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Old 08-02-2017, 09:41 AM
Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
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Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
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Quote:
Originally Posted by jeffreyn View Post
re: "will be completed in July 2020"

I noticed that too, and it's a similar end-date for the MJFF et al. trial.

Maybe it's based on an expected slow recruitment process? All the more reason to get these announcements and articles spread around the PwP communities and forums.
The trial timeline projects a 6 month recruitment time for each Cohort, which is fairly standard for a 75 member study. In actuality, the expectation is that it should be faster, not slower. This is due to several factors, most notably the significant amount of publicity associated with the drug and the trial. Also, as opposed to the GU trial, there will be 25 site locations across the U.S. So, each site only needs to average 3 volunteers. The main factor for the the three year timeline is that this is actually two separate trials with Cohort 1 (moderately advanced patients) and Cohort 2 (recently DXed patients). Cohort 1 is for 6 months and Cohort 2, which will begin after the first one is completed, is for 12 months. With statistical analysis and recruitment time, that all adds up to about 3 years.

I do agree, we should all get the word out about the upcoming trial recruitment and cut the 6 month time down to one month. If that happens with both cohorts we can cut almost a year off of the study time.
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"Thanks for this!" says:
eds195 (08-02-2017), jeffreyn (08-02-2017)