Publications

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?” View Details

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

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... View Details

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

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.... View Details

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

January 2014 (Revised June 2014)
Case

23andMe: Genetic Testing for Consumers (A)

By: John A. Quelch and Margaret L. Rodriguez

On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details

Keywords: Public Health; Genome Testing; Health Care; Ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States

Research Summary

Clinical Trials as a setting for Health Policy and Management Research

The clinical trial marketplace is in flux. A decade ago, pharmaceutical firms almost exclusively conducted the study of their novel drug compounds within major academic medical centers. But today, industry-sponsored clinical trials are increasingly using community... View Details

October 2018 (Revised January 2019)
Case

The Financial Crisis: Timothy Geithner and the Stress Tests

By: Samuel G. Hanson, Robin Greenwood, David Scharfstein and Adi Sunderam

In February and March 2009, the U.S. economy was in the midst of a terrifying financial and economic crisis. Between the beginning of 2008 and early 2009, four of the 25 largest U.S. financial institutions had failed, and nine of these 25 institutions had taken... View Details

Keywords: Bailout; Regulation; Stress Test; Financial Crisis; History; Economy; Policy; Governing Rules, Regulations, and Reforms; Decision Making; Banking Industry; Financial Services Industry; Real Estate Industry; United States

Article

Design and Testing of a Mobile Health Application Rating Tool

By: David Levine, Zo Co, Lisa Newmark, Alissa Groisser, A Jay Holmgren, Jennifer Haas and David Bates

Mobile health applications (“apps”) have rapidly proliferated, yet their ability to improve outcomes for patients remains unclear. A validated tool that addresses apps’ potentially important dimensions has not been available to patients and clinicians. The objective of... View Details

Keywords: Health; Mobile Technology; Design; Analysis

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May 2024
Article

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

By: Caroline Marra and Ariel D. Stern

Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting... View Details

Keywords: Health Care and Treatment; Technological Innovation; Product Development; Health Testing and Trials; Governing Rules, Regulations, and Reforms

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March 2016
Case

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... View Details

Keywords: Vaccination; Influenza; Flu Shot; Preventive Care; Health Care; Behavioral Economics; Choice Architecture; Nudge; Experimental Design; Randomized Controlled Trial; RCT; Causal Inference; Consumer Behavior; Health Care and Treatment; Health Testing and Trials; Communication Strategy; Health Industry

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... View Details

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... View Details

Keywords: Health Care; Chronic Disease; Digital Health; Health Acceleration Challenge; Strategy; Disease Management; Health; Health Care and Treatment; Information Technology; Mobile and Wireless Technology; Technology Adoption; Health Industry; United States; Massachusetts

February 2024
Article

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... View Details

Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry

March 2015
Case

Twine Health

By: Robert S. Huckman, Ariel D. Stern and Matthew G. Preble

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... View Details

Keywords: Health Care; Chronic Disease; Technology Adoption; Digital Health; Health Acceleration Challenge; Strategy; Disease Management; Health; Health Care and Treatment; Information Technology; Mobile and Wireless Technology; Health Industry; United States; Massachusetts

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... View Details

Keywords: Health Testing and Trials; Demographics

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November 2008 (Revised July 2009)
Background Note

A Managerial Perspective on Clinical Trials

By: Arthur A. Daemmrich

This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Safety; Biotechnology Industry; Pharmaceutical Industry

August 2023
Article

Impact of Social Needs Case Management on Use of Medical and Behavioral Health Services: Secondary Analysis of a Randomized Controlled Trial

By: Mark D. Fleming, Crystal Guo, Margae Knox, Daniel M. Brown, Elizabeth A. Hernandez and Amanda L. Brewster

Social needs case management is an increasingly common strategy used by health care organizations to address integrated health and social needs. These programs connect patients to resources such as food assistance, housing, transportation, or income benefits, in... View Details

Keywords: Health Care and Treatment; Medical Specialties; Programs; Human Needs; Welfare; Health Industry; California

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September 2020
Case

Minerva 2020: Clinical Trials

By: John R. Wells and Benjamin Weinstock

In March 2020, Dr. Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Inc. (Minerva), was reviewing the first results of human clinical trials for the company’s novel CAR-T drug therapeutic, one of the first ever to target solid cancer tumors. The results... View Details

Keywords: Biotechnology; Strategic Decision Making; Entrepreneurship; Health Testing and Trials; Decision Choices and Conditions; Strategy

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... View Details

Keywords: Health Care; India; Business Training; RCT; Health Care and Treatment; Training; Performance Evaluation; Performance Improvement; India

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October 2018 (Revised September 2020)
Case

Testing Autonomy in Pittsburgh

By: Mitchell Weiss and Brittany Urick

Pittsburgh’s mayor had been among the first to welcome self-driving vehicles but was now one of many needing to react after a pedestrian fatality involving an autonomous Uber in Arizona. He had originally preferred to roll out “the red carpet” instead of the “red... View Details