Inclusive Trial Designs in Acute Spinal Cord Injuries: Prediction-Based Stratification of Clinical Walking Outcome and Projected Enrolment Frequencies.

ABSTRACT:

Background

New therapeutic approaches in neurological disorders are progressing into clinical development. Past failures in translational research have underlined the critical importance of selecting appropriate inclusion criteria and primary outcomes. Narrow inclusion criteria provide sensitivity, but increase trial duration and cost to the point of infeasibility, while broader requirements amplify confounding, increasing the risk of trial failure. This dilemma is perhaps most pronounced in spinal cord injury (SCI), but applies to all neurological disorders with low frequency and/or heterogeneous clinical manifestations.

Objective

Stratification of homogeneous patient cohorts to enable the design of clinical trials with broad inclusion criteria.

Methods

Prospectively

SUBMITTER: Cathomen A 

PROVIDER: S-EPMC9003761 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature