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- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
- Working Paper
Representation and Extrapolation: Evidence from Clinical Trials
By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
This article examines the consequences and causes of low enrollment of Black patients in clinical
trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is
more relevant for decision-making by physicians and patients when it...
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Keywords:
Representation;
Racial Disparity;
Health Testing and Trials;
Race;
Equality and Inequality;
Innovation and Invention;
Pharmaceutical Industry
Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." NBER Working Paper Series, No. 30575, October 2022. (Revise and resubmit, Quarterly Journal of Economics.)
- 2022
- Working Paper
Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina
By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its...
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Keywords:
COVID-19;
Drug Treatment;
Health Pandemics;
Health Care and Treatment;
Decision Making;
Outcome or Result;
Argentina
Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
- April 2022
- Teaching Note
CVS Health: Prescription for Transformation
By: Rosabeth Moss Kanter and Catarina Martinez
In 2021, new CEO Karen Lynch (named the most powerful woman in business) considered the next transformation phase for CVS Health (a Fortune 5 corporate giant). The 2018 acquisition of Aetna insurance brought her to the company as part of its long evolution from a...
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Keywords:
Health;
COVID-19 Pandemic;
Primary Care;
Leadership;
Change Management;
Women Executives;
Retail;
Pharmacy;
Pharmacy Benefit Manager;
Clinical Trials;
Vaccination;
Acquisition;
Innovation and Invention;
Transformation;
Retail Industry;
Pharmaceutical Industry;
Health Industry;
United States
- February 2022
- Case
Leading The UK Vaccine Task Force
By: Amy C. Edmondson and Claudia Pienica
This case describes the first six months of the UK Vaccine Taskforce, under the leadership of Kate Bingham. With a career spent in the private sector as a biotech investor, Bingham’s appointment within the government was considered unusual. The overarching brief given...
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Keywords:
COVID-19;
Vaccine;
Government;
Health Pandemics;
Health Care and Treatment;
Science;
Innovation and Invention;
Groups and Teams;
Leadership;
Decision Making;
Government and Politics;
Health;
Innovation and Management;
Governance;
Change;
Government Administration;
Health Industry;
Financial Services Industry;
Public Administration Industry;
Europe;
United Kingdom
Edmondson, Amy C., and Claudia Pienica. "Leading The UK Vaccine Task Force." Harvard Business School Case 622-079, February 2022.
- February 15, 2022
- Article
How Managers Can Build a Culture of Experimentation
By: Frank V. Cespedes and Neil Hoyne
Testing in business presents qualitatively different challenges than those in clinical trials and most scientific research. There are very few opportunities for randomized control experiments in a changing, competitive market. Yet, change and competition make testing a...
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Cespedes, Frank V., and Neil Hoyne. "How Managers Can Build a Culture of Experimentation." Harvard Business Review Digital Articles (February 15, 2022).
- January 17, 2022
- Article
Reducing Racial Disparities in Cancer Outcomes
By: Kathy Giusti and Richard G. Hamermesh
A disproportionate number of Black patients die from cancer in the United States. A key to addressing this problem is enrolling more Black patients in clinical trials. A strategy consisting of these three parts can help accomplish this goal: 1) centralize information...
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Giusti, Kathy, and Richard G. Hamermesh. "Reducing Racial Disparities in Cancer Outcomes." Harvard Business Review (website) (January 17, 2022).
- October 2021 (Revised January 2022)
- Supplement
Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)
By: Linda A. Hill and Emily Tedards
This case is the third installment in a series about the 10-year cultural and digital transformation of Pfizer’s Global Clinical Supply organization. In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone...
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Keywords:
Clinical Supply Chain;
COVID-19;
Vaccine;
Agile;
Innovation and Invention;
Change Management;
Organizational Culture;
Transformation;
Leadership;
Corporate Strategy;
Health Pandemics;
Crisis Management;
Mission and Purpose;
Health Care and Treatment;
Supply Chain Management;
Digital Transformation
Hill, Linda A., and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)." Harvard Business School Supplement 422-041, October 2021. (Revised January 2022.)
- July 2021
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (C)
By: Ariel D. Stern and Sarah Mehta
This (C) case provides an update on the work of the Global Coalition for Adaptive Research (GCAR) and also illustrates how adaptive platform trials can nimbly respond to a global pandemic.
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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;
Business Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (C)." Harvard Business School Supplement 622-012, July 2021.
- June 11, 2021
- Article
Addressing Demographic Disparities in Clinical Trials
By: Kathy Giusti, Richard G. Hamermesh and Mark Krasnow
Disparities in health care are not just limited to the delivery of care. They also exist in the way that clinical trials are structured. Women, people of color, and the elderly often are not adequately represented. This article offers three strategies for addressing...
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Giusti, Kathy, Richard G. Hamermesh, and Mark Krasnow. "Addressing Demographic Disparities in Clinical Trials." Harvard Business Review Digital Articles (June 11, 2021).
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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Keywords:
Connected Digital Products;
Telehealth;
Remote Monitoring;
Health Testing and Trials;
Research;
Governing Rules, Regulations, and Reforms;
Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- 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.
- 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
- 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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- 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.