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DR. LUDWIG GUTMANN: This panel discussion will deal with communications, ALS trial information sharing, and how we may want to conduct ALS trials in the future. There are a number of important issues to discuss, including the issue of national, international, or regional study groups and consortia. ALS CARE is a very exciting step forward into the same kind of arena that oncologists developed years ago in the United States. I hope we will deal with the question of consensus on outcome. We have all been impressed by not only the quality of some of the research trials, but also that we are looking at different outcome measurements. Dr. Brooke will comment on the use of Internet and the project he is developing for the American Academy of Neurology. We need to address the importance of physiciandriven research consortia, and Dr. Mitsumoto will discuss the pharmaceutical company consortia with which he is involved.
DR. DANIEL DRACHMAN: Virtually everybody who is here has either witnessed or been involved in a number of these sponsored trials: three on CNTF, two on riluzole, two on BDNF, one on gabapentin, and one on IGF-1. All these trials have been driven by the industry. In most cases, trial designs differ from one another; they are not comparable. As a rule, data are managed by the company, not by the investigators who eventually get to see it, although somewhat after the data have been released by the Wall Street Journal to stockholders (which is required by law) or by press conferences. This has caused some problems; the data have been presented in other than a strictly peer-reviewed scientific manner.
Another issue is that of combinations. If there are two drugs, you may wish to compare A with A plus B, and B with A plus B. …
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