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In
an effort to keep you apprised of the research activities here at the
Center, I would like to share with you our plans for an ALS scientific
conference next Spring. The goal of the conference is to bring together
ALS experts and young investigators to brainstorm on the future of clinical
trials in ALS.
As you are aware, clinical
trials of all potential ALS drugs in the past decade, other than riluzole,
have failed to show efficacy for the disease. Current rapid progress in
translational research is likely to make an increasing number of novel
therapies available for clinical trials in ALS in the near future. Thus,
ALS clinical trialists must be prepared to conduct much more effective
and efficient protocols. A scientific meeting would be the best way to
comprehensively address the future of ALS trials.
The goals of the meeting are, first, to expand the knowledge base as regards
clinical trials for both experienced and future clinical trialists in
ALS; second, to generate new clinical trial designs through discussion
of controversies, new ideas, and new directions; and third, to evaluate
the current collaborative study groups and examine new ideas for a national
collaborative study group for ALS.
Throughout the meeting we will
focus on issues regarding translational research that is producing novel
therapies, current issues in clinical trials in general, and lessons from
trials in diseases other than ALS. Detailed sessions will be held to focus
on 6 topics crucial for developing effective, efficient future ALS trials:
1) problems in defining the natural history of ALS, 2) selecting primary
outcome measures, 3) protecting patients and preserving trial quality,
4) study designs and aims, 5) emerging surrogate markers, and 6) drug
combination trials. Finally, we will try to gain more understanding of
the need or feasibility of national and regional research groups as effective
collaborative structures.
The proposed meeting will be
the first scientific meeting in ALS clinical trials, providing an unprecedented
opportunity to discuss issues that must be resolved so that clinical trialists
can conduct more effective and sophisticated trials, to make the best
use of advances in translational research, and to create the greatest
opportunities to identify effective new drugs in ALS. The meeting will
be sponsored in part by the MDA and will also involve Columbia’s
celebration of Lou Gehrig’s 100th birthday.
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