Lessons learned

Abstract

As the case studies in this series demonstrate, monitoring of a clinical trial is a complex process. No simple algorithm can capture all of the variations and issues.Rather,flexibility and wisdom of a properly constituted monitoring committee are essential. Interpretation of interim analyses depends on the direction of a trend, internal and external consistency, kind and clinical importance of the primary and secondary outcomes and adverse events, and the completeness and timeliness of the accumulating data. We believe, based on the 29 case studies and the other examples, and on our collective experience, that monitoring committees, along with appropriate statistical methodology, have served investigators, sponsors, regulatory agencies, study participants, and the public extremely well. Additional experience will undoubtedly make the process even better. Sharing those experiences, the "lessons learned," is essential to that process. © 2006 Springer-Verlag New York.