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Research Data and Information: New Developments at NIH

Jerry SheehanAssistant Director for Policy DevelopmentNational Library of MedicineNational Institutes of Health

National Academies Board on Research Data and Information September 24, 2009, Washington, DC

New NIH Director

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 decision-making).

4. Greater focus on global health.5. Reinvigorate and empower the biomedical

research community.

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Francis S. Collins, M.D., Ph.D.

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 & ActivitiesAmerican Recovery and Reinvestment Act (ARRA)•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 dataHealth 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

•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

• 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)

Submission of summary results information required for “applicable clinical trials” of approved drugs, biologics, and devices starting Sept 27, 2008

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More New Data: Clinical Trial Adverse Events Information

• 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

Mandatory with Results starting Sept 27, 2009

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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

• 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• 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

• 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• 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

1. Open Access Publishing

2. Sharing Scientific Data3. Principles for Data Management and Publication in Public-Private Research

Partnerships

4. Effects of New Data Technologies on the Culture of Science5. Managing Partially Restricted Databases6. Increasing Return on Investment in Publicly Funded Digital Science7. Long-term Preservation and Availability of Data

8. Tracking of Information Flows among Databases9. Interoperability10. The End of “Just-in-Time” Experimentation11. Meta-analysis12. Econometric Data for Globalized Markets

13. Data in the Classroom 14. Assessing the Economic and Social Effects of Open Access to Scientific Data and

Literature Online15. US-China Roundtable on Scientific Data Cooperation16. 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 Policyhttp://grants.nih.gov/grants/policy/data_sharing/

NIH Public Access Policy http://publicaccess.nih.gov/

NIH GWAS Policyhttp://grants.nih.gov/grants/gwas/

ClinicalTrials.govhttp://www.clinicaltrials.gov

National Library of Medicinehttp://www.nlm.nih.gov

National Center for Research Resourceshttp://www.ncrr.nih.gov