Skip to Main Content
HBS Home
  • About
  • Academic Programs
  • Alumni
  • Faculty & Research
  • Baker Library
  • Giving
  • Harvard Business Review
  • Initiatives
  • News
  • Recruit
  • Map / Directions
Faculty & Research
  • Faculty
  • Research
  • Featured Topics
  • Academic Units
  • …→
  • Harvard Business School→
  • Faculty & Research→
  • Research
    • Research
    • Publications
    • Global Research Centers
    • Case Development
    • Initiatives & Projects
    • Research Services
    • Seminars & Conferences
    →
  • Publications→

Publications

Publications

Filter Results : (51) Arrow Down
Filter Results : (51) Arrow Down Arrow Up

Show Results For

  • All HBS Web  (208)
    • Faculty Publications  (51)

    Show Results For

    • All HBS Web  (208)
      • Faculty Publications  (51)

      Clinical Trials Remove Clinical Trials →

      Page 1 of 51 Results →

      Are you looking for?

      → Search All HBS Web
      • 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...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
      Citation
      Find at Harvard
      Purchase
      Related
      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...  View Details
      Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
      Citation
      Find at Harvard
      Read Now
      Purchase
      Related
      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...  View Details
      Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina
      Citation
      Find at Harvard
      Read Now
      Related
      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...  View Details
      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
      Citation
      Purchase
      Related
      Kanter, Rosabeth Moss, and Catarina Martinez. "CVS Health: Prescription for Transformation." Harvard Business School Teaching Note 322-122, April 2022.
      • 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...  View Details
      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
      Citation
      Educators
      Purchase
      Related
      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...  View Details
      Keywords: Experimentation; Management; Decision Making
      Citation
      Find at Harvard
      Read Now
      Related
      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...  View Details
      Keywords: Cancer Trials; Racial Disparity; Health Testing and Trials; Race; Strategy
      Citation
      Read Now
      Related
      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...  View Details
      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
      Citation
      Purchase
      Related
      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.  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
      Citation
      Purchase
      Related
      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...  View Details
      Keywords: Health Testing and Trials; Demographics
      Citation
      Find at Harvard
      Register to Read
      Related
      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...  View Details
      Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
      Citation
      Find at Harvard
      Read Now
      Related
      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...  View Details
      Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology
      Citation
      Read Now
      Related
      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...  View Details
      Keywords: Digital Medicine; Health Care and Treatment; Technological Innovation; Safety; Ethics
      Citation
      Read Now
      Related
      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...  View Details
      Keywords: Cost-sharing; Impact; Health Care and Treatment; Insurance; Health; Consumer Behavior
      Citation
      Read Now
      Related
      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...  View Details
      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
      Citation
      Purchase
      Related
      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...  View Details
      Keywords: Gene Therapy; Gene Editing; Impact; Health Care and Treatment; Technological Innovation; Health Testing and Trials; Venture Capital; Change
      Citation
      Find at Harvard
      Read Now
      Related
      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.,...  View Details
      Keywords: Connected Digital Products; Clinical Trials; Health Testing and Trials; Information Technology; Research
      Citation
      Read Now
      Related
      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...  View Details
      Keywords: Health Disorders; Communication Technology; Business Startups; Expansion; Finance; Decision Making; Social Enterprise; Medical Devices and Supplies Industry
      Citation
      Educators
      Related
      Gompers, Paul A., and Danielle Golan. "EyeControl: Inspiring Communication." Harvard Business School Case 820-078, March 2020.
      • 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’...  View Details
      Keywords: Bayesian Statistics; Mathematical Methods
      Citation
      Educators
      Purchase
      Related
      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...  View Details
      Keywords: Adaptive Platform Trials; Health Testing and Trials
      Citation
      Find at Harvard
      Read Now
      Related
      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.
      • 1
      • 2
      • 3
      • →

      Are you looking for?

      → Search All HBS Web
      ǁ
      Campus Map
      Harvard Business School
      Soldiers Field
      Boston, MA 02163
      →Map & Directions
      →More Contact Information
      • Make a Gift
      • Site Map
      • Jobs
      • Harvard University
      • Trademarks
      • Policies
      • Accessibility
      • Digital Accessibility
      Copyright © President & Fellows of Harvard College