Abstract

Policy should be directed toward increased scientific rigor in clinical trails, not rigor mortis of the review process. New technologies such as biomedical imaging can increase rigor by providing objective, quantitative measures of device efficacy. Furthermore, a variety of digital technologies for management of clinical trails data and for computerization of the regulatory submission and review process should also be encouraged. In sum, policy should encourage technologies that facilitate the clinical trails and regulatory review process, while increasing scientific rigor.

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