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- 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
- 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
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Supplement 620-001, September 2019.
- 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
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (C)." Harvard Business School Supplement 622-012, July 2021.
- 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
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.)
- 18 Feb 2016
- News
Challenge Aims to Speed Drug Trials Process
clinical trials process. Today, it takes at least 10 years and billions of dollars for one FDA-approved drug to move from research labs to medicine cabinets. Precision medicine will bring faster innovation,... View Details
- 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
Wells, John R., and Benjamin Weinstock. "Minerva 2020: Clinical Trials." Harvard Business School Case 721-391, September 2020.
- 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
Daemmrich, Arthur A. "A Managerial Perspective on Clinical Trials." Harvard Business School Background Note 709-033, November 2008. (Revised July 2009.)
- 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... View Details
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.
- January 2006 (Revised July 2006)
- Case
Drug Testing in Nigeria (A)
By: Debora L. Spar
In 1996, a meningitis epidemic swept across Nigeria. Thousands of children were struck and, lacking appropriate medicine, were liable to die from the disease. Doctors at Pfizer had an antibiotic that could probably save most of these children's lives. The drug was new,... View Details
Keywords: Risk and Uncertainty; Health Pandemics; Health Testing and Trials; Developing Countries and Economies; Pharmaceutical Industry; Nigeria
Spar, Debora L., and Adam Day. "Drug Testing in Nigeria (A)." Harvard Business School Case 706-033, January 2006. (Revised July 2006.)
- 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
Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." Quarterly Journal of Economics 139, no. 1 (February 2024): 575–635.
- August 2005 (Revised December 2006)
- Case
Procter & Gamble: Electronic Data Capture and Clinical Trial Management
By: Robert S. Huckman and Mark J. Cotteleer
Considers whether the management of Procter & Gamble (P&G) Pharmaceuticals should adopt Web-based electronic data capture (EDC) as the default standard for the management of its clinical drug trials. Provides a detailed description of the existing paper-based process... View Details
Keywords: Health Testing and Trials; Internet and the Web; Information Technology; Adoption; Business Processes; Industry Structures; Technological Innovation; Service Operations; Pharmaceutical Industry; United States
Huckman, Robert S., and Mark J. Cotteleer. "Procter & Gamble: Electronic Data Capture and Clinical Trial Management." Harvard Business School Case 606-033, August 2005. (Revised December 2006.)
- 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
- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful... View Details
Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry
Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
- February 2005 (Revised April 2006)
- Case
Rx Depot: Importing Drugs from Canada
By: Debora L. Spar
In 2002, a handful of entrepreneurs began to ship drugs from Canada into the United States, taking advantage of regulatory and price differentials across the neighboring countries. Using the Internet and a low-cost network of Canadian pharmacies, firms like Rx Depot... View Details
Keywords: Courts and Trials; Entrepreneurship; Intellectual Property; Laws and Statutes; Pharmaceutical Industry; Canada; United States
Spar, Debora L., and Adam Day. "Rx Depot: Importing Drugs from Canada." Harvard Business School Case 705-010, February 2005. (Revised April 2006.)
- September 2021
- Article
Trials and Terminations: Learning from Competitors' R&D Failures
I analyze project continuation decisions where firms may resolve uncertainty through news about competitors' research and development (R&D) failures, as well as through their own results. I examine the trade-offs and interactions between product-market competition and... View Details
Krieger, Joshua L. "Trials and Terminations: Learning from Competitors' R&D Failures." Management Science 67, no. 9 (September 2021).
- 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... View Details
- August 2023 (Revised May 2024)
- Case
Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations
By: Satish Tadikonda and Amanda McEwen
The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details
Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry
Tadikonda, Satish, and Amanda McEwen. "Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations." Harvard Business School Case 824-018, August 2023. (Revised May 2024.)