Have been in touch with Rachna for the last few weeks as we discussed issues with one of the #Bhopal #clinicaltrials site for #Covaxin. Lots of issues with trial conduct as documented in her thread below.
Issues with informed consent, care of trial participants, recruitment.
This issue needs to be highlighted more as it shows us what poor oversight could mean, especially because we are now talking about expanded use of vaccines "in clinical trials mode" (not that I am sure anyone really knows what that means)
Now this is probably just an issue with an inexperienced trial site and investigators who were eager to be part of a prestigious study, but faltered on some aspects of trial conduct. But imagine this happening at scale-- how are we going to ensure protection of the vaccinees?
Specifically what were the issues with this trial site:
a) some poorer communities around the trial site were approached for recruitment, with a promise of INR 750. Potential participants often apparently herded in buses to trial site.
b) some participants do not seem to understand that they were in a clinical trial. Told you are getting vaccinated-- get it now for free.
Issues with (adequate) informed consent, copies of consent forms not provided.
c) some participants who reported with adverse events post-vaccination allege that they were asked to get investigations done of their own and purchase medicines.
(when they should have been provided medical care)
d) consent taken apparently in some instances post-facto after vaccination was already done.
This issue has been covered today by NDTV. Hope other journalists will explore how clinical trials are happening at other sites (FOR ALL VACCINE CANDIDATES).
We owe it to our trial participants to ensure proper trial conduct
(e) Continued from earlier in the thread.
Some clinical trial participants are apparently now complaining that when they reported with health complaints after vaccination, there trial related papers have been taken away from them,& they are also not getting proper medical care
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