Clinical research forms the foundation for understanding and developing treatments for all types of medical conditions, but participants often do not reflect the diversity of the nation – in terms of sex, age, race, ethnicity, disability status, gender identity, socioeconomic status, geography, or other characteristics.
Biomedical Research & Development
Reports
Displaying 1 - 10 of 11. 10 per page. Page 1.
Advanced SearchASPE Issue Brief
Understanding Markets for Antimicrobial Drugs
Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
Report
Analysis of Market Challenges for Antimicrobial Drug Development in the United States
The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.
Report
Antimicrobial Drugs - Market Returns Analysis
In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance.
Report
National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Fiscal Year 2021
Pathogens that have evolved to be resistant to the drugs currently used to treat infections are an ongoing threat to public health, animal health, food production, and national security. Globally, a recent analysis estimated that 1.2 million deaths were caused by antibiotic-resistant (AR) bacteria in 2019, making this threat a leading cause of death for people of all ages worldwide.
ASPE Issue Brief
FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.
Therapeutic Complex Medical Device Development
This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.
Report
Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development
This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages.
Report
Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes
The objective of this report is to assess the current landscape of federal and federally funded health care data relevant to PCOR and economic analysis to identify gaps for data stewards, researchers, and future collection efforts.
Cost Drivers in the Development and Validation of Biomarkers Used in Drug Development
Despite the increasing investment and interest in drug development, the amount of time and resources needed to develop a new drug continues to rise. Biomarkers are an important tool with the potential to decrease the time, cost, and failure rate of drug development.