The Office of Science and Data Policy is the departmental focal point for policy research, analysis, evaluation, and coordination of department-wide public health science policy and data policy activities and issues. The Office provides authoritative advice and analytical support to the ASPE and departmental leadership on public health science policy and data policy issues and initiatives, coordinates science and data policy issues of interagency scope within HHS, and manages interagency initiatives in science policy and data policy. The Office works closely with staff from across the Department on strategic plan development and implementation efforts. The Offices also carries out a program of policy research, analysis, evaluation, and data development in these issues.
The Office of Science and Data Policy includes several components:
- Biomedical research and development
- Economic analysis
- Emergency preparedness, response, and recovery
- Data and statistical policy
- Health disparities and vulnerable populations
- Health information technology
Acknowledgements This paper was prepared for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services (HHS), by David Cutler (Harvard University), Amber Jessup (ASPE/HHS), Donald Kenkel (Cornell University), and Martha Starr (U.S. Food and Drug Administration and American University). The contributions of Dr. Cutler and Dr. Kenkel were funded through subcontracts with Mathematica Policy Research. Amber Jessup is the HHS Project Manager.
Federal agencies have a long history of releasing data to the public, and they also have a legal obligation to protect the confidentiality of the individuals and organizations from which the data were collected. Federal agencies have successfully balanced these two objectives for decades. With the new emphasis on expanding public access to federal data, coupled with the increasing availability of data from other sources, federal agencies are continuing to ensure that the combination of data already available and the data they are preparing to release does not enable the identification of individuals or other entities through what has been termed the "mosaic effect." The concept of a mosaic effect is derived from the mosaic theory of intelligence gathering, in which disparate pieces of information become significant when combined with other types of information. To gain more insight into the mosaic effect and its implications for the continued release of data to the public while minimizing the risk of disclosing personal information, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) in the U.S. Department of Health and Human Services (HHS) contracted with Mathematica Policy Research to convene a technical expert panel (TEP), prepare background materials, and summarize what was learned from the panel discussion and the background research in a final report.
Pharmaceutical companies conduct clinical trials for many reasons. The most obvious goal of clinical trials is to demonstrate safety and efficacy to gain Food and Drug Administration (FDA) approval. FDA provides guidance to developers about what constitutes acceptable clinical trials and appropriate outcomes. Improving the drug development process, especially by conducting better (meaning providing more information on safety or efficacy) and faster clinical trials, can foster innovation in medical product development. The primary purposes of this study: 1) to better understand sponsors' strategies in the design and execution of clinical trials, 2) to identify factors that may delay, hinder, or lead to unsuccessfully completed trials, and 3) to develop an operational model of clinical trial decision-making to enable examination of what-if scenarios by end-users. This study models the decision-making process for a drug sponsor as a stylized decision tree that looks at the process for formulating a clinical trial from the point of view of an expected-revenue-maximizing sponsor in the face of uncertainty (or risk). The simplified clinical decision-making model incorporates the following considerations: * Therapeutic area * Potential market size/revenues for the drug * Clinical stage * Success probabilities by clinical stage In addition to identifying the costs of the clinical trials, the following barrier mitigation strategies were analyzed: * Use of electronic health records (EHR) * Looser trial enrollment restrictions * Simplified clinical trial protocols and reduced amendments * Reduced source data verification (SDV) * Wider use of mobile technologies, including electronic data capture (EDC) * Use of lower-cost facilities or at-home testing * Priority Review/Priority Review vouchers * Improvements in FDA review process efficiency and more frequent and timely interactions with FDA Overall, the therapeutic area with the highest clinical research burden across all phases is respiratory system ($115.3 million) followed by pain and anesthesia ($105.4 million) and oncology ($78.6 million) trials. Use of lower-cost facilities/in-home testing and wider use of mobile technologies appear to be most effective in reducing costs across therapeutic areas and trial phases. Use of lower-cost facilities and/or in-home testing can reduce per-trial costs by up to $0.8 million (16 percent) in Phase 1, $4.3 million (22 percent) in Phase 2, and $9.1 million (17 percent) in Phase 3, depending on therapeutic area.
Antibacterial resistance is a growing global problem. At least 2 million people in the U.S. acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat it. Despite the potential of new antibacterial products to reduce the social burden associated with resistant infections, development of antibacterials has been limited by insufficient return to capital invested in development of these products. This study, conducted by ERG develops an analytical decision-tree model framework that can be used to assess the impacts of different possible market incentives on the private and social returns to product development of new antibacterial products. ERG evaluated the private and social returns associated with the development of antibacterial drugs for acute bacterial otitis media (ABOM), acute bacterial skin and skin structure infections (ABSSSI), community acquired bacterial pneumonia (CABP) complicated intra-abdominal infections (CIAI), complicated urinary tract infections (CUTI), hospital acquired/ventilator associated bacterial pneumonia (HABP/VABP); a new vaccine effective in preventing ABOM; and a new rapid point-of-care diagnostic designed to identify MRSA. For antibacterial drugs, the average private return ranges from -$4.5 million (HABP/VABP) to $37.4 million (CABP). The average social value for the development of antibacterial drugs, however, ranges from a low of $486.6 million (ABOM) to a high of $1.217 billion (HABP/VABP). The private and social value for a new ABOM vaccine was estimated at $515.1 million and $2.281 billion, respectively. Similarly, the private and social value for new rapid point-of-care diagnostic designed to identify methicillin-resistant Staphylococcus aureus (MRSA) that can cause serious infections is estimated at $329.0 million and $22.1 billion, respectively. The gap between the current private and social values of drug development suggests that incentives are desirable to stimulate the development of drugs to treat the six indications considered. It is also important to note that simultaneous institution of conservation mechanisms, such as education campaigns to promote prudent use, and other stewardship programs, are likely to alter the incentive levels identified in this study.
Research Addressing the HHS Strategic Framework on Multiple Chronic Conditions Contract # HHSP2333700IT September 20, 2013 Prepared for: James Sorace, MD, MS Michael Millman, PhD Assistant Secretary for Planning and Evaluation U.S. Department of Health & Human Services 200 Independence Ave. S.W. Washington, DC 20201 Prepared by: Lisa LeRoy, MBA, PhD Melanie Wasserman, PhD Alan White, PhD
This paper presents a comparative framework of rapid evaluation methods for projects of three levels of complexity: quality improvement methods for simple process improvement projects; rapid cycle evaluations for complicated organizational change programs, and systems-based rapid feedback methods for large-scale systems change or population change initiatives. The paper provides an example of each type of rapid evaluation and ends with a discussion of rapid evaluation principles appropriate for any level of complexity. The comparative framework is designed as a heuristic tool rather than a prescriptive how-to manual for assigning rapid evaluation methods to different projects.
Assessing the Status and Prospects of State and Local Health Department Information Technology Infrastructure
ASPE REPORT Assessing the Status and Prospects of State and Local Health Department Information Technology Infrastructure January 2013 By: NORC at the University of Chicago Abstract
Evaluation Planning and Tools for Front of Package Nutrition LabelingFinal Report September 2012 By Andrea S. Anater Kelly Wohlgenant Sheryl Cates James Hersey Mary K. Muth, Dan Zaccaro, Chen Zhen RTI International Prepared for: Kathleen Koehler Office of Science and Data Policy Office of the Assistant Secretary for Planning and Evaluation (ASPE) Department of Health and Human Services Abstract
ASPE ISSUE BRIEF Health Care Cost Containment and Medical Innovation May 2012 By: Amber Jessup, Ph.D.
ASPE REPORT A Review and Analysis of Economic Models of Prevention Benefits April 2013 By: Wilhelmine Miller, David Rein, Michael O’Grady, Jean-Ezra Yeung, June Eichner, and Meghan McMahon Abstract
Guide to HHS Surveys and Data Resources Office of the Assistant Secretary for Planning and Evaluation U.S. Department of Health and Human Services
The HHS Hubert H. Humphrey Building Cafeteria Experience: Incorporation of the Dietary Guidelines for Americans, 2010 into Federal Food Service Guidelines.
ASPE Report The HHS Hubert H. Humphrey Building Cafeteria Experience: Incorporation of the Dietary Guidelines for Americans, 2010 into Federal Food Service Guidelines May 2012 By: Alycia Infante Bayne, Elizabeth Hair, Karen Harris Brewer, Arika Garg Abstract
On Friday, November 16, 2012, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) ofthe U.S. Department of Health and Human Services hosted a one-day meeting at the Department titled "Demystifying Microsimulation." The meeting consisted of a panel of experts who discussed what information consumers of microsimulation models need from modelers in order for consumers to understand and evaluate model results. The primary focus of the meeting was on educating consumers of models and helping them to understand model output and validity.
EXECUTIVE SUMMARY Contents Introduction and Background Data Needs and Priorities Research and Development to Improve HHS Data Collection Systems Web Panels and Web Surveys Timeliness of HHS Data Systems Access to HHS Data Non-Traditional Data Sources
HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status
U.S. Department of Health and Human Services Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status October 2011 This guidance is available on the Internet at:http://aspe.hhs.gov/datacncl/standards/ACA/4302
An Assessment of the State of the Art for Measuring Burden of Illness Final Report April 2011 Prepared for: Ansalan Stewart U.S. Department of Health and Human Services Prepared by: Amanda A. Honeycutt, Thomas Hoerger, Alex Hardee, Linda Brown, and Kevin Smith RTI International RTI Project Number: 0212050.005.001 This report is available on the Internet at:http://aspe.hhs.gov/sp/reports/2011/BurdenOfIllness/index.shtml
Policy Research for Front of Package Nutrition Labeling: Environmental Scan and Literature Review Final Report February 2011 Contract No. HHSP23320095651WC
ASPE ISSUE BRIEF Expanding the Use of Generic Drugs By: ASPE Staff December 1, 2010
This report reviews important lessons learned from the experience of network-enabled health IT adoption among federally funded health centers. It reviews challenges and opportunities associated with adoption of health IT, perceived costs and benefits and the experiences of providers working to leverage health IT to improve quality and efficiency of care. It also addresses the nature of support and technical assistance required at various stages of health IT adoption and the role networks have played in addressing those needs among federally funded health centers.
Web-based Information Exchange and Information Services Concept to Support the Exchange of Newborn Screening Information
Web-based Information Exchange and Information Services Concept to Support the Exchange of Newborn Screening Information Office of the Assistant Secretary for Planning and Evaluation U.S. Department of Health and Human Services December 1, 2009 The views expressed in this report are solely those of the authors, and do not necessarily reflect the views of the Department of Health and Human Services.
Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange
Identifying Opportunities To Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange Meeting Summary Andrew Dorfmann and Jessica Nadler 10/15/2009