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Biomedical Research, Science, & Technology

Reports

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ASPE Issue Brief

Measuring Innovation of Medical Products

Increasing innovation in medical products is a policy priority. A first step to understanding changes in the level of innovation is to determine how to measure the baseline of innovation. Existing research employs a variety of measurement methods–scientific, therapeutic, and economic measures–to study trends in medical product (e.g., drugs, biologics, devices) innovation.
Report

Understanding the Role of Patient Advocacy Organizations in Funding Medical Product Research and Development

Patient advocacy organizations (PAOs) play a key role in medical product development. Many PAOs raise money to fund medical product development activities – such as basic science research, preclinical research, and clinical trials - for their condition of focus, whereas others fund or develop resources such as biobanks or patient registries to support the research community.
Report

U.S. Biosimilar Market Entry Challenges and Facilitating Factors

There is ongoing interest in understanding ways to reduce drug prices and improve patient access to prescription drugs in the U.S. The estimated savings to the U.S. healthcare system from the use of biosimilars are significant.
ASPE Issue Brief

Use of Participant Compensation in U.S. Clinical Research Studies

Providing compensation to clinical research participants to offset the costs associated with participation is often suggested as a way to improve recruitment and retention. However, relatively little is known about the landscape of compensation in clinical research.
ASPE Issue Brief

Competition in the U.S. Therapeutic Biologics Market

Spending on biologics—large, complex molecules made from a living source—has been increasing over time and now represents nearly half of all U.S. prescription drug spending. Biosimilar competition for biologics is limited.
ASPE Issue Brief

Empowering Patients to Participate in Clinical Trials

Increasing patient engagement in clinical trials offers opportunities to improve enrollment and retention in clinical trials, helping ensure interventions can be evaluated effectively and that clinical research dollars are used efficiently.
ASPE Issue Brief, Fact Sheet

Health Care and Child Care Costs Contribute to the Unsustainable and Growing Cost of Raising a Family in America

The cost of raising a family in America is high and continues to rise, with inflation rising by 23 percent between 2020 and 2025. For working families, some of the largest nondiscretionary expenses continue to be health care and child care.
ASPE Issue Brief

Understanding the Impact and Costs Associated with Medical Device Shortages During the COVID-19 Pandemic on Providers, Health Systems, Patients, and Manufacturers

We conducted a landscape analysis to understand the characteristics, impacts, and costs associated with medical device shortages during the COVID-19 pandemic in the U.S. Among health systems, nursing homes and rural hospitals were the most impacted by medical device shortages due to high demand and supply transportation issues.
Report

2025-2028 Draft Action Plan for Addressing Shortages of Medical Products and Critical Foods and Strengthening the Resilience of Medical Product and Critical Food Supply Chains

The 2025-2028 Draft Action Plan for Addressing Shortages of Medical Products and Critical Foods and Strengthening the Resilience of Medical Product and Critical Food Supply Chains (“Draft Action Plan”) presents coordinated and strategic actions that the Department of Health and Human Services (“HHS,” or “Department”) plans to take from 2025 through 2028.
ASPE Issue Brief

Financial stress associated with oncology clinical trial participation

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.