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Keywords

clinical trial, disengagement, disparity, socioeconomic disadvantage

 

Authors

  1. Rhudy, James P. Jr
  2. Lewis, Jonathan C.
  3. Alexandrov, Andrei V.
  4. Alexandrov, Anne W.

Abstract

ABSTRACT: BACKGROUND: Clinical trialists may be reluctant to enroll socioeconomically disadvantaged participants because of concerns for subject disengagement leading to noncompliance with longitudinal measures and high lost to follow-up (LTFU) rates. OBJECTIVES: We describe the LTFU problem associated with disadvantaged participants and propose strategies to reduce clinical trial disengagement. METHODS: Difficulties encountered in recruiting and retaining socioeconomically disadvantaged participants along with antecedents of disengagement are discussed. Data in the public domain were used to derive, symbolize, and map engagement by census tract. Exemplars of engaged and disengaged clinical trial participants are shared, and geospatial distribution of socio-spatial disengagement risk is presented. RESULTS: Subject disengagement can be visualized by geospatial informatics suggesting areas of low and high socio-spatial disengagement risk. By failing to enroll socioeconomically disadvantaged subjects, researchers may deliberately exclude those who may benefit the most because of significant health disparities. DISCUSSION: We propose a study of realistic LTFU rates for disadvantaged participants. Realistic clinical trial end points and methods may reduce disengagement among disadvantaged participants.