ABSTRACT

This chapter presents some closing thoughts on the key concepts discussed in the preceding chapters of this book. The book discusses Alan Shields and colleagues have explored the implications of the extent of the problem with unsupervised paper data collection. In many cases there is considerable experience with the paper system and a corresponding volume of validation data to support its use. The electronic solution must be compared to the paper system and shown to produce equivalent data. The book focuses the methods for this have been discussed by Paul Beatty and Damian McEntegart. It shows some of the ways in which these developments will affect ePRO, and more generally the way in which the patients' involvement in clinical trials will change as patient reported outcomes move beyond what can be done with paper, and indeed moves beyond the collection of outcomes to become a two-way communication system.