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Article | JAMA Cardiology | January 2018

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 Dora Stern

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Abstract

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 patients worldwide. Medical device innovation requires a robust ecosystem that involves medical technology innovators, often at start-ups, large medical device manufacturers, and clinical investigators. Central to this process is strong regulatory oversight, which in the United States is provided by the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (FDA/CDRH). This viewpoint discusses the effect of the regulatory approval process and the role that FDA/CDRH plays in the design and execution of the pivotal trials (clinical studies) that are used to support the regulatory approval of high-risk devices. We also review norms in the publication of pivotal trials in peer-reviewed medical journals; these publications often fail to acknowledge the role of the FDA/CRH or discuss results within the context of the device approval process.

Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States;

Format: Print Find at Harvard

Citation:

Kaplan, Aaron V., and Ariel Dora 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.

About the Author

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Ariel D. Stern
Poronui Associate Professor of Business Administration
Technology and Operations Management

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More from the Author

  • Article | NEJM Catalyst | October 14, 2019

    How Artificial Intelligence Is Changing Health Care Delivery

    Samantha F. Sanders, Mats Terwiesch, William J. Gordon and Ariel Dora Stern

    The development of intelligent machines holds great promise for making health care delivery more accurate, efficient, and accessible, but challenges remain for incorporating AI into clinical and administrative settings.

    Keywords: artificial intelligence; Health Care and Treatment; Service Delivery; Technological Innovation;

    Citation:

    Sanders, Samantha F., Mats Terwiesch, William J. Gordon, and Ariel Dora Stern. "How Artificial Intelligence Is Changing Health Care Delivery." NEJM Catalyst (October 17, 2019).  View Details
    CiteView Details Read Now Related
  • Case | HBS Case Collection | September 2019

    Adaptive Platform Trials: The Clinical Trial of the Future? (B)

    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 platform trial for studying potential therapies for glioblastoma (GBM), an aggressive form of brain cancer. The (B) case provides an update and explores the strategies that Alexander is considering for sustainably financing this trial.

    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:

    Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Case 620-001, September 2019.  View Details
    CiteView DetailsEducators Related
  • Article | Journal of Law, Medicine & Ethics

    Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures.

    Ariel Dora Stern

    The use of biomarkers holds great promise for the development of new therapeutics and the acceleration of clinical research. However, biomarkers must be validated—a complex and costly endeavor. Importantly, biomarker validation is meaningfully shaped by economic and policy-driven incentives.

    Keywords: biomarkers; Information Management; Health Care and Treatment; Motivation and Incentives;

    Citation:

    Stern, Ariel Dora. "Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures." Journal of Law, Medicine & Ethics 47, no. 3 (September 2019): 396–397.  View Details
    CiteView DetailsFind at Harvard Read Now Related
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