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- Faculty Publications (61)
- Article
Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era
By: William J. Gordon, Andrea Coravos and Ariel Dora Stern
From clinical trials to care delivery, advanced, digitally enabled technologies and analytics offer new approaches to how we think about medicine, health, and biology. The COVID-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years...
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Gordon, William J., Andrea Coravos, and Ariel Dora Stern. "Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era." npj Digital Medicine 4, no. 56 (2021).
- 2021
- Working Paper
The Health Costs of Cost-Sharing
By: Amitabh Chandra, Evan Flack and Ziad Obermeyer
We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in...
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Chandra, Amitabh, Evan Flack, and Ziad Obermeyer. "The Health Costs of Cost-Sharing." NBER Working Paper Series, No. 28439, February 2021.
- June 2021
- Article
From Predictions to Prescriptions: A Data-driven Response to COVID-19
By: Dimitris Bertsimas, Léonard Boussioux, Ryan Cory-Wright, Arthur Delarue, Vassilis Digalakis Jr, Alexander Jacquillat, Driss Lahlou Kitane, Galit Lukin, Michael Lingzhi Li, Luca Mingardi, Omid Nohadani, Agni Orfanoudaki, Theodore Papalexopoulos, Ivan Paskov, Jean Pauphilet, Omar Skali Lami, Bartolomeo Stellato, Hamza Tazi Bouardi, Kimberly Villalobos Carballo, Holly Wiberg and Cynthia Zeng
The COVID-19 pandemic has created unprecedented challenges worldwide. Strained healthcare providers make difficult decisions on patient triage, treatment and care management on a daily basis. Policy makers have imposed social distancing measures to slow the disease, at...
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Keywords:
COVID-19;
Health Pandemics;
AI and Machine Learning;
Forecasting and Prediction;
Analytics and Data Science
Bertsimas, Dimitris, Léonard Boussioux, Ryan Cory-Wright, Arthur Delarue, Vassilis Digalakis Jr, Alexander Jacquillat, Driss Lahlou Kitane, Galit Lukin, Michael Lingzhi Li, Luca Mingardi, Omid Nohadani, Agni Orfanoudaki, Theodore Papalexopoulos, Ivan Paskov, Jean Pauphilet, Omar Skali Lami, Bartolomeo Stellato, Hamza Tazi Bouardi, Kimberly Villalobos Carballo, Holly Wiberg, and Cynthia Zeng. "From Predictions to Prescriptions: A Data-driven Response to COVID-19." Health Care Management Science 24, no. 2 (June 2021): 253–272.
- December 2020 (Revised January 2022)
- Supplement
Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (B)
By: Linda A. Hill and Emily Tedards
In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone three large-scale mergers and acquisitions. As Ku and his new leadership team set out to build a proactive, end-to-end, digital and physical clinical...
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Keywords:
Digital Technology;
Customer-centricity;
Innovation;
Customer Focus;
Talent;
Talent Management;
Leadership;
Innovation and Invention;
Transformation;
Organizational Culture;
Customer Focus and Relationships;
Change Management;
Talent and Talent Management;
Supply Chain;
Mission and Purpose
Hill, Linda A., and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (B)." Harvard Business School Supplement 421-037, December 2020. (Revised January 2022.)
- September–October 2020
- Article
The Past, Present, and (Near) Future of Gene Therapy and Gene Editing
By: Julia Pian, Amitabh Chandra and Ariel Dora Stern
Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the likely trajectory of genetically focused...
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Keywords:
Gene Therapy;
Gene Editing;
Impact;
Health Care and Treatment;
Technological Innovation;
Health Testing and Trials;
Venture Capital;
Change
Pian, Julia, Amitabh Chandra, and Ariel Dora Stern. "The Past, Present, and (Near) Future of Gene Therapy and Gene Editing." NEJM Catalyst Innovations in Care Delivery 1, no. 5 (September–October 2020).
- Article
Quantifying the Use of Connected Digital Products in Clinical Research
By: Caroline Marra, Jacqueline L. Chen, Andrea Coravos and Ariel D. Stern
Over recent years, the adoption of connected technologies has grown dramatically, with potential for improving health care delivery, research, and patient experience. Yet, little has been documented about the prevalence and use of connected digital products (e.g.,...
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Keywords:
Connected Digital Products;
Clinical Trials;
Health Testing and Trials;
Information Technology;
Research
Marra, Caroline, Jacqueline L. Chen, Andrea Coravos, and Ariel D. Stern. "Quantifying the Use of Connected Digital Products in Clinical Research." Art. 50. npj Digital Medicine 3 (2020).
- March 2020 (Revised June 2023)
- Case
EyeControl: Inspiring Communication
By: Paul A. Gompers and Danielle Golan
Eye-controlled communication device startup EyeControl was founded in Tel Aviv, Israel in 2016 by cofounders with a shared personal connection to locked-in syndrome—a neurological disorder that left sufferers cognitively sound, yet paralyzed, with the exception of eye...
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Keywords:
Health Disorders;
Communication Technology;
Business Startups;
Expansion;
Finance;
Decision Making;
Social Enterprise;
Medical Devices and Supplies Industry
Gompers, Paul A., and Danielle Golan. "EyeControl: Inspiring Communication." Harvard Business School Case 820-078, March 2020. (Revised June 2023.)
- December 2019
- Technical Note
Technical Note on Bayesian Statistics and Frequentist Power Calculations
By: Amitabh Chandra and Ariel Dora Stern
This Technical Note provides an introduction to Bayes’ Rule and the statistical intuition that stems from it. In this note, we review the concepts that underlie Bayesian statistics, and we offer several simple mathematical examples to illustrate applications of Bayes’...
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Chandra, Amitabh, and Ariel Dora Stern. "Technical Note on Bayesian Statistics and Frequentist Power Calculations." Harvard Business School Technical Note 620-032, December 2019.
- October 2019
- Article
Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
By: Derek C. Angus, Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen and Janet Woodcock
Researchers, clinicians, policymakers, and patients are increasingly interested in questions about therapeutic interventions that are difficult or costly to answer with traditional, free-standing, parallel-group randomized controlled trials (RCTs). Examples include...
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Angus, Derek C., Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen, and Janet Woodcock. "Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations." Nature Reviews: Drug Discovery 18, no. 10 (October 2019): 797–807.
- September 2019
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (B)
By: Ariel D. Stern and Sarah Mehta
This case provides an update to the (A) case, which introduces students to adaptive platform trials, an ambitious, more efficient type of clinical trial that increases access to therapies. The (A) case centers on Dr. Brian Alexander’s efforts to launch an adaptive...
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Keywords:
Clinical Trials;
Drug Trials;
Drug Testing;
Cancer Trials;
Glioblastoma;
Platform Trials;
Adaptive Trials;
Adaptive Platform Trials;
Health Testing and Trials;
Health Care and Treatment;
Financing and Loans;
Business Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Supplement 620-001, September 2019.
- Article
Effect of Different Financial Incentive Structures on Promoting Physical Activity Among Adults: A Randomized Clinical Trial
By: Chethan Bachireddy, Andrew Joung, Leslie K. John, Francesca Gino, Bradford Tuckfield, Luca Foschini and Katherine L. Milkman
Importance: Few adults engage in recommended levels of physical activity. Financial incentives can promote physical activity, but little is known about how their structure influences their effectiveness; for example, whether incentives are more effective if they are...
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Bachireddy, Chethan, Andrew Joung, Leslie K. John, Francesca Gino, Bradford Tuckfield, Luca Foschini, and Katherine L. Milkman. "Effect of Different Financial Incentive Structures on Promoting Physical Activity Among Adults: A Randomized Clinical Trial." JAMA Network Open 2, no. 8 (August 2019): 1–13.
- November 2018
- Case
David Hysong and SHEPHERD Therapeutics
By: Ananth Raman, John Masko and Aldo Sesia
In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his...
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- 2018
- Chapter
The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century
By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new...
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Keywords:
Health Care and Treatment;
Laws and Statutes;
Research and Development;
Investment;
Markets;
Monopoly
Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
- March 2018
- Teaching Note
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
This teaching note provides guidance and recommendations for teaching HBS Case No. 618-025, entitled “Adaptive Platform Trials: The Clinical Trial of the Future?”
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- March 2018
- Teaching Note
Twine Health
By: Robert S. Huckman and Ariel D. Stern
In late 2014, Dr. John Moore (CEO), Frank Moss (chairman), and Scott Gilroy (CTO) of Twine Health (Twine) had to resolve several challenges that threatened to restrict the widespread dissemination of its sole product, Twine. Twine was a cloud-based platform that...
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- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...
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Keywords:
Health Testing and Trials;
Business and Government Relations;
Governing Rules, Regulations, and Reforms;
Information Publishing;
Medical Devices and Supplies Industry;
United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- September 2017 (Revised July 2023)
- Case
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
In July 2017, Dr. Brian M. Alexander, president and CEO of the AGILE Research Foundation, was preparing to launch a new type of clinical trial—an adaptive platform trial—to study potential therapies for glioblastoma (GBM), an aggressive form of brain cancer....
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Keywords:
Clinical Trials;
Cancer;
Adaptive Platform Trials;
Platform Trials;
Adaptive Trials;
Glioblastoma;
Health;
Health Care and Treatment;
Health Testing and Trials;
Business Strategy;
Innovation Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future?" Harvard Business School Case 618-025, September 2017. (Revised July 2023.)
- July 31, 2017
- Article
A Commitment Contract to Achieve Virologic Suppression in Poorly Adherent Patients with HIV/AIDS
By: Marcella Alsan, John Beshears, Wendy S. Armstrong, James J. Choi, Brigitte C. Madrian, Minh Ly T. Nguyen, Carlos Del Rio, David Laibson and Vincent C. Marconi
Objective: Assess whether a commitment contract informed by behavioral economics leads to persistent virologic suppression among HIV-positive patients with poor antiretroviral therapy (ART) adherence.
Design: Single-center pilot randomized clinical trial and a...
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Keywords:
Adherence;
Antiretroviral Therapy;
Behavioral Economics;
Commitment Contract;
Financial Incentives;
HIV-1 Virologic Suppression;
Health Disorders;
Motivation and Incentives
Alsan, Marcella, John Beshears, Wendy S. Armstrong, James J. Choi, Brigitte C. Madrian, Minh Ly T. Nguyen, Carlos Del Rio, David Laibson, and Vincent C. Marconi. "A Commitment Contract to Achieve Virologic Suppression in Poorly Adherent Patients with HIV/AIDS." AIDS 31, no. 12 (July 31, 2017): 1765–1769.
- 2017
- Article
The Impact of Training Informal Healthcare Providers in India: A Randomized Controlled Trial
By: Jishnu Das, Abhijit Chowdhury, Reshmaan Hussam and Abhijit Banerjee
Health care providers without formal medical qualifications provide more than 70% of all primary care in rural India. Training these informal providers may be one way to improve the quality of care where few alternatives exist. We report on a randomized controlled...
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Keywords:
Health Care;
India;
Business Training;
RCT;
Health Care and Treatment;
Training;
Performance Evaluation;
Performance Improvement;
India
Das, Jishnu, Abhijit Chowdhury, Reshmaan Hussam, and Abhijit Banerjee. "The Impact of Training Informal Healthcare Providers in India: A Randomized Controlled Trial." Science 354, no. 6308 (October 7, 2016): 80.
- March 2016 (Revised March 2022)
- Teaching Note
Evive Health and Workplace Influenza Vaccinations
By: John Beshears
Evive Health is a company that manages communication campaigns on behalf of health insurance plans and large employers. Using big data techniques and insights from behavioral economics, Evive deploys targeted and effective messages that improve individuals' health...
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Keywords:
Vaccination;
Influenza;
Flu Shot;
Preventive Care;
Health Care;
Behavioral Economics;
Choice Architecture;
Nudge;
Experimental Design;
Randomized Controlled Trial;
RCT;
Causal Inference;
Health Care and Treatment;
Insurance;
Health;
Consumer Behavior;
Health Testing and Trials;
Communication Strategy;
Insurance Industry;
Health Industry