ThriftyCents, The study is double-blinded (neit
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Posted On: 05/14/2020 7:28:40 AM
Re: thriftycents #33924
ThriftyCents,
The study is double-blinded (neither the participant nor the center knows during the trial which participants receive Leronlimab).
Also, I don't believe a Data Monitoring Committee (DMC) has been stablished. These are normally set up for high-risk drugs (basically to monitor SEAs and stop the trial if things get out of control). As per FDA:
In some adaptive trial designs it is possible to have an early peek at the data, and this is normally agreed before starting it (not always). However, it is not CYDY who can access the data but the commitee. The company can receive the data from it but there are regulations about disclosing it as well.
This is a short trial and I personally don't believe that there is need to have a look before everything is said and done; also, most of the companies prefer the full set of data as normally this helps with the statistics (if the drug works). Besides this 75 patients with a placebo group is alrady a small number of patients.
Not sure if Nader knows something we do not, and whether due to the extraordinary circumstances FDA has relaxed the rules and will allow an interim (this costs money to CYDY by the way), however imo, a couple of weeks wait is not a big deal. At the end, we will receive a beautiful p-value.
The study is double-blinded (neither the participant nor the center knows during the trial which participants receive Leronlimab).
Also, I don't believe a Data Monitoring Committee (DMC) has been stablished. These are normally set up for high-risk drugs (basically to monitor SEAs and stop the trial if things get out of control). As per FDA:
Quote:
DMCs are generally recommended for any controlled trial of any size that will compare rates of mortality or major morbidity, but a DMC is not required or recommended for most clinical studies. DMCs are generally not needed, for example, for trials at early stages of product development. They are also generally not needed for trials addressing lesser outcomes, such as relief of symptoms, unless the trial population is at elevated risk of more severe outcomes
In some adaptive trial designs it is possible to have an early peek at the data, and this is normally agreed before starting it (not always). However, it is not CYDY who can access the data but the commitee. The company can receive the data from it but there are regulations about disclosing it as well.
Quote:
Knowledge of unblinded interim comparisons from a clinical trial is generally not necessary for those conducting or sponsoring the trial; further, such knowledge can bias the outcome of the study by inappropriately influencing its continuing conduct or the plan of analyses. Unblinded interim data and the results of comparative interim analyses, therefore, should generally not be accessible by anyone other than DMC members or the statistician(s) performing these analyses and presenting them to the DMC.
This is a short trial and I personally don't believe that there is need to have a look before everything is said and done; also, most of the companies prefer the full set of data as normally this helps with the statistics (if the drug works). Besides this 75 patients with a placebo group is alrady a small number of patients.
Not sure if Nader knows something we do not, and whether due to the extraordinary circumstances FDA has relaxed the rules and will allow an interim (this costs money to CYDY by the way), however imo, a couple of weeks wait is not a big deal. At the end, we will receive a beautiful p-value.
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