Our process

​The Clinical Trials Systems Project utilizes systems thinking and design principles to visualize the current clinical trials system, analyze the gaps and impediments in the current system, and develop a portfolio of recommendations for improving the system. Our process is unique in that our multidisciplinary team consists of researchers who are outsiders to the clinical trials system, but experts in their own field.

We did not start with any hypothesis, and utilized systems thinking throughout the project. Systems-thinking looks at the inter connectivity of actions and studies a problem as a whole. This approach considers the system as a sum of its parts where a change in any one part has system-wide ramifications. This enabled us to discover areas that have not yet been addressed by other groups but will have a major impact on the clinical trials system as a whole.

We collaborated with a broad range of expert and non-expert stakeholders through all phases of the project to develop a set of relevant, systems based proposals.

RESEARCH PHASE

In this phase we used literature reviews, interviews with industry experts, and site visits, to inform our team of systems experts about the Clinical Trials system process on all levels.

RELEVANT WEEKNOTES:

March 30, 2015

We Have a Challenge

April 6, 2015

The clinical trials process needs to be modeled

April 13, 2015

Dynamic boundaries and system-solving

April 20, 2015

Site Visit to the Chris Hani Baragwanath Hospital in Soweto

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Common Language

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CT Gantt

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FDA SysML

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SYNTHESIS PHASE

The multidisciplinary team analysed observations and findings developed in the research phase. This helped us identify barriers as well as opportunities to enabling a culture change in Clinical Trials to allow us to begin envisioning pathways to a desired end state.

RELEVANT WEEKNOTES:

January 11, 2016

A New Year with a Plan for Digging Deep into the Gaps and Impediments of the Clinical Trials System

January 21, 2016

Law and Regulation in a Systems Setting

January 25, 2016

Conducting Clinical Trials in a Blizzard

February 8, 2016

The Culture of Clinical Trials

February 16, 2016

Overhauling healthcare: lessons from a small Baltic nation

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Combo chart

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Final Info Presentation

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Game Theory Models

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Networked Health System

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Network Model

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IDEATION PHASE

In the ideate phase, we expanded our discussions to come up with over 25 recommendations that we envisioned could cause change in the system. We then narrowed these down so that we can have a manageable, targeted, and comprehensive portfolio of systems solutions. We put our recommendations through a filter composed of three lenses: the desirability, feasibility, and viability of these recommendations.

RELEVANT WEEKNOTES:

January 13, 2017

Michele Reveals What’s on Her iPhone

April 3, 2017

Specific Solutions, Broad Impacts

April 24, 2017

What kind of system do we want?

May 1, 2017

Getting to solutions

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Ideating Workshop

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RECOMMENDATIONS

In this phase, we created a detailed plan of action with identified stakeholder partners and projected outcomes.

RELEVANT WEEKNOTES:

July 24, 2017

An iterative update

August 14, 2017

Getting the word out

September 25, 2017

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

October 9, 2017

Bridging the Collaboration Gap: New Math in the Clinical Trials System

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Data Ecosystem

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New Math

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Unleash Feedback

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Get the Word out

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Our people

Project Team
Advisors

Strategic Advisory Group

Clayton Christensen PhD
Kim B. Clark Professor of Business Administration, Harvard Business School
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
Robert Langer, ScD
Institute Professor, MIT
T.E. Schlesinger, PhD
Benjamin T. Rome Dean, Professor of Electrical and Computer Engineering, Whiting School of Engineering, Johns Hopkins University
Lawrence H. Summers, PhD
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
Maria T. Zuber, PhD
Vice President for Research, MIT

Expert Advisory Group

Dennis A. Ausiello, MD
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
Jorge Insuasty, MD
Vice President for R&D, Deputy to the President for Development, Sanofi
Freda C. Lewis-Hall, MD
Chief Medical Officer, Pfizer
Megan McBride, MPH
Associate Director, Clinical Trial Innovation, Janssen Pharmaceutical Companies of J&J
Alex (Sandy) Pentland, PhD
Toshiba Professor of Media Arts and Sciences; Director, Media Lab Entrepreneurship Program, MIT
Mike Poole, MD
Director, Global Health Office of the President, Bill & Melinda Gates Foundation
Pamela TenaertsMD, MBA
Executive Director, Clinical Trials Transformation Initiative (CTTI), Duke University
Deborah A. Zarin, MD
Director, ClinicalTrials.gov, National Library of Medicine