24 September 2009National Academies - BRDI1 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

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. 24 September 2009National Academies – BRDI2 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.” 24 September 2009National Academies – BRDI3

New Funding & Activities American 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 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 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 24 September 2009National Academies – BRDI4

5 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

6 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 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. Expected to expand over time to include additional collections in other high-interest biomedical fields. 24 September 2009National Academies – BRDI12

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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) 24 September 2009National Academies - BRDI17

BRDI Strategic Plan: Topics of Greatest Interest 1.Open Access Publishing 2.Sharing Scientific Data 3.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 6.Increasing Return on Investment in Publicly Funded Digital Science 7.Long-term Preservation and Availability of Data 8.Tracking of Information Flows among Databases 9.Interoperability 10.The End of “Just-in-Time” Experimentation 11.Meta-analysis 12.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 Online 15.US-China Roundtable on Scientific Data Cooperation 16.US–India Roundtable on Cooperation in Scientific Data and Information 24 September 2009National Academies – BRDI18

24 September 2009National Academies – BRDI19 More information on data/ information sharing at NIH NIH Data Sharing Policy NIH Public Access Policy NIH GWAS Policy ClinicalTrials.gov National Library of Medicine National Center for Research Resources