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loanranger

05/01/21 8:16 AM

#357686 RE: Minnesinger #357682

Good point. It doesn't help that we need to translate the sources from Russian...both translate to "quantity/ number of patients". Neither distinguishes between enrolled, randomized or participating.
One still says 106.
https://clinline.ru/reestr-klinicheskih-issledovanij/705-17.12.2020.html

The other 138.
http://grls.rosminzdrav.ru/CiPermitionReg.aspx?PermYear=0&DateInc=&NumInc=&DateBeg=&DateEnd=&Protocol=IPI-BRIc-201&RegNm=&Statement=&ProtoId=&idCIStatementCh=&Qualifier=&CiPhase=&RangeOfApp=&Torg=&LFDos=&Producer=&Recearcher=&sponsorCountry=&MedBaseCount=&CiType=&PatientCount=&OrgDocOut=2&Status=1%2c2%2c3%2c4&NotInReg=0&All=0&PageSize=8&order=allpatient&orderType=desc&pageNum=1

CT.gov says "Estimated Enrollment : 120 participants"

Not to mention that there are a few different counts for recruitment sites (if that's what they are):
https://clinline.ru/reestr-klinicheskih-issledovanij/705-17.12.2020.html says....
"Number of medical institutions....twenty"
...but lists 18.

The "grls" website lists 20 locations on its
"List of medical organizations in which clinical trials are supposed to be carried out".

CT.gov lists 11 Russian Federation locations.



Hopefully it'll all come out in the wash in the form of updates to clinicaltrials.gov.



ps. The original 106 patient count on the Russian site suggested 14 US patients. Does the new 138 patient count suggest a total count of 152?
I don't expect full clarity from it, but I believe the ct.gov site will be updated soon given the latest PR. Rules say:
"Responsible Parties should update their records within 30 days of a change to any of the following:
Recruitment Status and Overall Recruitment Status data elements on ClinicalTrials.gov"

The Locations section is one of those elements.