APPENDIX TWO
Disclosure of Information and Publication of Results

An ALS Clinical Trial should employ the following Guidelines for Disclosure of Information and Publication of Results:

Before beginning a trial
The clinical investigators, in cooperation with the sponsor, if industry supported, should establish a Data and Safety Monitoring Committee, a Steering Committee and a Publications Committee. This latter committee should establish policy for responsibility, effort, and final authorship as well as policy regarding issues of release and distribution of information and publication.

Information to patients
Guidelines for post-trial drug opportunities (open-label) should be clearly stated at the outset. There should be specific delineation of when results will be revealed to the patients and when safety/efficacy information will be released.

Information disseminated during the trial
Ongoing information should come from the Steering Committee, through each principal investigator to patients.

No trial should be terminated before completion without the significance being so great and the trial analysis so valid that it is no longer ethical to ask patients to take placebo.

Publications of the results of a trial
Upon completion of the trial and analysis, publication should be expeditious, whether positive or negative. The sponsor should not be in a position to prevent publication.

Ownership of the data base
The investigators and sponsor should jointly own the data base subject to proprietary restrictions previously agreed upon. Individual principal investigators should have access to their own data and full publication rights after a pre-specified interval.

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