Implementation Issues in Adaptive Design Trials

Abstract

In this chapter we discuss operational challenges that are specific to adaptive trials (as well as complex nonadaptive trials): essentially, the need to validate the design, to control the trial centrally, to collect and analyze key data rapidly, to preserve the trial blinding and integrity, and to document all important adaptive decisions taken. We illustrate these challenges using an actual phase I trial in oncology, and argue that the issues can be addressed through proper planning, choice of experienced vendors and independent groups (coordinating center and DSMB), statistical teams with adequate expertise in the design chosen (randomization and CRM), recourse to efficient computer technology (IWRS, EDC, automated e-mailing), and oversight by a team that must be as flexible as the trial design!