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Clinical trial fraud: Mitigating risk with a compliance program framework

Danielle M. Santiago ( is Associate Director, Corporate Compliance – Clinical Transparency, Otsuka America Pharmaceutical Inc., Doral, FL.

The information contained in this article reflects the author’s own views and experience and do not necessarily reflect the views of Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization Inc., their parent, or any of their subsidiaries or affiliates.

The recent spotlight on the pathway to vaccine development during the COVID-19 pandemic has heightened discussion around science, clinical trial processes, clinical data collection, and the data used to support vaccines and other drug development. Political discussions on the vaccine debate aside, clinical trial conduct may seem secretive and, at times, perhaps not transparent to those unfamiliar. Questioning science and clinical trials hints at underlying implications of fraud or misconduct. However, clinical trial fraud or, more appropriately called, research misconduct, is not a new topic that came with the fury of clinical trial research during the pandemic. In the last few years, clinical trial fraud has been at the forefront of many highly publicized cases brought by the Department of Justice (DOJ).

In December 2021, at the Food and Drug Law Institute Conference, the DOJ announced that clinical trial fraud would be one of four enforcement focus areas for the agency. The announcement delivered by Deputy Assistant Attorney General Arun Rao highlighted the work of the Consumer Protection Branch of the DOJ around the importance of protecting Americans’ health, safety, and economic security.[1] The Department of Health & Human Services’ Office of Research Integrity (ORI) defines research misconduct as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”[2] Research misconduct can include omitting, altering, fabricating, or broadly interpreting clinical data. This can happen when a researcher conducts a clinical trial, during the design of the clinical trial by a sponsor, during data recording within a clinical trial, and when someone supervises or reviews the research taking place. An individual can also commit research misconduct when results are reported either to a public registry or a clinical trial sponsor. This article will discuss notable past enforcement actions by the DOJ to highlight the ways in which clinical trial fraud may appear and ways that clinical trial sponsors/pharmaceutical companies can mitigate the risk surrounding clinical trial fraud in their compliance programs.

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