts in a
cell? What are ALL the protein interactions? . .
Those kinds of questions are now approachable,
especially if we do the right job of making really
powerful databases publicly accessible to all those
who need them and empower investigators in
small labs as well as big labs to plunge into that
kind of mindset.”
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New Funding & Activities
American Recovery and Reinvestment Act (ARRA)
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NIH-funded research -- $8.2 billion
Facilities, instrumentation, construction -- $1.8 billion
Comparative Effectiveness Research: $400 million
Will result in more and new kinds of data
Health IT for Economic and Clinical Health (HITECH) Act
[Title XIII of ARRA]
• Office of National Coordinator for Health IT and 2 Advisory Committees
(Policy and Standards)
• Financing purchases of HIT
– Medicare/Medicaid incentives/penalties for “meaningful” use of HIT
– Grants to States for low interest loans to care providers
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Privacy and security
Testing and certification of HIT products
Research and education programs
Health IT infrastructure, including extension centers
Considerable work on data standards and interoperability
Potential for electronic health records as source of data for research
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New Data: Clinical Trial
Basic Results Information
Submission of summary results information required for
“applicable clinical trials” of approved drugs, biologics,
and devices starting Sept 27, 2008
• Demographic & baseline characteristics
– Table of values, overall and for each arm
– # of patients dropped out & excluded from analysis
• Primary and secondary outcomes
– Table of values for each primary & secondary outcome measure,
by arm
– Scientifically appropriate tests of statistical significance
• Point of contact (for scientific information)
• Certain agreements (restrictions on PI to discuss or
publish results after trial completion date)
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More New Data: Clinical Trial
Adverse Events Information
Mandatory with Results starting Sept 27, 2009
• SERIOUS ADVERSE EVENTS
– Table of anticipated and unanticipated serious adverse
events
– Grouped by organ system
– Number and frequency of event in each arm of clinical trial
• FREQUENT ADVERSE EVENTS
– Table of anticipated and unanticipated adverse events
– Exceed a frequency of 5 percent within any arm of clinical
trial
– Grouped by organ system
– Number and frequency of event in each arm of clinical trial
• Information to help interpret AE information
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New Information Service:
Rapid Research Notes
www.ncbi.nlm.nih.gov/rrn
• Archive of research made available through emerging
online venues for rapid scientific communication.
• Material provided through participating publisher
programs designed for immediate communication and
provided a stable identifier.
• Submissions not formally peer reviewed, but screened
by expert group for suitability.
• Initial content from PLoS Currents: Influenza
<www.ploscurrents.org/influenza>.
• Expected to expand over time to include additional
collections in other high-interest biomedical fields.
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Continuing NIH Interests in
Research Data & Information
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How to recognize and reward data sharing by researchers
– Consideration in promotion and tenure decisions
– Recognition by peers, funding agencies
– E.g., metric to measure citations of electronically published data that could be used by
tenure committees
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How to embed informatics/data sharing in training programs for scientists/
researchers
– Current approach ad hoc, based on apprenticeship
– Inclusion in training/education of principles of data collection, data curation, and sharing
– Roles of institutional libraries and individual labs, departments
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Development of a research agenda for management of scientific data and
information
– Take advantage of ongoing trends in information and communications technology
– Identify research areas in which investments by agencies such as NIH, NSF improve
scientific data/info management
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Promotion of effective approaches for data sharing
– Development of agency and institutional policies, scientific community practices
– Strategies and good practices for encouraging data sharing among researchers
– Identification of necessary resources and infrastructure (e.g., centralized repositories,
distributed databases, registries, standards)
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BRDI Strategic Plan:
Topics of Greatest Interest
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Open Access Publishing
2. Sharing Scientific Data
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Principles for Data Management and Publication in Public-Private Research
Partnerships
4. Effects of New Data Technologies on the Culture of Science
5. Managing Partially Restricted Databases
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Increasing Return on Investment in Publicly Funded Digital Science
Long-term Preservation and Availability of Data
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Tracking of Information Flows among Databases
Interoperability
The End of “Just-in-Time” Experimentation
Meta-analysis
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Econometric Data for Globalized Markets
13. Data in the Classroom
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Assessing the Economic and Social Effects of Open Access to Scientific Data and
Literature Online
US-China Roundtable on Scientific Data Cooperation
US–India Roundtable on Cooperation in Scientific Data and Information
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More information on data/
information sharing at NIH
NIH Data Sharing Policy
http://grants.nih.gov/grants/policy/data_sharing/
NIH Public Access Policy
http://publicaccess.nih.gov/
NIH GWAS Policy
http://grants.nih.gov/grants/gwas/
ClinicalTrials.gov
http://www.clinicaltrials.gov
National Library of Medicine
http://www.nlm.nih.gov
National Center for Research Resources
http://www.ncrr.nih.gov
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