Large Simple Trials and Knowledge Generation in a Learning Health System : Workshop Summary.
Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as l...
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| 520 | 8 | |a Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as large simple trials (LSTs), may provide opportunities for progress on these challenges. Clinical trials support the development of new medical products and the evaluation of existing products by generating knowledge about safety and efficacy in pre- and post-marketing settings and serve to inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers."Large Simple Trials and Knowledge Generation in a Learning Health System" is the summary of a workshop convened by the Institute of Medicine's Roundtable on Value considers the concepts of 1st design, examples of successful LSTs, the relative advantages of LSTs, and the infrastructure needed to build 1st capacity as a routine function of care; identifies structural, cultural, and regulatory barriers hindering the development of an enhanced 1st capacity; discusses needs and strategies in building public demand for and participation in LSTs; and considers near-term strategies for accelerating progress in the uptake of LSTs in the United States. | |
| 521 | |a Scholarly & Professional |b National Academies Press. | ||
| 505 | 0 | |a Front Matter; Reviewers; Preface; Contents; 1 Introduction; 2 Large Simple Trials Now and Looking Forward; 3 Examples of Large Simple Trials; 4 Medical Product Regulatory Issues; 5 Infrastructure Needs and Opportunities; 6 Ethical and Privacy Policy Issues; 7 Research Partner Perspectives; 8 The Randomized Evaluations of Accepted Choices in Treatment Trials; 9 Strategies Going Forward; Appendix A: Workshop Agenda; Appendix B: Biographical Sketches of Speakers | |
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| 700 | 1 | |a English, Rebecca A., |e General Rapporteur. |4 oth | |
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