ABSTRACT
One of the most exciting new developments in clinical trial medicine is the emergence of adaptive and £exible clinical trials. The recent maturation of tools necessary for adaptive clinical trials-in particular the development of real-time, Web-based, electronic data entry systems as well as recent advances in statistical methods-has made adaptive clinical trials practical and attractive. Previously, most studies used paper-based case report forms that require weeks or months of time between patient visits and availability of data. Now, modern electronic data capture technology can shorten that time to days or hours. The rapid turnaround between data generation and data availability means that the progress of study can be monitored in real time. This means that the data and the analysis of the data, including endpoints, patient characteristics, and other parameters necessary to make changes in the study can be made available in real time. Without timely availability of these parameters, adaptive clinical studies are not possible.
