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Biomedical Research Policy

Reports

Displaying 1 - 8 of 8. 10 per page. Page 1.

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ASPE Issue Brief

Participant Diversity by Race, Ethnicity, and Sex in Rare Disease Clinical Trials: A Case Study of Eight Rare Cancers

Rare cancer clinical trials appear to enroll less diverse participants than clinical trials more broadly and therefore may require additional considerations or unique solutions to diversify participant recruitment. These differences persisted within both NIH and non-NIH funded trials.
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.

Personalized Health Care Expert Panel Meeting: Summary Report

Contents Demonstrating Clinical Validity and Utility Demonstrating Value Reducing Health Disparities Educating and Engaging Providers and Consumers Using Databases to Build Eviden

Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'

Cover letterHarold Shapiro, Ph.D., Chair National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700 MSC 7979 Bethesda, Maryland 20892-7979 Dear Dr. Shapiro: