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Clinical Trials

Reports

Displaying 1 - 10 of 12. 10 per page. Page 1.

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Report

Drug Development

The cost of bringing a medical product to the U.S. market has been increasing and clinical trials constitute a large portion of these costs. In drug development, the clinical phase lasts an average of around 95 months compared to 31 months for the non-clinical phase and accounts for 69 percent of overall R&D costs (DiMasi, et al., 2016).
Environmental Scan

Impact of COVID-19 on Clinical Trials Costs to Patients

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.
ASPE Issue Brief, Report

Transformation of the Clinical Trial Enterprise: Lessons Learned from the COVID-19 Pandemic

In 2023, ASPE launched a research project to understand the impacts of COVID-19 on the clinical trial enterprise and identify key lessons learned.
Research Summary

Costs of Drug Development and Research and Development Intensity in the US, 2000-2018

This landing page represents the abstract of a paper published in JAMA. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820562.Abstract
ASPE Issue Brief

HHS Actions to Enhance Diversity in Clinical Research

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.

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.
ASPE Issue Brief

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US

This document presents the abstract of this paper, as published in JAMA Network Open. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796179 Related Products:

Examination of Clinical Trial Costs and Barriers for Drug Development

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.