Biomedical Research & Development

This landing page presents the abstract of a paper published in Health Affairs. The full text of the article is available at: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2023.00837.

This environmental scan, conducted by Mathematica and funded by ASPE, examines the types of direct and direct costs to patients associated with clinical trial participation. It also explores the effect of COVID-19 on costs to patients, including cost implications of clinical trial innovations widely implemented during COVID-19 and other efforts to increase diversity of clinical trials.

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.

Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.

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.

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.

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.

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.

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.

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.