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Exploring the debate at the heart of regulation changes for clinical trials in the United States

In January 2017, the US Department of Health and Human Services (HHS) issued a final rule on long awaited updates to the regulations governing clinical trials in the United States. The purpose of these regulation changes is to increase protections for people who participate in clinical research, in a changing research landscape where data privacy and permanent anonymity for patients is increasingly difficult to guarantee.

In this article, we examine the growing tension between two needs:

- The need to protect patient data and ensure the patients at the heart of clinical research can benefit from the studies they enable.

- The need to maintain the pace of research and take advantage of new technologies that can aid clinical research and healthcare more broadly. 

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