Clinical Trials

To understand the size and impact of costs to clinical trial participants, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) conducted an exploratory survey of 112 U.S. adults who participated in an oncology clinical trial between 2018-2024.

The ASPE issue brief examines the research and development cost and duration associated with bringing novel vaccines to the U.S. market. The results indicate that bringing a novel vaccine to the U.S. market costs an estimated $886.8 million on average, and its development process lasts 10 years.

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.

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).

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.

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

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

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.

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.