Artificial Intelligence: the Key to Unlocking Novel Real-World Data?
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Artificial Intelligence in Health Care: the Hope, the Hype, the Promise, the Peril
Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril Michael Matheny, Sonoo Thadaney Israni, Mahnoor Ahmed, and Danielle Whicher, Editors WASHINGTON, DC NAM.EDU PREPUBLICATION COPY - Uncorrected Proofs NATIONAL ACADEMY OF MEDICINE • 500 Fifth Street, NW • WASHINGTON, DC 20001 NOTICE: This publication has undergone peer review according to procedures established by the National Academy of Medicine (NAM). Publication by the NAM worthy of public attention, but does not constitute endorsement of conclusions and recommendationssignifies that it is the by productthe NAM. of The a carefully views presented considered in processthis publication and is a contributionare those of individual contributors and do not represent formal consensus positions of the authors’ organizations; the NAM; or the National Academies of Sciences, Engineering, and Medicine. Library of Congress Cataloging-in-Publication Data to Come Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: Matheny, M., S. Thadaney Israni, M. Ahmed, and D. Whicher, Editors. 2019. Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril. NAM Special Publication. Washington, DC: National Academy of Medicine. PREPUBLICATION COPY - Uncorrected Proofs “Knowing is not enough; we must apply. Willing is not enough; we must do.” --GOETHE PREPUBLICATION COPY - Uncorrected Proofs ABOUT THE NATIONAL ACADEMY OF MEDICINE The National Academy of Medicine is one of three Academies constituting the Nation- al Academies of Sciences, Engineering, and Medicine (the National Academies). The Na- tional Academies provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. -
In an Ehr World
10.5 IDEAS TO THRIVE IN AN EHR WORLD PUBLISHED BY “The future is already here - it’s just not evenly distributed.” William Gibson (in 1993) INTRODUCTION: Most of our industry’s attention thus far has gone towards implementing electronic health record systems (EHRs). While it seems to be end in itself, rolling out an EHR is one of the many building blocks towards a digital platform that can change how healthcare is delivered. This paper gives 10.5 ideas that can help doctors, clinicians and administrators save time and therefore money in an EHR world. These ideas exist as early signals in our industry. It’s only a matter of time when these signals amplify to become an accepted norm. ABOUT THE AUTHOR: Praveen Suthrum, (Twitter: @suthrum) Praveen Suthrum is the President and Co-founder of NextServices, a healthcare management and technology company. He works on product design and technology. He contributed to The New Age of Innovation (by C.K. Prahalad and M.S. Krishnan) that was named the best book on innovation by The Economist in 2008. He has an MBA from The Ross School of Business at University of Michigan and attended Singularity University. Praveen loves to trek and has most recently climbed Mt. Kilimanjaro. 1 Get your records through a mobile cloud. Look at patients, not a computer. Your bank account, trading account, email, family pictures are all on the cloud - you can even access them through your iPad. More than the money required to keep servers running, taking back-ups and engaging IT staff, server-based systems waste time that can be spent elsewhere. -
Using Real World Data in Pharmacoeconomic Evaluations
Using Real World Data in Pharmacoeconomic Evaluations: Challenges, Opportunities, and Approaches Andreas M. Pleil, PhD Senior Director Worldwide Medical and Outcomes Research Pfizer, Inc., La Jolla, CA Slide:2 Disclaimer and Acknowledgements The opinions expressed by the presenter are his and may not reflect the opinions or position of Pfizer, Inc., it’s Board or Management Many thanks to Lou Garrison for allowing me to steal many of these slides shamelessly Slide:3 Today’s Agenda Overview of the Landscape Where do data come from Report from the Task Force What was their charge Who did the charging What did they conclude Discussion points Is the RWTF sufficient Are there gaps in our knowledge What should we do next Applications from your world Group Project Slide:4 Where do “Data” Come From? Pre-clinical studies Provides a first assessment of the expected safety and efficacy of a compound using proven animal models Early Phase Clinical trials IND Safety focus and the beginnings of efficacy, dose ranging, and tolerability Pivotal Clinical trials Demonstrate safety and efficacy in well controlled (generally masked) randomized studies sufficient for market authorization NDA Filed Phase IIIB Expanded trials in different use situations NDA Approved or populations Phase IV Post marketing safety or “new” indications Real World Data Evaluations of safety, effectiveness and outcomes in “routine” clinical practice Slide:5 Who uses “Data”? Companies making internal decision regarding drug development Regulators responsible -
Generating Real-World Evidence by Strengthening Real-World Data Sources
Generating Real-World Evidence by Strengthening Real-World Data Sources Using “real-world evidence” to bring new “Every day, health care professionals are updating patients’ treatments to patients as part of the 21st electronic health records with data on clinical outcomes Century Cures Act (the “Cures Act”) is a key resulting from medical interventions used in routine clinical priority for the Department of Health and practice. As our experience with new medical products Human Services (HHS). Specifically, the Cures expands, our knowledge about how to best maximize their Act places focus on the use of real-world data benefits and minimize potential risks sharpens with each data to support regulatory decision-making, including point we gather. Every clinical use of a product produces data the approval of new indications for existing that can help better inform us about its safety and efficacy.” drugs in order to make drug development faster jacqueline corrigan-curay, md, jd and more efficient. As such, the Cures Act director of the office of medical policy in fda’s center for drug evaluation and research has tasked the Food and Drug Administration (FDA) to develop a framework and guidance for evaluating real-world evidence in the context of drug regulation.1 Under the FDA’s framework, real-world evidence (RWE) is generated by different study designs or analyses, including but not limited to, randomized trials like large simple trials, pragmatic trials, and observational studies. RWE is the clinical evidence about the use, potential benefits, and potential risks of a medical product based on an analysis of real-world data (RWD). -
Using Real-World Evidence to Accelerate Safe and Effective Cures Advancing Medical Innovation for a Healthier America June 2016 Leadership Senator William H
Using Real-World Evidence to Accelerate Safe and Effective Cures Advancing Medical Innovation for a Healthier America June 2016 Leadership Senator William H. Frist, MD Former U.S. Senate Majority Leader Chair, FDA: Advancing Medical Innovation Bipartisan Policy Center Representative Bart Gordon Former Member, U.S. House of Representatives Chair, FDA: Advancing Medical Innovation Bipartisan Policy Center Advisory Committee Marc M. Boutin, JD Chief Executive Officer National Health Council Mark McClellan, MD, PhD Director, Robert J. Margolis Center for Health Policy Duke University Patrick Soon-Shiong, MD Chairman and Chief Executive Officer Institute for Advanced Health Andrew von Eschenbach, MD President Samaritan Health Initiatives 1 Sta G. William Hoagland Ann Gordon Senior Vice President Writer Bipartisan Policy Center Michael Ibara, PharmD Janet M. Marchibroda Independent Consultant Director, Health Innovation Initiative and Executive Director, CEO Council on Health and Innovation Bipartisan Policy Center Tim Swope Senior Policy Analyst Bipartisan Policy Center Sam Watters Administrative Assistant Bipartisan Policy Center 2 FDA: ADVANCING MEDICAL INNOVATION EFFORT The Bipartisan Policy Center’s initiative, FDA: Advancing Medical Innovation, is developing viable policy options to advance medical innovation and reduce the time and cost associated with the discovery, development, and delivery of safe and effective drugs and devices for patients in the United States. Key areas of focus include the following: Improving the medical product development process; Increasing regulatory clarity; Strengthening the Food and Drug Administration’s (FDA) ability to carry out its mission; Using information technology to improve health and health care; and Increasing investment in medical products to address unmet and public health needs. -
Ontario Biology Day 2014 Abstracts
Ontario Biology Day 2014 University of Toronto Mississauga March 22-23, 2014 Abstracts We would like to thank our sponsors Titanium Sponsor Platinum Sponsors Office of the VP Research, UTM Office of the Dean University of Toronto Mississauga Fluid Surveys 2 Gold Sponsors Canadian Society of Zoologists 3 Ontario Biology Day 2014 March 22-23 University of Toronto Mississauga Conference Organizing Committee Daniel Almeida Lisa Cheung Yen Du Sanja Hinic-Frlog Aaron LeBlanc Fiona Rawle Audrey Reid Christoph Richter Published by: University of Toronto Mississauga Department of Biology 3359 Mississauga Road Mississauga, ON L5L 1C6 http://www.utm.utoronto.ca/biology Twitter: @UTMBiology Copyright 2014 Logo Design by Scott Winrow 4 Welcome to Ontario Biology Day 2014 at the University of Toronto Mississauga! We are thrilled to welcome you to the 27th annual Ontario sponsors by signing the “Thank you to our sponsors” card at the Biology Day (OBD) undergraduate student research conference. registration desk. And importantly, we would like to extend a On behalf of the Department of Biology at the University of thank you to all of the supervisors and students that have Toronto Mississauga, we wish you the best of success in travelled to the conference this weekend to present their work presenting your research to your peers this weekend, and and share in this conference experience. This conference is a congratulate you on your achievement in undergraduate biology celebration of your research, and we congratulate you on your research. hard work and research achievements. OBD is an annual event that showcases and celebrates biology Sincerely, research conducted by undergraduate students across Ontario. -
Korea Sukyeong Kim, Phd Senior Research Fellow, International Cooperation Advisor Evidence-Based Healthcare Research Division
Real World Evidence and Local Evidence Generation: How Should it Be Approached in Asia Pacific? - Korea Sukyeong Kim, PhD Senior Research Fellow, International Cooperation Advisor Evidence-based Healthcare Research Division Real World Data & Real World Evidence • Real World Data o The data relating to patient health status and/ or the delivery of health care routinely collected from a variety of sources • Electronic health records (EHRs) • Claims and billing activities • Product and disease registries • Patient-related activities in out-patient or in-home use settings • Health-monitoring devices • Real World Evidence o The clinical evidence regarding the usage and potential benefits or risks of medical product derived from analysis of Real World Data FDA. Real World Evidence. https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm 2 1 NHI system and Real World Data • National Health Insurance System o Operating based on Electronic Data Interchange and web-base claims submission 3 Real World Data • Medical Record o Electronic Medical Record in Hospitals and Clinics • Facilitated by electronic National Health Insurance Claims Review and Assessment system building • Tertiary hospitals have been leading Electronic Medical Record and hospital Information and Communication System • Medium and small hospitals and clinics adopted EMR system around 97% in 2014 4 2 Real World Data • National Health Insurance Information System o Electronic NHI Claims Review and Assessment System • Based on web-based claims submission 5 Real -
Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics July 2019 LEADERSHIP William H
Expanding the Use of Real- World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics July 2019 LEADERSHIP William H. Frist, M.D. Mark McClellan, M.D., Ph.D. Former U.S. Senate Majority Leader Robert J. Margolis Professor of Business, Medicine, Senior Fellow, Bipartisan Policy Center and Policy, Duke University Founding Director, Duke-Margolis Center for Robert Califf, M.D., Ph.D. Health Policy Professor of Medicine, Donald F. Fortin, M.D., Former Administrator, Centers for Medicare and Professor of Cardiology, Duke School of Medicine Medicaid Services Member, Duke Clinical Research Institute Former Commissioner, Food and Drug Administration Former Commissioner, Food and Drug Administration Andrew von Eschenbach, M.D. President, Samaritan Health Initiatives Former Commissioner, Food and Drug Administration Former Director, National Cancer Institute Senior Fellow, Bipartisan Policy Center STAFF G. William Hoagland Janet M. Marchibroda Senior Vice President Fellow, Bipartisan Policy Center CONSULTANTS Gregory Daniel, Ph.D., R.Ph. Morgan Romine Deputy Director, Duke Margolis Center for Research Director, Duke Margolis Center for Health Policy Health Policy Clinical Professor, Fuqua School of Business, Mark Segal, Ph.D., FHIMSS Duke University Principal, Digital Health Policy Advisors ACKNOWLEDGMENTS The Bipartisan Policy Center would like to thank the Jayne Koskinas Ted Giovanis Foundation for Health and Policy for their generous support for this project. BPC would like to thank the leadership of this effort, including Senator Bill Frist, Dr. Rob Califf, Dr. Mark McClellan, and Dr. Andrew von Eschenbach, for their guidance, as well as Morgan Romine, Gregory Daniel, Mark Segal, and Ann Gordon who contributed to the development of this report. -
Premier Healthcare Database
WHITE PAPER: PREMIER HOSPITAL DATABASE (PHD) – March 2, 2020 Premier Healthcare Database: Data That Informs and Performs Premier Applied Sciences®, the Research Division of Premier Inc. March 2, 2020 This white paper provides a detailed description of the attributes and capabilities of the Premier Healthcare Database (PHD), which has been utilized by the pharmaceutical and device industries, academia, healthcare insurers and healthcare policy makers For clinical, financial and outcomes analyses. Since the year 2000, more than 600 publications in peer- reviewed journals – the gold standard for publishing research – have included more than 110 articles written by Premier stafF in multiple therapeutic and quality improvement/patient safety areas (Premier Applied Sciences® website). Details on data source, type and scope are outlined. Premier Applied Sciences® is the Research Division of Premier Inc. and is responsible For leveraging the HIPAA-compliant PHD through its highly proFessional and experienced team. SUGGESTED CITATION: Premier Healthcare Database White Paper: Data that informs and performs, March 2, 2020. Premier Applied Sciences®, Premier Inc. https://learn.premierinc.com/white-papers/premier-healthcare- database-whitepaper. 1 WHITE PAPER: PREMIER HOSPITAL DATABASE (PHD) – March 2, 2020 INTRODUCTION Electronic healthcare databases house “big data” and offer several advantages as a robust research tool1-3. A comprehensive hospital-based healthcare history of each patient in the healthcare system may be available. Patients and physicians are not involved in data collection, thus eliminating potential bias that may come with being observed. Since data accrues from a large diverse population, rare outcomes and long-term effects can be studied. The data reflects the state of clinical practice in the general population. -
Optimizing Rwe Generation Fda's
appliedclinicaltrialsonline.com Volume 28 Number 4 April 2019 YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL TRIALS MANAGEMENT 1992–2019 ACTAACCT 2727 e Year c of Servi STUDY DESIGN OPTIMIZING RWE GENERATION REGULATORY For personal, non-commercial use FDA’S ‘REAL-WORLD’ FRAMEWORK DATA SHARING ADOPTING GLOBAL DATA STANDARDS WASHINGTON REPORT EU REPORT CLOSING THOUGHT The Push to Broaden Clinical Translational Research Message Rise of the ‘Citizen Trial Eligibility Criteria Lost in Transmission Data Scientist’ FROM THE EDITOR Emerging Biopharma Deserve TLC from CROs arly this month, I presented on the topic was 26%, compared to 60% that went to firms that had never before E“Why Aren’t Lessons Learned from Big received an approval. Pharma/Big CROs Translating to Smaller The days of quickly selling a promising compound early on to a large Biopharma Relationships?” For years, Applied pharma company or launching a full-fledged IPO are dwindling. An Ernst Clinical Trials has been the operational re- & Young report showed 75 biotech IPOs in 2014 compared to nine in the source for clinical trials for sponsors, CROs, second half of 2016. These days, innovation hubs in major regions of the and academia. The transition of the contract country are home to a vast number of companies looking to enter clini- research industry from a small cottage to a cal trials, take their compound at least through Phase II, and some are LISA HENDERSON fully-matured one has seen numerous out- fully intending to stick it through Phase III and even make it to a com- Editor-in-Chief sourcing models from the low-touch, very fo- mercial stage company. -
Programs Director for IT Services Research and Where He Created the Global IT Service Research and Innovation Institute, SRII (
SRII China Summit 2015 Theme: Innovating Digital Economy — Advancing Industry 4.0 Transformation Time: March 4-6, 2015 Venue: Shanghai, China Background Advanced Industrial Technology Research Institute in Shanghai Jiao Tong University(AITRI) is excited to team up with Service Research & Innovation Institute (SRII) to host 2015 SRII China Summit:Innovating Digital Economy— Advancing Industry 4.0 Transformation from March 4th to 6th, 2015 in Shanghai Lingang New City. Senior leaders from key industry sectors, academia, research, government and professional organizations in India, Asia, Europe and USA will be invited to discuss IOT, big data, Industry 4.0, Smart-Healthcare, Education and other related topics. The summit is well aligned with innovation agenda for industry upgrade and emerging market in Shanghai as well as in China. SRII (Service Research & Innovation Institute) is a global ICT Research & Innovation Institute with a mission to drive ICT Innovation (Cloud computing, Mobile Services, Big data analytics, Security, Social) for major sectors of service economy (government, education, healthcare, transportation, manufacturing, agriculture & food safety, and etc) around the world. SRII member include senior leaders from industry, academia, research and government organizations from around the world. Advanced Industrial Research Institute (AITRI) promotes the emerging pillar industries transferred from the high-tech research findings by maximizing the market value of the industrial technologies. AITRI is building an international -
Obituary: Thomas Henry Kunz (1938–2020)
applyparastyle "fig//caption/p[1]" parastyle "FigCapt" applyparastyle "fig" parastyle "Figure" Journal of Mammalogy, 101(6):1752–1780, 2020 DOI:10.1093/jmammal/gyaa100 Published online November 20, 2020 Obituary: Thomas Henry Kunz (1938–2020) Dr. Thomas Henry Kunz (Fig. 1), an internationally rec- Tom’s early interest in science was sparked by a fifth-grade ognized expert on the ecology and behavior of bats and teacher who had her students undertake a project raising silk- Professor at Boston University, passed away on 13 April 2020 worms. Tom commented in his autobiography that, “This ex- in Dedham, Massachusetts, at the age of 81 as the result of perience left an indelible impression on me, and highlights the complications from COVID-19. Tragically, Dr. Kunz’s career power of observational learning” (197:150). Tom also had an was cut short when he was the victim of a pedestrian–auto- early experience with a bat colony inside a stove in a fishing mobile accident on 26 October 2011. He was struck crossing cabin. After chasing and removing the bats from the cabin, a street in Toronto, Canada, while participating in his favorite Tom recalled, “being fascinated by these little winged ‘crit- annual meeting, that of the North American Society for Bat ters’” (197:150). Tom became an Eagle Scout and remembered Research (NASBR). He never fully recovered from the head taking great pride in earning his nature merit badge, which re- trauma suffered and was not able to live independently, but quired learning the names of local plants and animals. When he enjoyed daily visits from his wife and frequent visits from Tom graduated from high school, he was planning to attend his children and grandchildren as well as friends.