Operation TrialBlazer: Is This The Spark America’s Clinical Research Needs?

The U.S. Department of Health and Human Services (HHS) has launched a department-wide clinical trials reform initiative branded as Operation TrialBlazer.¹ HHS is positioning this as an effort to bring early-stage clinical research back to the U.S., accelerate drug development, and restore American competitiveness. The announcement identifies a real issue in that clinical research sponsors increasingly see other countries as faster, cheaper, and more predictable places to generate early human data. HHS’ proposed remedy is a coordinated set of regulatory, technological, and operational changes across its operating divisions including:

• Food and Drug Administration (FDA),
• National Institutes of Health (NIH),