Clinical trials and tribulations: Implementation processes in schizophrenia research outcome

THIS article focuses on an area in clinical drug trials for new antipsychot ic medications for the treatment of schizophrenia which has not received su fficient attention in the literature: the day-to-day implementation tasks p erformed by research staff which have potential effects on study results. I mplementation tasks are viewed as dynamic processes involving interactions among research and nonresearch staff, patients, families, and pharmaceutica l company staff. Research-related demands and possible sources of stress fo r all participants in the process, such as recruiting and maintaining patie nts in studies, are discussed. Suggestions are offered for increasing the e ase of participation. Further investigation is called for in several areas including variability in the effectiveness of research teams and in the rar ely discussed interactions between site staff and pharmaceutical company pe rsonnel, as they may affect research outcomes. It is posited that increased knowledge about implementation processes in schizophrenia drug development is needed to more fully understand study results and to enhance patients' and their families' willingness to participate.