Stanford University
Yale University
Pain Management Collaborative is comprised of 12 pragmatic clinical trials that are studying nonpharmacological approaches for the management of pain and common co-occurring conditions in Military and Veterans healthcare systems and are supported by a central Coordinating Center (PMC3).
The lead funding organizations of the PMC and PMC3 include the National Institutes of Health (NIH) (led by the National Center for Complementary and Integrative Health (NCCIH), plus 7 additional offices) the Department of Defense (DOD), and the Department of Veterans Affairs (VA).
Stanford - Digital Education
The Stanford Internet Observatory Turns Three
Stanford Partners Digital Education
How Academic Medicine is Addressing the Opioid Epidemic
Association of American Universities
A Coalition of major US research universities established in 2014 to lobby for the removal of hundreds of federal regulations related to clinical research.
The bureaucratic experiment has slashed by 90% the number of forms used to track key spending, dramatically reduced the amount of time researchers spend doing the paperwork, and nearly eliminated tardy filings, they say. But none of the organs vital to maintaining accountability and transparency appear to have been harmed, they add.
The experiment is part of a larger national effort by U.S. universities to revamp what they argue are costly and wasteful regulations. The rules, whether to protect human patients and research animals or prevent financial conflicts of interest, are often well-intentioned, academic officials say. And sometimes they are a reaction to an egregious breach. But "[t]oo often federal requirements are ill-conceived, ineffective, and/or duplicative," a coalition of major U.S. research universities declared earlier this year. "[T]he time researchers must devote to compliance ... unnecessarily reduces the time they can devote to discovery and innovation," they warned.
Going the Distance: Insights into Rare Disease Clinical Studies, Trial Retention & Patient Experience
Human Centered Artificial Intelligence
Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches
Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.
Agenda
Speakers Biographies
Slide Deck - Presentation
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk
Clinical Investigations - Stanford University Letter to Regulations.gov Docket
RESEARCH
Defense Advanced Research Projects Agency
Defense Advanced Research Projects Agency (DARPA) explicitly reaches for transformational change instead of incremental advances. But it does not perform its engineering alchemy in isolation. It works within an innovation ecosystem that includes academic, corporate and governmental partners, with a constant focus on the Nation’s military Services, which work with DARPA to create new strategic opportunities and novel tactical options. For decades, this vibrant, interlocking ecosystem of diverse collaborators has proven to be a nurturing environment for the intense creativity that DARPA is designed to cultivate.
DARPA comprises approximately 220 government employees in six technical offices, including nearly 100 program managers, who together oversee about 250 research and development programs.
Patient Centered Outcomes Research Institute
Compilation of Excerpted US Code Sections Concerning Patient-Centered Outcomes Research and the Authorization of the Patient-Centered Outcomes Research Institute (PCORI)
Congressionally Directed Medical Research Programs
Chronic Pain Management Research Program
The CPMPR supports and promotes innovative, high-impact research to prevent the development and improve the management of chronic pain. Central to the strategic planning of the CPMRP are the 2016 National Pain Strategy and 2017 Federal Pain Research Strategy of the Interagency Pain Research Coordinating Committee, with elements of the chronic pain and cross-cutting research priorities emphasized in all offered funding opportunities. The CPMRP supports a broad spectrum of research into pain caused by, but not limited to: combat- and training-related physical or mental stress and trauma, migraines and chronic headaches, traumatic brain injury, arthritis, muscular-skeletal conditions, neurological disease, tick and vector-borne disease, other insect-transmitted or tropical disease, and cancer. Currently, the CPMPR has prioritized research in the following strategic areas:
Development of non-opioid therapies and methods for the treatment of chronic pain
Chronification of Pain
Effectiveness and observational studies of novel or untested techniques/approaches/pathways to chronic pain management
Implementation Science (for evidence based, efficacious interventions to manage or prevent chronic pain) Comparative Effectiveness (for evidence based, efficacious interventions to manage or prevent chronic pain)
Observational studies related to chronic pain:
Development Health care use patterns
Treatment outcomes from long-term opioid use
Relationship with comorbidities
Centers of Excellence in Pain Education
The Centers of Excellence in Pain Education (CoEPEs) act as hubs for the development, evaluation, and
distribution of pain management curriculum resources for medical, dental, nursing, pharmacy and other schools to enhance and improve how health care professionals are taught about pain and its treatment. The new CoEPEs were selected by the NIH Pain Consortium after a contract solicitation process and review.
University of Alabama at Birmingham University of California, San Francisco Harvard University
University of Connecticut
University of Iowa
Johns Hopkins University
University of Pennsylvania
University of Pittsburgh
University of Rochester
Southern Illinois University Edwardsville University of Washington
IMMPACT
The mission of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) is to develop consensus reviews and recommendations for improving the design, execution, and interpretation of clinical trials of treatments for pain.
The first IMMPACT meeting was held in November 2002, and there have been a total of twenty-five consensus meetings on clinical trials of treatments for acute and chronic pain in adults and children. Invited participants come from academia, regulatory agencies (US Food and Drug Administration, European Medicines Agency), US National Institutes of Health, US Veterans Administration, consumer support and advocacy groups, and industry.
IMMPACT recommendations and systematic reviews have been widely cited and have guided the design of clinical trials, other types of clinical research, and a national survey. Additional consensus meetings are planned, and research initiatives involving the assessment of pain and the design and interpretation of clinical trials are ongoing. IMMPACT comprises of a group of stakeholders, who believe that this multidisciplinary initiative has made significant contributions to improved understanding of pain and its treatment.
ACTTION
Project Description
ACTTION, a public-private partnership between the University of Rochester (one of the Centers of Excellence for Pain Education)and FDA, will transform, harmonize, merge, and pool raw patient-level data in FDA’s Document Archiving, Reporting & Regulatory Tracking System (DARRTS) from phase 2 and 3 acute and chronic pain trials. Using both patient-level and pooled raw data, the investigators are analyzing patient and study design factors associated with assay sensitivity and placebo group response. Statistical issues and the responsiveness of existing primary and secondary outcomes will also be evaluated. Moreover, ACTTION will assess methods for determining the clinical importance of analgesic trial outcomes, including responder analyses.
Project Goals
To augment FDA’s understanding ofthe relationships between assay sensitivity and metrics, including specific research designs and methodological features, helping to develop an evidence-based approach for designing analgesic clinical trials.
The knowledge gained from the proposed studies has the potential to expand the availability of new analgesic medications that are safe and effective and have fewer side effects.
Patient Centered Outcomes Research Institute (PCORI)
Compilation of Excerpted US Code Sections Concerning Patient-Centered Outcomes Research and the Authorization of the Patient-Centered Outcomes Research Institute
Webinar: Priorities on the Health Horizon: Informing PCORI's Strategic Plan Horizon Scanning Database
The Research Acceleration and Innovation Network (TRAIN)
Clinical Trial Transformation Initiative (CTTI)
Pain Management Collaboratory
Pain Management Collaboratory is comprised of 12 pragmatic clinical trials that are studying nonpharmacological approaches for the management of pain and common co-occurring conditions in Military and Veterans healthcare systems and are supported by a central Coordinating Center (PMC3). The lead funding organizations of the PMC and PMC3 include the National Institutes of Health (NIH) (led by the National Center for Complementary and Integrative Health (NCCIH), plus 7 additional offices) the Department of Defense (DOD), and the Department of Veterans Affairs (VA).