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Thread: For those who understand spanish (Dr. Vaquero)

  1. #301
    Quote Originally Posted by lunasicc42 View Post
    GRAMMY, I have the feeling that this question has been discussed before but I forget, if so
    But what is the reason that it's so long between the completion date on a site such as listed on clinicaltrials.gov and the date in which the publication is actually available for all to see... Like I always used to look at the completion date listed on the clinicaltrials website and think: "ok, that is the approx date that we will hear news or results of such trial", but then I always end up feeling like a gullible doe-eyed sucker because the end date listed almost never correlates to getting information on the the said trial

    Things you need to click on and read at the trial site to follow along are some important "historical changes" and what is the Primary Outcome (which is most important) and then read through the Secondary Outcome to see what they hope to have tested on their subjects. They really did ramp up the amount of data they wanted to gather and publish on their patients. From baseline to final follow up is 24 months for all arms of the trial.

    With this Ph 2 trial, they posted it with a start date of 7-2015 without a known patient number and an estimated completion of 5-2017.

    Then they show the trial next started October 7th, 2015 with a patient number of 10.

    It is considered Day 1 for each patient the first day of the first cell administration. The remaining 2 doses will be administered at intervals of 3 months from the first administration (of the treatment period after, months 4 and 7). At the end of the study will be performed a full assessment of the variables collected along the study trial. The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum duration of the follow-up period for each patient is 10 months after the first administration.

    On November 12th, 2015 they've settled in on a more definitive primary outcome goal and they are added to the trial.

    On June 13th, 2016 they change the status from recruiting to active (not recruiting) and enrollment from anticipated to actual.

    On September 6, 2016 they added the secondary arm of investigation to the trial in addition to saying the trial results would be submitted to the Spanish authorities and they will publish in a scientific journal.

    On August 27th, 2017 the regulating authority was moved from the Spanish Agency of Medicine to the FDA drug and device and potential export status. Data will be submitted to the CTD of Spain. Anonymized individual data of participants will be shared with Authorities at the end of the Clinical development plan by the CTD (Common Technical Document). Results will be published in a scientific publication. Time Frame: Starting at CTD submission to authorities.

    Depending upon the journals publication time frame and required edits from the publisher, it can add to the time frame when it actually comes out to the public. I personally believe the time to be around 6 months for many journals but that can vary quite widely for various reasons and the journals a study is submitted to. For instance, Phase 1 ending to journal appearance was 17 months. (Even that time frame isn't terribly unusual.)
    Last edited by GRAMMY; 01-27-2018 at 02:54 AM.

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