(f) continued from earlier in the thread.
The recruitment ad (which was also published in local newspapers) suggests all trial participants would be benefited- not sure how that can be committed to? (we do not know in trials in advance)
(also not sure why Aadhaar card)
The recruitment ad (which was also published in local newspapers) suggests all trial participants would be benefited- not sure how that can be committed to? (we do not know in trials in advance)
(also not sure why Aadhaar card)
(g) to clarify an earlier point, the site being inexperienced could be a factor, but that does not make it a lesser protocol violation, and a serious ethics and regulatory lapse
(h) it also shows poor oversight by the sponsor and regulator. The sponsor employed CROs I think so what were they doing?
And if this is going to play out at a larger scale in trial mode, that is even more worrying
And if this is going to play out at a larger scale in trial mode, that is even more worrying
(i) also important to remember that if the participant is vulnerable (illiterate and those from impoverished backgrounds would be included), then audio-visual consenting is required. Was this done-- if yes, this should be audited by the regulator/sponsor and co-sponsor.
(j) Incidentally, the co-sponsor in this case is @ICMRDELHI which is tasked with promulgating #researchethics guidelines in the country.
Reporting on this issue
vice.com/en/article/bvx…
vice.com/en/article/bvx…
(K) interestingly, Bhopal has two sites for the clinical trial. One in the public sector which is a famous and old government medical college hospital. That has struggled to get even 100 participants from what I hear.
(L) The second, a private medical college hospital which has managed to get around 1700 participants recruited from what I hear.
Same city. Two sites. Two majorly different recruitment numbers reached.
What explains?
Was recruitment done differently l?
Same city. Two sites. Two majorly different recruitment numbers reached.
What explains?
Was recruitment done differently l?
Now it is for due process which should be transparently done for causality assessment as per the NDCT Rules. But should the family of the deceased have been abandoned in this manner?
And why was this SAE -a death in a Covid19 vaccine trial- not reported in the public domain??
And why was this SAE -a death in a Covid19 vaccine trial- not reported in the public domain??
Given all the problems with how the trial has been run at this site, as documented by multiple sources above, with issues with informed consent, due medical care to trial participants, issues with recruitment, and now this SAE, this ends up being a very troubling pattern
Dainik Bhaskar in Bhopal reporting the SAE- a Covaxin clinical trial participant's death. Death happened on 21 December but details only emerging now. Why was this not in the public domain?
What kind of regulatory steps are being taken as part of NDCT 2019?
What kind of regulatory steps are being taken as part of NDCT 2019?
ToI Bhopal does a much smaller story on the same issue
Anoo has been in Bhopal and documenting some of the issues involved
https://twitter.com/AnooBhu/status/1347799296540741632
Let's look at the SAE reporting timelines in India-- as per our regulations-- the NDCT Rules 2019
Source (cdsatoolkit.thsti.in/safety-managem…)
Source (cdsatoolkit.thsti.in/safety-managem…)
This means that if the death happened on 21 December 2020, and the investigators knew, they would have informed the ethics committee, sponsor, regulator within 24 hours.
Within 14 days, an initial analysis needs to be provided to ethics committee, Head of Institution, DCGI
Within 14 days, an initial analysis needs to be provided to ethics committee, Head of Institution, DCGI
Then how did the regulator make an announcement that the vaccine candidates were "110% safe" on 03 Jan 2021 when presumably the causality assessment report was not yet available to it (but the incident had been reported)-- and if it was- kindly put it in the public domain.
Apparently audio visual consent has not been taken for trial volunteers from vulnerable backgrounds. That is a clinical trial rules violation, a major one at that. Why was this not caught by the sponsors, the site monitors, the CRO involved, the ethics committee, etc
Can the ethics committee please stand up? Where is it? How have they been monitoring the trial?
Did they provide approval to the recruitment ads used at the site? The methods used by the investigators?
Were they aware of the consent violations? Where is the AV consent trail?
Did they provide approval to the recruitment ads used at the site? The methods used by the investigators?
Were they aware of the consent violations? Where is the AV consent trail?
Sponsor is supposed to know within 24 hours of SAE being known. ICMR is a co sponsor of the Covaxin trial.
Are they investigating now when SE happened on 21 December, or have they been investigating? Reports?
Are they investigating now when SE happened on 21 December, or have they been investigating? Reports?
https://twitter.com/Iam_Ayushmann/status/1347853623150186497?s=19
And while we are at it, is the causality assessment for the SIIL trial SAE in Chennai over? Where is that report? Why is that also not in the public domain?
And now reports coming in the dean of the trial site has resigned today
One of the co sponsors BB has issued a statement
https://twitter.com/Iam_Ayushmann/status/1347884956454969345?s=19
What is interesting about above is BB claims the site knew about SAE. No one apparentky from site bothered to visit the family. Though they called post SAE
But Dainik Bhaskar report today indicates family still received a call yesterday, Friday, to remind about due second dose.
But Dainik Bhaskar report today indicates family still received a call yesterday, Friday, to remind about due second dose.
The MP govt constituted a committee today to look into this issue-- formed today and also gave its report today-- basically saying site followed protocols as per their judgment. But nothing on causality, etc.
h/t @hksoni2003
h/t @hksoni2003
The Gandhi medical college where this committee was constituted is also a trial site for the Covaxin clinical trial, which is a conflict of interest by itself
bhopalsamachar.com/2021/01/mp-new…
bhopalsamachar.com/2021/01/mp-new…
A reminder that the deceased clinical trial participant was a tribal. Tribals are considered a vulnerable population for research purposes in India as per the ICMR 2017 research ethics guidelines
Curiously, the Gandhi (Govt) medical college at Bhopal which was a site for the #COVID19 #vaccine #trial for Covaxin has disappeared from the CTRI entry for Covaxin.
Heard that many phase 3 trial participants were recruited there- what happened to them?
ctri.nic.in/Clinicaltrials…
Heard that many phase 3 trial participants were recruited there- what happened to them?
ctri.nic.in/Clinicaltrials…
This is still a live ad for the Gandhi Medical College as a trial site on the college website
gmcbhopal.net/pdfs/Adv%20stu…
gmcbhopal.net/pdfs/Adv%20stu…
(From Nov 2020)
Gandhi medical college, peoples university to be part of Covaxin trial
timesofindia.indiatimes.com/city/bhopal/ga…
Gandhi medical college, peoples university to be part of Covaxin trial
timesofindia.indiatimes.com/city/bhopal/ga…
(also from Nov 2020)
COVID-19 vaccine: Bhopal's GMC gets ready for Covaxin trials
businessinsider.in/india/news/bho…
COVID-19 vaccine: Bhopal's GMC gets ready for Covaxin trials
businessinsider.in/india/news/bho…
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