The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field

Abstract

Objective: In the many clinical studies conducted in the alcoholism field with psychotropic drugs--and throughout the drug development field in medicine, where evaluation of adverse events can be incomplete, arbitrary or misleading--few standardized methods have been developed for assessing adverse events, whereas defining standardized methods for evaluating clinical efficacy is typical. For the National Institute on Alcohol Abuse and Alcoholism COMBINE Study, testing the safety and efficacy of naltrexone and acamprosate, both alone and in combination, in the treatment of alcohol dependence, we adapted a standardized instrument--the Systematic Assessment for Treatment Emergent Events (SAFTEE)--for assessing adverse events in these Phase 2- to Phase 3-type studies.

Method: We standardized use of the SAFTEE with training, supervision and clear guidelines for its implementation, including development of a nomenclature for the typical adverse events associated with these medications and a format for examining symptom severity. Data from the COMBINE SAFTEE include not only frequency of adverse events but also severity level and a composite index taking into account both the severity and duration of symptoms.

Results: The COMBINE SAFTEE was incorporated into the Medical Management therapy and showed high fidelity with its utility, consistency of deliverability and flexibility in measuring adverse events in both the human laboratory and clinical trial settings using intervals that varied from daily to weekly use.

Conclusions: Due to its high standardization level, the COMBINE SAFTEE could be incorporated into other brief compliance enhancement strategies in clinical studies to assess the efficacy of putative therapeutic drugs.