In some cases, achieving our strategic goals and objectives may be impeded by factors that are beyond the control of the Department of Health and Human Services (HHS). For example, national or local economic conditions can influence whether we are successful in helping families on welfare become economically independent. In some cases, there may b
European Union Restreint ECO 291 CODEC 92 Common Position (EC) No /95 Adopted by the Council on 20 February 1995 With a View to Adopting Directive 94/ /EC of the European Parliament and of the Council on the Protection of Individuals With Regard to the Processing of Personal Data And on the Free Movement of Such Data On the
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In order to use information in EHRs for research, it is first necessary for a number of technical conditions to be in place, such as the ability to extract and format data for research, as well as to address issues with missing data and data quality. As with claims data, the information in EHRs was not collected for research purposes.
Analysis and Proposed Actions Regarding the NBAC Report: Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity
This document presents the findings and proposals of a multi-agency Working Group (WG) convened by the Office of Science Policy, Office of the Assistant Secretary for Planning and Evaluation to develop a proposed response by the Department of Health and Human Services (HHS) to the National Bioethics Advisory Commission (NBAC) Report entitled Rese
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The Office of Public Health and Science (OPHS) provides leadership to the nation on public health and science, and communicates on these subjects to the American people. OPHS is led by the Assistant Secretary for Health (ASH), whose chief interest is promoting, protecting, and improving the nation's health. This role encompasses responsibilities a
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"Quality" is an encompassing term comprising utility, objectivity, and Integrity. Therefore, the Guidelines sometimes refer to these four statutory terms, collectively, as "quality."
HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public
This site describes the HHS Information Quality Guidelines as well as the supporting administrative mechanisms to request correction of information covered under the guidelines. The HHS Guidelines were developed in accordance with the provisions of P.L. 106-554 and OMB government-wide requirements directing all federal agencies to issue guidelines
Examination of Clinical Trial Costs and Barriers for Drug Development. 4.9 Barriers Related to the Globalization of Clinical Research
Another significant barrier to conducting clinical trials in the United States is competition from sites in other countries; indeed, the clinical research footprint is shifting overseas. The number of active, FDA-regulated investigators based outside the United States has grown by 15 percent each year since 2002, while the number of U.S.-based inv
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In addition to the federal regulations listed above, there are also state and local regulations to comply with, and the requirements may be different for each location in multi-site trials. Companies conducting trials at sites in the European Union (EU) (or other countries) are also regulated by the European Commission/EU Clinical Trials Directive
Examination of Clinical Trial Costs and Barriers for Drug Development. 2.1.1 Publically Available Literature
Although the literature on the early stages of the pharmaceutical decision-making process is not extensive, there is some research that has characterized the process. We used this information to help define the components of the model. Some examples are the work performed at the Massachusetts Institute of Technology (MIT) Center for Biomedical Inn
About NIAID . (2012, February 29). Retrieved November 12, 2012, from National Institute of Allergy and Infectious Diseases: http://www.niaid.nih.gov/about/pages/default.aspx Aldy, J. E., & Viscusi, W. K. (2008). Adjusting the Value of a Statistical Life for Age and Cohort Effects. The Review of Economics and Statistics, 90 (3), 573–581
We find that four of the six studied classes (CABP, ABSSI, CUTI and CIAI) had positive ENPVs for developers considering whether to enter the pre-clinical phase of development. However, in all six classes private value fell below the $100 million threshold identified by industry and other experts as the ENPV threshold commonly used in decisions w
Analytical Framework for Examining the Value of Antibacterial Products. 3.4 Threshold Analysis of Incentive Options
We considered each incentive identified in Section 2 in the context of our private ENPV framework. This threshold analysis involved calculating the level of each incentive (in dollars) that would equate the private ENPV to $100 million for a drug sponsor that is at the start of pre-clinical phase. This threshold represents the developer’s op
Analytical Framework for Examining the Value of Antibacterial Products. 2.1.1 Intellectual Property (IP) Protection Extensions
We use the term “intellectual property (IP) protection extensions” to encompass patent/data exclusivity (DE), marketing exclusivity (ME), patent term adjustments (PTAs), patent term extensions (PTEs), and supplementary protection certificates (SPCs); all of which serve to increase drug developer revenues and hence private NPV, by barring gener
Analytical Framework for Examining the Value of Antibacterial Products. 2 Incentives for Developing Antibacterial Drugs, Vaccines for Bacterial Diseases, and Rapid Diagnostics
The literature is replete with possible incentives to stimulate new antibacterial product development. Additionally, the recently enacted Title VIII (Generating Antibiotic Incentives Now) of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144)(GAIN), creates incentives to encourage the development of antibacterial or a
There are two primary objectives to this study: 1) the creation of an economic framework for antibacterial drug development decisions and 2) the assessment of the impact of various incentives on their development. As secondary objectives, this study creates a similar framework for the development of vaccines and rapid point of care diagnostics a
Antibacterial resistance is a growing global problem. According to the most recent statistics from the Centers for Disease Control and Prevention (CDC), at least 2 million people acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat those infections in the United States alone. Of th
Performance Improvement 2013-2014. How Can the Human Research Protections Program at the National Institutes of Health be Enhanced?
The Human Research Protections Program was established to ensure the protection of human subjects who participate in research conducted by the NIH's institutes and centers (ICs). A study was undertaken to identify appropriate infrastructure changes needed to support goals leading to a more centralized and stronger program. The study revealed som
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In 2006, National Institutes of Health (NIH) adopted new standards established by the Association for the Accreditation of Human Subjects Protection Programs to maintain its compliance with policies, laws, and regulations related to human subjects' research. This study assessed the extent to which the NIH-wide Human Research Protection Program (H