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Large Simple Trials and Knowledge Generation in a Learning Health System - Workshop Summary (Paperback, New)
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Large Simple Trials and Knowledge Generation in a Learning Health System - Workshop Summary (Paperback, New)
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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 & Science-Driven
Health Care and the Forum on Drug Discovery, Development, and
Translation. Experts from a wide range of disciplines-including
health information technology, research funding, clinical research
methods, statistics, patients, product development, medical product
regulation, and clinical outcomes research-met to marshal a better
understanding of the issues, options, and approaches to
accelerating the use of LSTs. This publication summarizes
discussions on the potential of LSTs to improve the speed and
practicality of knowledge generation for medical decision making
and medical product development, including efficacy and
effectiveness assessments, in a continuously learning health
system. Large Simple Trials and Knowledge Generation in a Learning
Health System explores acceleration of the use of LSTs to improve
the speed and practicality of knowledge generation for medical
decision making and medical product development; considers the
concepts of LST design, examples of successful LSTs, the relative
advantages of LSTs, and the infrastructure needed to build LST
capacity as a routine function of care; identifies structural,
cultural, and regulatory barriers hindering the development of an
enhanced LST 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. Table of Contents Front Matter 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
General
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