Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa

Abstract

Objective: To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN).

Method: The original aim was to enter 240 participants with AN to one of four cells: Behavioral family therapy (BFT) plus fluoxetine; BFT plus placebo; systems family therapy (SFT) plus fluoxetine; SFT plus placebo.

Results: Recruitment was delayed pending a satisfactory resolution concerning participant safety. After 6 months of recruitment it became clear that the medication was associated with poor recruitment leading to a study redesign resulting in a comparison of two types of family therapy with a projected sample size of 160. One site was unable to recruit and was replaced.

Discussion: Problems with the delineation of safety procedures, recruitment, re-design of the study, and replacement of a site, were the main elements resulting in a 1-year delay. Suggestions are made for overcoming such problems in future AN trials.

Figure 1

Graph showing the rates of study contacts, assessment, and study entries for all sites combined. The medication arm of the study was removed (including DSMB and sites IRB approval) on January 1, 2009 and the Stanford site began recruiting at the same time.