A host of pressures — patient recruitment and retention, cost and efficiency, and regulatory — have researchers seeking out novel approaches to clinical trials. Among them are virtual trials, which are often touted as a solution to many of these problems. Still, challenges and concerns remain, resulting in slow industry adoption.
Patient-centeredness has become a hallmark of high-quality research, patient care and drug development — and patient engagement has become a major focus for clinical trial managers (CTMs). Study participants themselves are calling for more input into their care and satisfaction and quality outcomes are clearly tied to one another.
Adaptive trial designs can produce results more quickly and identify patient populations more clearly. But the savings in time and effort during the trial is balanced by the work that must be done in the design stage.
Unlike conventional studies, adaptive clinical trial design calls for ongoing analysis of data and modification of key trial parameters in response to the results. The adaptive trial model requires more extensive protocol planning — regular data analysis points need to be identified and rules created for making decisions about modifications before the trial begins.
Adaptive clinical trial design has been making its way from oncology and other specialty fields into the broader world of pharmaceutical and biologic studies. While adaptive design can offer many benefits for clinical investigators and sponsors, those conducting such trials can be easily tripped up in two areas: adequate, detailed planning of the design; and data control during the interim analysis that is the hallmark of adaptive design. Read More