Clinical Trials Process

 

Overview

This project will utilize systems thinking and design principles to identify and map the current clinical trial process, identify breakdowns in the process and develop strategies to address those breakdowns.  By taking a broad view of the system our goal is to identify areas that have not been addressed which will have a major impact on the system as a whole.

We recognize that there are many groups looking deeply into the individual pieces of the clinical trial process and we plan to work with them as we take this broader perspective.  The intent of the project is not to compete with but to augment current work being done.

The project will use the tools that engineers and architects are trained in, to visualize the current system, a potential future state and pathways to get there.  A critical component of this strategy is that we do not enter the project with a hypothesis to test.  We model the current state and work back to identify critical breakdowns, then move forward to address those breakdowns.

Please Follow our weekly project updates and insights on our Week Notes page.

Project Partners

Johns Hopkins University

Sauleh Siddiqui, Co-Research Lead, Director, Center for Systems Science & Engineering, Whiting School of Engineering;   Jen Bernstein, Co-Research Lead, Center for Leadership Education, Whiting School of Engineering    

 

 

 

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Project Advisors

Strategic Advisory Group

Clayton ChristensenPhD

Kim B. Clark Professor of Business Administration, Harvard Business School

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Elazer Edelman, MD, PhD

Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology at MIT; Professor of Medicine at Harvard Medical School; Senior Attending Physician in the coronary care unit at Brigham and Women's Hospital, Boston

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Robert LangerScD

Institute Professor, MIT

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T.E. SchlesingerPhD

Benjamin T. Rome Dean, Professor of Electrical and Computer Engineering, Whiting School of Engineering, Johns Hopkins University

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Lawrence H. SummersPhD

Charles W. Eliot University Professor and President Emeritus at Harvard University; 71st Seretary of the Treasury for President Clinton; Director of the National Economic Council for President Obama

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Maria T. Zuber, PhD

Vice President for Research, MIT

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Expert Advisory Group

Dennis A. AusielloMD

Jackson Distinguished Professor of Clinical Medicine and Director Emeritus, MD/PhD Program, Harvard Medical School; Chairman Emeritus, Department of Medicine and Director, Center for Assessment Technology and Continuous Health (CATCH), Massachusett General Hospital

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Jorge Insuasty, MD

Vice President for R&D, Deputy to the President for Development, Sanofi

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Freda C. Lewis-HallMD

Chief Medical Officer, Pfizer

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Megan McBride, MPH

Associate Director, Clinical Trial Innovation, Janssen Pharmaceutical Companies of J&J

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Alex (Sandy) PentlandPhD

Toshiba Professor of Media Arts and Sciences; Director, Media Lab Entrepreneurship Program, MIT

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Mike PooleMD

Director, Global Health Office of the President, Bill & Melinda Gates Foundation

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Pamela TenaertsMD, MBA

Executive Director, Clinical Trials Transformation Initiative (CTTI), Duke University

 

 

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Deborah A. Zarin, MD

Director, ClinicalTrials.gov, National Library of Medicine

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Project team members

Tenley Albright, MD
MIT Collaborative Initiatives

Strategic Lead

Dr. Albright is the Director of MIT Collaborative Initiatives which promotes a systems based approach to solving deep rooted societal issues by engaging experts from a broad range of disciplines both within and outside the scope of a problem.

Dr. Albright serves on the Board of the Bloomberg Philanthropies, is a Consultant and Advisor to the Military Health System, and is a member of the Center for the Study of the Presidency and Congress and serves on its Board of Counselors.  In addition, she serves on the Board of Research!America, and the Advisory Board of Nanobiosym, Inc.  Dr. Albright has served on the Defense Health Board of the Department of Defense and on the Board of Directors of the Whitehead Institute for Biomedical Research and on the board of West Pharmaceutical Services, a public company investigating new types of drug delivery, where she chaired the Technology Committee and served on the Audit Committee and the Governance Committee and as Board Liaison to its Scientific Advisory Board.  She has served on the Board of State Street Bank and Trust Company and State Street Corporation and on its Audit Committee.  She is also on the Leadership Board at McGovern Institute for Brain Research.

She is a Faculty Member and Lecturer in General Surgery at Harvard Medical School, and formerly a Director of West Pharmaceutical Services, Inc., State Street Bank and Trust Company, and the Whitehead Institute for Biomedical Research. She has also served as delegate to the World Health Assembly for four years and has been inducted into the Military Health System Honor Society.  Dr. Albright is the recipient of the 2011 White House Fellows Valenti Award.

Dr. Albright graduated from Harvard Medical School after attending Radcliffe College and has received eight honorary degrees.  Earlier, she was a Gold Medal Olympic Figure Skater.

Jen Bernstein, MPH
Johns Hopkins University Co-Research Lead

Co-Research Lead

Jen Bernstein has 15 years experience working on WHO-, industry-, U.S. government-funded research studies and clinical trials.  She received her Master of Public Health at the Johns Hopkins Bloomberg School of Public Health and currently works as Part-Time Faculty in the Johns Hopkins Whiting School of Engineering. Jen is also a clinical research associate and independent research consultant providing research support for deliverables at all stages of project development including IRB submissions, journal articles, presentations, and grant submissions. Jen honed her skills at a variety of institutions including The Urban Institute, the Johns Hopkins Center for Communication Programs, and The Weinberg Center for Women's Health and Medicine at Mercy Medical Center. 

Ellie Carlough
MIT Collaborative Initiatives

Ellie Carlough is currently Associate Director of MIT Collaborative Initiatives (MIT-CI) and has been with the organization since September 2007.  In this role, she is actively involved in project management, writing and strategic planning for MIT-CI, which applies a system-based approach to addressing widespread societal issues reaching a crisis point.

Ellie graduated from Mount Holyoke College and earned a Masters of Science in Non-profit Management from the New School for Social Research in New York, New York.  After working in Manhattan for 10 years in banking and most recently as Director of Corporate and Foundation Relations at St. Vincent’s Hospital and Medical Center of New York, Ms. Carlough spent a time in the challenging position of full-time mother mastering the art of multi-tasking and social networking before joining MIT-CI.

Justin Cook
SITRA, MIT Collaborative Initiatives

Based in Boston, Justin is the Finnish Innovation Fund's (Sitra) academic liaison for North America and serves as Sitra's Senior Lead for Sustainable Development. He helped design and build the Low2No urban decarbonization initiative and manage its implementation, and served as Helsinki Design Lab's expert on energy, carbon and sustainability. 

Currently he is helping Sitra better align its endowment with its mission by developing ways to place capital in businesses, projects and funds that generate measurable social and environmental impact together with financial return. As part of Sitra’s Strategic Research team, he works to support and challenge Sitra's strategy and shared assumptions. His research includes developing a more comprehensive understanding of sustainable well-being and how Nordic countries can transition toward it with practical economic and public policy measures.

Justin is also an Adjunct Professor at the Rhode Island School of Design where he teaches graduate level design courses. He holds a Master of Architecture degree from the Harvard Graduate School of Design and a Bachelor of Arts from the University of Washington. Find him @justinwcook.

Vivasvat Dadwal
Johns Hopkins University

Viva Dadwal is a Visiting Scholar at Johns Hopkins University Bloomberg School of Public Health, where she is investigating the transfer of health innovations from low to high-income countries. She is a published academic, a Senior Fellow at the Centre on Governance at the University of Ottawa and a Deputy Editor of open-access global health journal, Globalization and Health. Previously, she worked as a Trade Policy Officer for Foreign Affairs, Trade and Development Canada. Viva has held prestigious internships at the World Health Organization and Permanent Mission of Canada to the United Nations and to the World Trade Organization in Geneva, Switzerland.

In her spare time, Viva promotes public astronomy in urban cities through a project called #popscope. She also guest blogs for World Bank’s youth blog, Youthink! Viva holds a B.Sc. (Hons) in Biology from the University of Windsor and an M.A. in Public and International Affairs from the University of Ottawa. Viva is a recipient of Fulbright Canada Award 2014-2015 and a member of the World Economic Forum Global Shapers community. Follow Viva's adventures on Twitter @vivadadwal.

Francisco Del Canto Viterale, PhD
Johns Hopkins University

Francisco Del Canto Viterale is Postdoctoral Researcher in the Systems Institute within the Whiting School of Engineering at Johns Hopkins University. Currently, he is working on two different research projects: “Complex International Innovation Partnerships”, and “Clinical Trials Systems”.

His core area of expertise is the intersection of Science Technology Innovation and Higher Education, and International Relations.

Francisco has been working in the academia for over seventeen years in several countries. He has an extensive experience working as a university lecturer in International Studies, International Migration and Latin American Studies; and also as a researcher in topics related to International Scientific Relations, Science and Innovation Policy and Interdisciplinary, Complex and Systems Approach.

He received his Ph.D. in International and Intercultural Studies from the University of Deusto (Spain) in January 2014. Prior to his doctorate, he earned a Bachelor of Science in International Relations (1998), a Diplomat in International Affairs and Diplomacy (1999) in Argentina, and a Masters in International Migrations and Social Cohesion (2011) in Spain.

Felipe Feijoo, PhD
Johns Hopkins University

Felipe Feijoo is a Postdoctoral researcher at the Systems Institute in the Whiting School of Engineering, The Johns Hopkins University.

He obtained his B.S. in Engineering Sciences at the Universidad de La Frontera, Chile. Thereafter, he pursued his Master degree (2011) and Ph.D. (2015) in Industrial Engineering at the University of South Florida, Tampa.  

His current research involves the application of stochastic complementarity models and economics to analyze the opening of clinical trials and the pharmaceutical market in the U.S. 

His research also focuses on the application of mathematical programming, game theory, and statistics for decision making in sustainable electricity markets. He worked on a mathematical-statistical framework to developed Pareto designs of cap-and-trade carbon policies with high penetration of green energy via micro-grids. Other research interests include health-economics and predicting-forecast modeling using machine learning techniques. Felipe has also worked and led several projects for the Tampa Electric Company (TECO), Florida.

Tak Igusa,PhD
Johns Hopkins University

Senior Advisor

Dr. Tak Igusa is a professor at the Johns Hopkins University who has been engaged in multi-disciplinary collaborations spanning a wide range of fields.  He currently holds appointments in the Departments of Civil Engineering, International Health, Earth and Planetary Sciences, and Applied Mathematics & Statistics.  To provide rigor to his collaborative activities, Dr. Igusa has been promoting systems science and methodologies, which has led to significant, new research programs within the university.  This includes projects funded by the NIH, Robert Wood Johnson Foundation, CDC and the National Science Foundation on systemic studies of childhood obesity, rheumatic disease, community resilience to natural disasters, and technology innovation in developing nations.  His work led to the establishment of the Johns Hopkins Systems Institute in 2011.

Dr. Igusa received an A.B. in Applied Mathematics from Harvard University and a PhD in Civil Engineering from University of California, Berkeley. At Johns Hopkins, he is currently the Director for Health of the Systems Institute and the Program Lead of the Education & Training Program at the Global Obesity Prevention Center.  He is also advising the development of systems research programs that bridge public health and engineering at the University of the Witwatersrand in Johannesburg, South Africa. 

 

Patty Lauria
MIT Collaborative Initiatives
Gary Lin
Johns Hopkins University

Gary Lin is currently working on complex systems research with the Johns Hopkins Systems Institute and pursuing a Doctor of Philosophy in Civil Engineering at the Johns Hopkins University.  He has a variety of research interests which includes healthcare systems, infrastructure systems, supply chain and transportation networks, and human population dynamics.  Using his diverse background, Gary has been involved in numerous interdisciplinary projects that range from natural gas networks to environmental impacts of population growth.  He hopes to apply the systems approach towards large-scale, health and engineering issues that face present and future society.

Gary obtained his Bachelor of Science in Civil Engineering and Bachelor of Arts in Economics from the University of Colorado at Boulder.  He is also a registered Engineer-in-Training (EIT) in the state of Colorado and student member of the American Society of Civil Engineers.  In addition, Gary has experience working in food transportation logistics, financial administration, and construction marketing.  Gary enjoys disc golfing, cycling, and hiking in his spare time.

Paul A. Locke JD, MPH, DrPH
Johns Hopkins University

Paul Locke, an environmental health scientist and attorney, is an Associate Professor at the Johns Hopkins Bloomberg School of Public Health in the Department of Environmental Health Sciences.  He holds a joint appointment in the Department of Health Policy and Management.  Dr. Locke is also the Distinguished Visiting Professor of Animal Law and Science at the Northwestern School of Law of Lewis & Clark College.   Dr. Locke has an MPH from Yale University School of Medicine, a DrPH from the Johns Hopkins University Bloomberg School of Public Health and a JD degree from Vanderbilt University School of Law. 

At Hopkins, Dr. Locke leads an integrated public health research, practice and teaching program.  His program focuses on research-to-practice initiatives to better protect public health, especially in advancing evidence-based in vitro toxicology and radiation protection policy at federal and international organizations.  He has published widely in both law reviews and scientific and policy journals, and has developed three cross-disciplinary courses in environmental law and policy and animal law.  Dr. Locke also directs the School’s Doctor of Public Health program in Environmental Health Sciences and a certificate program in Humane Sciences and Toxicology Policy.

As a member of the clinical trials initiative team, Dr. Locke is helping to better understand the laws, regulations and policies that frame clinical trials and human subjects research, and seeking opportunities to utilize rapidly evolving in vitro toxicological methodologies and other new techniques in clinical trial decision-making.      

Dr. Locke is admitted to practice law in the state of New York and the District of Columbia, the Southern District Court of New York and is a member of the bar of the United States Supreme Court.

Michele Palopoli
Johns Hopkins University, Bloomberg School of Public Health

Michele is currently a Senior Research Assistant at Johns Hopkins Bloomberg School of Public Health in the Department of Environmental Health Sciences. Her interests include risk management and communication, effective translation of science into policy, and more recently, using a systems approach to fix ineffective or outdated policy. Since obtaining a Master’s in Health Science and a Certificate in Risk Science and Public Policy in 2012, she has been working on communications with congressional offices on Capitol Hill, conducting legislative analysis, producing advocacy materials and organizing consultation meetings with congressional offices.

Sauleh Siddiqui, PhD
Johns Hopkins University Co-Research Lead

Co-Research Lead

Dr. Sauleh Siddiqui is an Assistant Professor of Civil Engineering with an appointment in AppliedMathematics & Statistics at Johns Hopkins University and is affiliated with the Johns Hopkins Systems Institute. He is also a Visiting Researcher and Lecturer at the Technical University of Berlin and the German Economic Research Institute (DIW Berlin). His research is on formulating and solving optimization and game theory models applicable to large-scale systems. Such systems arise when modeling problems in energy and environmental markets, public health, and transportation. He also models engineering design and develops novel algorithms along with supporting mathematical theory.

He has received research funding from the World Bank, Johns Hopkins Health System, the Environment Energy Sustainability Health Institute, and the Norwegian Research Council. In addition, he has collaborated on projects with the International Council on Clean Transportation, Institute of Medicine, National Academy of Engineering, and Bikemore. These projects have included modeling energy and climate markets, patient flow and staffing in hospitals, global vaccination strategies, and urban transport networks.       

He received an A.B. in Mathematics and Public Policy from Franklin & Marshall College and a Ph.D. in Applied Mathematics & Statistics, and Scientific Computation from the University of Maryland, College Park. 

Erin Todaro
Johns Hopkins University

Erin Todaro is an undergraduate student in the Johns Hopkins University class of 2018 who is pursuing her Bachelor of Science in Civil Engineering. This is her first project as a student researcher. Her interests include systems research and public health infrastructure and development.