Week Note 2017-8

Week of: 

September 25, 2017

Rolling into Recommendations and Getting Input: Reduce, Recalibrate, Redesign

In a previous weeknote, we outlined our one-pager that described our recommendations in a quick way. We are now happy to provide more detail to one of our recommendations, and will consistently be updating these weeknotes with the other ones as they become available. Please click here for the Reduce, Recalibrate, and Redesign brochure that we will be taking to stakeholders in order to get partners on board to implement this recommendation.

We all know that too many clinical trials fail at different stages of the treatment assessment process.

These failures lead to both financial and human cost, among a number of other issues including delayed treatments, clogging of the regulatory pipeline, and an uncertain market.

 

So we built a machine learning model to help identify the items in trial protocol associated with this failure, so we could identify early which trials would fail. It turned out that the number of endpoints and amount of eligibility criteria were among the strongest associated with trial failure.

Both of these findings reflect many conversations we have had with stakeholders and experts- more complex trial design often lead to failure. There is a vicious cycle in treatment development: when a disease or molecule is less well-understood, the clinical trial protocol grows in complexity. In other words when there is more uncertainty, there are more eligibility criteria and more endpoints to manage that lack of understanding. But our analysis, as well as the findings of other researchers, indicates that this strategy leads to failure. Identifying these trials earlier in the treatment development cycle by using models like ours during the facilitated review process can provide more information to sponsors facing difficult decisions about whether these higher risk trials should be modified or halted. We will now take this to the pharmacuetical companies and government regulators and devise a pathway that this recommendation can be implemented.

 

Week Notes Authors

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. 

 

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.

Enrique Martinez
Muchieast, Rhode Island School of Design

Systems Innovation Design Lead

Enrique is the systems innovation and design lead for the project. He is the founder and director of Muchieast LLC, an international consultancy working at the intersection of social, cultural and urban contemporary practices by incorporating the principles of systems innovation and creative thinking. He is a Visiting Lecturer at Brown University and a Senior Critic at the Rhode Island School of Design. Enrique holds a Master in Architecture from the Universidad Politécnica de Madrid, Escuela Técnica Superior de Arquitectura de Madrid; and a Master in Industrial Design, with Honors, from the Rhode Island School of Design, where he was granted the Norman Bel Geddes award in 1998.

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.