THE PROTOCOL DEVIATION PATIENT - CHARACTERIZATION AND IMPLICATIONS FOR CLINICAL-TRIALS RESEARCH

This paper addresses those patients who neither complete treatment nor drop out from clinical trials but who deviate from the protocol treat ment by seeking or receiving additional treatment. Psychotherapy resea rchers may be missing important information by withdrawing these: pati ents from analyses or combining them with dropouts from treatment. In a multisite psychotherapy outcome study for patients with cocaine depe ndence, patients who deviated from protocol could be distinguished fro m completers and dropouts on pretreatment patient characteristics. Pat ients who deviated from protocol were more likely to be African Americ an, to have higher psychiatric severity, and to have had more previous drug treatment attempts. Data indicate that there is a value in obtai ning follow-up assessment after the protocol deviation and including t hese patients in data analysis to avoid bias in findings. Differential outcome for protocol deviation patients compared to dropouts and comp leters is discussed.