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Large Simple Trials and Knowledge Generation in a Learning Health System Workshop Summary (2013) / Chapter Skim
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Appendix A: Workshop Agenda
Pages 65-76

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From page 65...
... to improve the speed and practicality of knowledge generation for medical decision making and medical product development; 2. Consider 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; 3.
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From page 66...
... 2. How would these trials fit into the larger clinical re search ecosystem in a learning health care system?
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From page 67...
... o rial assessing role of waiving medication copayments T for improving drug adherence and health outcomes, collaboration with health insurance company (Aetna) § ost-Myocardial Infarction Free Rx Event and P  Economic Evaluation (MI FREEE)
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From page 68...
... Session Objectives: Ø o Identify stakeholders relevant to the increased use of LSTs, focusing on patients, clinicians/health care systems, and payers, and the incentives that they face that could impede or advance uptake.
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From page 69...
... providing funding for LSTs in routine care settings? Q&A and Open Discussion 4:30 pm Summary and Preview of Next Day 5:00 pm Adjourn Tuesday, November 27 8:00 am Coffee and light breakfast available 8:30 am Welcome, Brief Agenda Overview Welcome, framing of the meeting, and agenda overview o  avid L
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From page 70...
... o  iscuss establishment and sustainability of trial D networks as an infrastructure to host and facilitate LSTs. Presentations: Ø o  ligning care and research to reduce burdens and A improve integration Richard Platt (Harvard Pilgrim Health Care Institute)
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From page 71...
... Califf (Duke University) o thical issues of bringing research and care closer E together Ruth R
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From page 72...
... Q&A and Open Discussion 12:00 pm Lunch Keynote  Randomized Evaluations of Accepted Choices in Treatment (REACT) trials  Tjeerd-Pieter van Staa (Clinical Practice Research Datalink, United Kingdom)
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From page 73...
... Session Questions: Ø 1. In general, what is the optimal role of LSTs in the medical products regulatory approval pathway?
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From page 74...
... Ø rief Summaries and Key Stakeholder Perspectives from B  the Workshop: o  epresentatives from key stakeholders groups R will provide an overview of key themes and issues identified from their perspectives. § ederal funders -- Michael S
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From page 75...
... For example, as the lead of the Ethics and Processes section, can you identify critical needs in infrastructure or regulatory issues that need to be resolved before you can achieve your goals?
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Key Terms

  • simple trials
  • planning committee
  • regulatory issues
  • medical product
  • routine care

  • lst capacity
  • clinical trials
  • pilgrim health
  • care closer
  • clinical data

  • enhanced lst
  • medical products
  • regulatory approval
  • bringing research
  • care settings

  • reusable research
  • institutional review
  • wisconsin school
  • key themes
  • agenda overview

  • research networks
  • harvard pilgrim
  • medical decision
  • lected clinical
  • key stakeholder

  • build lst
  • regulatory barriers
  • product regulatory
  • larger clinical
  • trials fit


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