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Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development

Publication Date
Easter Research Group, Inc.

This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages. Among others, some of the strategies examined included mobile technologies, simplified clinical trial protocols and reduced amendments, reduced source data verification, staged approval and centralized institutional review boards. This environmental scan also includes estimates of how adoption of the identified strategies may impact cost, duration, and phase transition probabilities gathered from subject matter experts. Results from this study can be helpful in understanding the potential cost of medical product development.

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