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  • 1.  WHO Solidarity Adaptive Clinical Trial for COVID-19

    Posted 04-16-2020 15:26
    The WHO Solidarity clinical trial of therapeutics for COVID-19 is described as adaptive with the interim examinations by a Global Data and Safety Monitoring Committee.  This study could be very important.  The statistical details of clinical trials are critically important for valid results.   Are the charter and membership of the monitoring committee public?  Is the statistical analysis plan public so it can be reviewed?

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    Alan Forsythe, PhD
    ASA Fellow and Lifetime Member
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  • 2.  RE: WHO Solidarity Adaptive Clinical Trial for COVID-19

    Posted 04-17-2020 09:41
    ​These are good questions.  The make-ups of DSMBs are usually privately held. They need independence from the investigators. Its charter is generally public record, and the protocol itself has to be registered in a trial registry so indeed we have the capability to review the design if the registration is properly completed, which I suspect it was.

    Speaking of solidarity with WHO, is anyone coordinating a statistician protest of US defunding aid to WHO? How absurd is that ii the midst of the COVID-19 crisis?

    Best to all,

    Jon

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    Jon Shuster
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    Original Message


  • 3.  RE: WHO Solidarity Adaptive Clinical Trial for COVID-19

    Posted 04-17-2020 12:37
    Jon, perhaps you can help me locate the documents with specific links.  I went through the EU clinical registry and the WHO Blueprint for the Solidarity study and did not find sufficient details.  I do not need the specific names of the Steering Committee or the DSMB but their anonymized credentials would be appreciated.
    Thank you.

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    Alan
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    Original Message


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