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This document addresses adaptive designs for medical device clinical studies and is applicable to premarket medical device submissions including Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions (Evaluation of Automatic Class III Designation), Humanitarian Device Exemption (HDE) applications and Investigational Device Exemption (IDE) submissions. This guidance can be applied throughout the clinical development program of a medical device, from feasibility studies to pivotal clinical studies. This guidance does not apply to clinical studies of combination products or co-development of a pharmaceutical product with an unapproved/uncleared diagnostic test. However, the underlying principles may be applicable to such studies.
Evidence-based public health decisions are based on evaluations of intervention studies with randomized and nonrandomized designs. Transparent reporting is crucial for assessing the validity and efficacy of these intervention studies, and, it facilitates synthesis of the findings for evidence-based recommendations. Therefore, the mission of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) group is to improve the reporting standards of nonrandomized evaluations of behavioral and public health interventions.
The TREND statement was first published in a special issue of the American Journal of Public Health in March 2004. The issue was devoted to evaluation research. This special issue contains a number of papers related to the use of nonrandomized or quasi-experimental designs in the evaluation of interventions.
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