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 project included an environmental scan of the peer-reviewed and gray literature from 2020 to 2023 as well as a series of interviews with experts in clinical trial design, clinical trial operations, decentralized clinical trials, digital health technologies, clinical trial diversity, and regulatory oversight and evaluation. The methods and results from this project are described in detail in the report.
Accompanying the report, an ASPE commentary provides a summary of some of the key lessons learned in the context of two domains: 1) preparing for and conducting clinical trials during a pandemic; and 2) strategies to streamline the everyday conduct of clinical trials.
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