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1 Introduction
Pages 1-4

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From page 1...
... At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. 1 This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers.
From page 2...
... • The following core themes in framing a 2030 agenda: o Diversity and inclusion of clinical trial participants o Convergence of clinical research and clinical practice o Clinical trial data sharing o Incorporation of new technologies into drug research and development o Workforce and career development o Public engagement and partnership o Regulatory environment o Cultural and financial incentives • Key priority challenges and opportunities when it comes to the 2030 clini cal trials enterprise. • Practical short- and long-term goals for improving the efficiency, effective ness, person-centeredness, inclusivity, and integration with health care of the clinical trials enterprise.
From page 3...
... Participants were also able to submit comments and questions throughout the workshop via the webcast comment window or within a dedicated Slack workspace. Chapter 2 provides an overview of some changes in communities and clinical research as a result of the COVID-19 pandemic, lessons learned from the positive and negative effects of those changes, and ways in which an envisioned 2030 clinical trials enterprise could differ from the current system.
From page 4...
... Over the course of the workshop, three current and former FDA officials shared their personal perspectives on the state of the clinical trials enterprise, changes made as a result of the COVID-19 pandemic, examples of positive changes made that potentially could be continued post-pandemic, and what it may take to realize the 2030 vision. These discussions are summarized in Chapter 6, which also includes closing remarks from the workshop co-chairs.

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