We Have a Challenge

Cambridge MA Roundtable: Carrying on fire alarm and all

We have a challenge: the promise of groundbreaking drugs and devices has never been greater or more apparent. And yet, the system we task with developing, testing and verifying safety and efficacy is struggling to keep up and deliver on this promise.

We have another challenge: an interdisciplinary team–working inter-methodologically­–has been formed from research groups at MIT, Johns Hopkins UniversityMIT, Rhode Island School of Design and Cleveland State University to identify and develop progressive strategies that will enable a more rapid and cost effective clinical trials system. And we would like to communicate our process and early findings with you. How will we do it? We will start with Week Notes.

Our Week Notes will appear here, each week, written by a rotating cast, in an effort to update you the reader about how the project is progressing, our findings, strong and weak signals, methodologies, and all the other material that naturally spins out of an undertaking as complex as ours.

Week Notes are by definition not highly structured or comprehensive. They are intended to provide a glimpse into process for you and a record of thinking and practice for us at a cadence that is too fast for careful prose. We hope that they will pique your interest in our project. If they do, please reach out to us.

For this Week Note, I will just share a bit about what we have done since our soft launch in November 2014 and how our team is structured.

Diagram of our research process

First, to our team: as mentioned, we are an interdisciplinary group of designers and engineers. Central to our philosophy is a systems-based approach and a deliberate resistance to forming an early theory(s) of change. We are working to uncover the root causes of inefficiencies and misalignments and model how these lead to the symptoms that characterize our system today. We engage a diverse stakeholder group who are leaders both domestically and internationally in the fields they represent. Finally, we engage in field research to see how clinical trials are conducted around the world for different kinds of drugs intended to provide therapies for different kinds of patients. At the center of our work is the patient, for whom the system must ultimately be organized around.

NYC Roundtable March 2015

To date we have begun an intensive literature review including journals, industry reports, books and other material to help build a basic understanding of the clinical trials landscape both domestically and internationally. We have reviewed the 21st Century Cures Bill and its White Paper Respondents to better understand the policy landscape.

Washington DC Roundtable, March 2015

We have held three roundtables with leading experts from many fields in Cambridge, New York and Washington DC. These conversations have reinforced our belief in the need for a project such as ours and rapidly increased our understanding of the system.

We have initiated 2 pilot studies. One at Draper Laboratories in Cambridge and one with the Ministry of Health in South Africa. More to come on these projects and the others that will follow.

And within the past few weeks, we have begun to build different kinds of models to explore an interrelated set of research questions. There will be much more to come here as well.

Thank you for reading. Please check back in each week and see what we are up to. And please be in touch!

Justin Cook