Guidelines for fracture healing assessments in clinical trials. Part I: definitions and endpoint committees.

Abstract

Patients sustaining long bone fractures experience a significant socioeconomic burden. Investigational products are in developmental phases in an attempt to significantly reduce the time to fracture healing, however, high quality clinical trials need to be conducted in order to evaluate the efficacy of these interventions. The assessment of fracture healing is not a standardised process as it involves a degree of subjectivity. The use of endpoint Adjudication Committees to adjudicate fracture healing in clinical trials has the potential to help to resolve this issue. This manuscript outlines the current definitions used in the assessment of fracture healing and highlights the need for endpoint Adjudication Committees in fracture healing trials.