Thread by @AnantBhan

This is a letter which has been sent out by the ICMR DG yesterday. Now that multiple folks have confirmed genuineness, let me raise some issues with this letter on #vaccine #trials during a pandemic, in this case #COVID19
What are the ethical issues in this letter? Read on.

For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July?
And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided?

How were the clinical trial sites mentioned in the appendix chosen--on what criteria? eligibility? From what list? was this selection done by ICMR or by BBIL? Some of these seem to be small nursing homes/hospitals- are they the apt place to run a pandemic #vaccine trial?

Let's come to the tone of the letter. This reads more like a threat than a letter. "Get everything done by 07 July (in a letter dated 02 July) and start clinical trial participant recruitment"
Other wise non-compliance will be viewed seriously? By whom? by ICMR? under what power?

Does this mean all these 'institutions' have to follow all due processes to enable this trial to be run within 5 days from the letter? Including ethics committee approvals? Is that not undue pressure on the institution and committees?

As per this news report, approval for phase 1 and phase 2 studies have been granted. Which of the institutions in the list are going to run phase 1 studies-- safety studies-- which require a lot of precautions/risk management.
expresspharma.in/covid19-update…

letter uses term 'subjects' for clinical trial 'participants'. The ICMR's own ethics guidelines have moved on to use more ethically acceptable term 'participants' rather than subjects.
Subjects used typically by pharma in regulatory studies.
Is this letter written by BBIL?

Can someone also check if ALL of these are sites which have ethics committees registered with CDSCO?
which have done some kind of vaccine trials before?

Just found the CTRI Entry on this trial
ctri.nic.in/Clinicaltrials…

Trial registered on 01st July 2020 for phase 1 and phase 2 study. And we will have efficacy data by 15th August to announce a launch for public health use?

Ethics committee approval status for this trial as of today on CTRI

CTRI entry says the date for first enrolment into the trial would be 13 July 2020 BUT the ICMR letter required trial enrolment to start by 07th July 2020

To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries.Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process

I have been alerted to the fact that ICMR has issued a press release today on the issue of the letter.

Ok, back to the study. The CTRI entry was amended today (perhaps by the sponsor). Can happen with CTRI entries.
Not sure what the amendment was though

Pay close attention to the time-points for the phase 1-phase 2 studies

I am a bit curious as to who is the overall (scientific) principal investigator for this multi-site clinical trial?
Should it be the sponsor of the study (BBIL)?
Is that not a conflict of interest?

Remember, ICMR is a source of the vaccine strain (though the National Institute of Virology in Pune, an ICMR member institution).
So of course ICMR as a co-creator of the vaccine is also having a conflict of interest in this study.

So then, what exactly is the role for ICMR in this study? They are not the Principal Investigator or trial coordinator (the sponsor- BBIL- is listed for that).
None of their institutions are in the trial sites as well

In what capacity was then the letter sent out by the ICMR then originally-- they are not the sponsor, not the trial coordinator/principal investigator (ICMR staff), not a trial site.
They are a co-creator of the vaccine.
Should they be writing to sites directly?

So in what capacity exactly is ICMR expecting to expedite the clinical trials for the vaccine?
they are not the sponsor, not the trial coordinator/principal investigator (ICMR staff), not a trial site. They are not the regulator (CDSCO/DCGI is)

The Indian Academy of Sciences @IAScBng has put out a press release today expressing concerns on the letter issued by ICMR