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Ask the Doc: Q & A with Edward Kasarskis, MD, PhD

Edward Kasarskis, M.D., Ph.D. is Director of the multidisciplinary ALS Center at the University of Kentucky Neuroscience Center in Lexington, Kentucky, professor in the Department of Neurology at the University of Kentucky, and Chief of Neurology at the VA Medical Center in Lexington KY. 

    Dr Kasarskis
    Dr. Kasarskis

Are There Limitations on Joining Clinical Trials?

Q: I recently learned that people with ALS who were diagnosed a year ago or longer are not eligible for clinical trials. Why would that be?

A: All clinical trials have a set of specific selection criteria for participants. Sometimes they are related to the individual’s disease and often the criteria are related to age, gender, and distance to the study site. It all depends on the particular study and what features have to be “ruled out” to be sure they won't affect the outcome of the study.

One of the challenges in enrolling people with ALS in a clinical trial is that just getting diagnosed typically takes about a year on the average. It usually takes about 9 to 12 months to diagnose someone with certainty, and the minimum time it takes to be diagnosed is usually 6 months.

With ALS, there is a fairly narrow window for recruiting clinical trial participants depending on the study. You have to know for sure that the potential trial participant has ALS, so practically speaking, it is almost impossible to enroll an ALS patient who has the disease for only 3 months. At the other extreme if researchers are studying a drug that involves measuring the progression of ALS, they may not accept volunteers who have had the disease for 9 to 12 years. That’s because this person with a slowly-progressing form of the disease probably won’t have measurable changes during the normal course of a clinical trial.

Sometimes people are not accepted into clinical trials for other reasons. For example, we’ve had studies that involved measuring a patient’s changes in breathing status. But if someone with ALS has their breathing at 100% of normal, they might not be able to join the trial. We’ve also been involved in a study that was measuring muscle fatigue; some people could not participate because they didn’t have enough strength to hold the “grip dynamometer” which was used to monitor changes in muscle power.

So the bottom line is that each clinical trial is different and each has their own set of rules (entry criteria).


If you would like to submit questions for a future Q & A, please send your questions to theexchange@alsa-national.org. Please understand that we won’t be able to address all questions and we won’t be able to respond to individuals personally.

 

 



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