Week Note 2015 - 24

Week of: 

September 28, 2015

The Clinical Trials Connection

At the most fundamental level, the world is comprised of objects that interact with other objects.  Objects can be defined as people, locations, molecules, or even ideas.  Movement, communication, and perception can all be considered forms of interaction that occur between objects.  A system is a collection of these objects which behaves in a certain manner that can either be predictable or chaotic.  In order to make this chaos simple, these objects can be represented as a collection of nodes.  A links or arc represents a pathway that can be physical, social, and virtual (e.g. roads, relationships, and clickable hyperlinks, respectively).  It is through these pathways that these interactions will occur.  In certain instances, novel interactions create new arcs, contributing to an ever-changing topology of our networked world.  The interesting aspects of networks are the emergent properties that manifest themselves from the system composed of dynamic interactions that occur between the linkages.  However, one must be able to understand the appropriate context in which networks can provide valid insights.  The intersection between reality and network representation is where complex system and network science becomes relevant.

 

Social networks play a valuable role in the research domain, and I’m not just talking about Facebook.  I’m talking about the relationships or connections between people. Social networks are important since they determine who researchers are communicating and collaborating with.  In these networks, the nodes represent people and the arcs represent the personal or business relationships.  Social networking sites such as LinkedIn have formalized these organic connections through a convenient virtual medium (i.e. your internet browser).  The number of these connections can determine a person’s social capital since they have access to more information and opportunities.  Social network analysis has employed these types of collaborative social networks.

 

My LinkedIn Network – can you find me? (Courtesy of SociLab)

 

In some instances, these social connections provide accessibility to healthcare.  After our visit to the National Kidney Foundations, we received a brief glimpse of their vision to create an online social community in order to facilitate advocacy outreach, as well as provide patient-to-patient mentorship.  This virtual community also serves as a reliable device to recruit and support patients for clinical trials.  Even the Food and Drug Administration (FDA) have suggested that a Match.com-esque platform to help patients find relevant clinical trials for their ailments.  The neat part of social networks is that they can transcend the physical world by becoming virtual.  In other words, it is now possible to meet people without ever seeing them.

 

In this Age of Information, the ability to understand our world lies in our own capacity to perceive the world in networks.  The Internet, an inherently networked entity in itself, has streamlined data collection so dramatically that research can now be conducted remotely via a Wi-Fi or coaxial cable connection.  In the realm of clinical trials and translational medicine research, the ability to pass information back and forth efficiently has now become a necessity.  The transformation from paper to electronic-based data collection is happening.  Broadly speaking, efficient information exchange and extraction has become so paramount in the networked economy that it has now even become the line of scrimmage for financial firms to compete.    

 

Whenever someone Googles symptoms of a particular disease, that action can be tracked and trends can be traced.  The Fitbit that you bought because it was the next big fad is actually harvesting your biometrics and uploading into the so-called Cloud.  Observational trials are beginning to harness the power of Big Data by exploiting remote sensing technology.  Companies such as Flatiron have already capitalized on this vast information network and pushed the frontiers of oncology research.  According to Ofcom, the average human internet user spends over 20 hours online.  Think about how much time you spend on the computer or your smart phone.  This is a LOT of data that is being transmitted – a proverbial treasure trove of behavioral data. 

 

Whether for better or for worst, when a person spends this significant amount of time in a virtual world, it starts to become alternate reality in which habits are monitored.  In this case, the alternate reality takes place in a world that is structured as a network where the nodes represent computer terminals, and the arcs represent online connections.  One can foolishly dismiss this idea as a philosophical abstraction, but as the boundary separating the physical and virtual realms slowly blurs, it will be necessary for researchers to consider the connecting medium between them and patients. 

 

The main purpose of medical research is to generate knowledge using information.  That is currently done by collecting information from the patients during the clinical trial process.  But what if we can generate this knowledge using a different process to collect high quality information?  Big Data is still not an adequate proxy for clinical trials, but there is potential.  As Jim Carrey’s character once said in the 1996 cult classic, Cable Guy: “Time to take a ride on the information superhighway.” 

 

Aside from the metaphysical implications of Big Data, networks can also provide us a concise representation of international relations.  Using the Clinical Trials Transformative Initiative (CTTI) AACT dataset, it was possible to get a snapshot of the interactions on a country level.  The following figure shows the connections between the clinical trials lead sponsors’ country and the location of facilities (clinical trial sites).  In other words, the countries are the nodes, and the links represent the connection between lead sponsors and sites. These network arcs can also symbolize pathways in which the massive amounts of information flow between sponsors and sites in order to coordinate complex clinical trials enterprises.  One can also say that these arcs represent the economic ties that pharmaceutical companies create as a result of asymmetric policies.  Whatever the interpretation is for the existing connection, it is apparent from the following map that clinical trials are an international phenomenon.  Data is a currency, and can be just as fluid as money.  The following network shows just how far information can be transported.

 

Generated from the CTTI AACT Dataset

 

However, with the onset of hyper connectivity in a globalized world, there’s always a caveat:  Privacy.  Some argue that privacy is a product of culture, while others argue it is a fundamental human right.  In the era of mass data surveillance that exploits a well-connected information network, it can be easy to encroach on people’s personal business.  The act of privacy also includes the ownership of one’s personal information.  Who truly owns your information in this age?  We have all heard of the hazards of identity theft, and its ramifications.  Although I agree with the sentiment of privacy rights, I would find it difficult, if not impossible, to maintain complete ownership of my personal information.  I would argue that in order to maintain complete ownership of your information in modern times, one must move to a remote location somewhere in the forest and engage in the strict practice of Neo-Luddism while devoid of all communication to the outside world.  

 

The true effects of the Health Insurance Portability and Accountability Act (HIPAA) can and has been argued, but nonetheless the need for effective and robust policies is evident.  Even then, you’re probably still photographed by the Google Street View van.  Nevertheless, we will continue to explore these avenues; it is my hope that we develop a solution that will consider the privacy issues of patients while maximizing the utility of information and networks.  We will also consider a wide array of network analysis tools to aid us in this exploration.  In the meantime, please just accept that there is no escape from the Network – we are all part of the Network.

By: 

Gary Lin

Week Notes Authors

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. 

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.

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.

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.

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.

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.

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. 

 

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.

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.

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.

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.

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.