Consensus guidelines far the design and implementation of clinical trials in ALS

Background: In 1994 consensus guidelines were developed for conducting clin ical trials in ALS. With growing experience in clinical trials, it has beco me clear that a number of further guidelines were needed. Methods: Under th e auspices of the World Federation of Neurology Committee on Research, a mu ltinational group of neurologists, statisticians, patient advocates, repres entatives from the pharmaceutical industry as well as regulatory agencies d eveloped consensus about a number of revisions to the existing guidelines d uring a 2 day conference in April 1998. Results: Expanded areas of focus in clude greater protection of patient rights, more detailed guidelines for ou tcome measures statistical analyses, disclosure of study results and improv ed interaction between investigators and the corporate sector. Comment: Sub stantial progress has been made in standardizing and improving the quality of clinical trials in ALS through these consensus guidelines. (C) 1999 Else vier Science B.V. All rights reserved.