March 02, 2021

Lesson from the pandemic – the value of large-scale clinical trials

The speed and scale of the Covid-19 pandemic was surprising, Dr Gagandeep Kang, the

country’s foremost vaccine expert and professor of microbiology at the Christian Medical

College-Vellore, told Anonna Dutt. She said India needs to invest in creating clinical trial
networks to prepare for future pandemics.
 
Did you imagine the emergency would be this big when we started seeing the first few
cases?
 
All through March (last year), I was getting increasingly worried that it wasn’t something that
was being taken seriously. What surprised me was the speed and scale of the spread. It moved
much faster than I anticipated. And that I think is reflection of the reproductive number. We
probably underestimated it early on because we were relying on Chinese data. We got a better
handle on it when we started getting data from Europe.
 
Was it also because we were looking at data from the SARS outbreak?
 
The difference between SARS and Sars-CoV-2 – the good thing is it does not kill as much as
SARS does. The SARS case fatality rate was close to 10%. Only 8,000 people got infected but
almost 800 of them died. Whereas with Covid-19, we are having trouble what the case fatality
rate is. It looks like among the symptomatic, it is one in 100. But there are so many people
without symptoms that the infection fatality rate is lower than 1%. Sars-CoV-2, however, is
more transmissible because of asymptomatic infections.
 
What are the policy implications of this difference between Covid-19 and SARS?
 
In January (last year), we saw that they (the viruses) were similar. Initially, theWHO and China
were saying that there was no person-to-person transmission, which was quickly discounted by
the third week of January. Then, they were also saying that there were no asymptomatic
infections. And, that was something I was waiting for. Because, once you have a disease that
can spread asymptomatically, your methods for controlling the disease need to change
completely.
 
Towards the end of February, it became clear that this was happening and it could not be
handled the same way as SARS had been. All of the initial recommendations of hand-washing
and social distancing came from our understanding of SARS. But, asymptomatic infection is
when masks enter the picture and become even more important. Now we also know that it is
not just a droplet infection, you produce aerosols as well.
 
Was the lockdown necessary?
 
If we had a situation where everybody followed government instructions, then there would
have been no need for a lockdown. Countries such as Vietnam, Thailand, and Japan have all
shown that it is possible to manage without the lockdown as long as you have the resources,
the ability and the commitment. I think the lockdown was necessary because it conveyed to the
people that it is a serious issue and it stopped the movement of people. It also had many
unintended consequences like what happened to livelihoods, what happened to migrant
workers. It also created a fear in the minds of people, leading to stigmatisation.
 
I was really worried about the government-controlled testing of Sars-Cov-2. When they set up
testing in January, it was only NIV doing the testing, only NIV confirming it. And, that is
impossible for a country the size of India. Private labs were not even allowed to establish testing
until the end of March with the lockdown. So, you say you can start the testing now and you
lock the country down when all the kits are imported. Fortunately, testing has opened up.
All kinds of things were done which were a waste of effort and a divergence from the critical
issues like ramping up testing as quickly as possible. If the lockdown had been a lockdown
where imports were still allowed, it would have been better. I think now the government is
clear that it does not want to be caught in that situation. Diversification of the supply chain is
definitely something we should be thinking about.
 
What do we need to do to prepare for a future pandemic?
 
The one thing that we should learn from this pandemic is the value of large clinical trials. If
you go to the clinical trials registry of India, currently, there are hundreds of trials for different
drugs registered. All of them are recruiting just about 100 patients. If you take a tiny number
of people, you have a bad study design, you know what you what to prove, and guess what,
your study actually proves what you want it to.
 
We need to create clinical trial networks for drugs, vaccines, and procedures not just for
infectious diseases, but cancer, orthopaedics, cardiology and so on. We should fund one large
study rather than 30 smaller studies.
 
Then, there is surveillance. We need “one health” surveillance looking at both animals and
humans. It can be done separately but the data needs to be shared. There is a need for an
integrated data system.
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