The Indian Council of Medical Research (ICMR), in collaboration with the Health Ministry and All India Institute of Medical Sciences, plans to roll out a project to create a rigorous database of Covid-19 patients admitted in hospitals across the country in an effort to understand how treatment can be improved.
The project, a national clinical registry, will also serve as a crucial platform to conduct clinical trials to study the effectiveness of newer therapies being used as part of treatment for this disease.
Around 15 institutions are expected to help create this network and get hospitals and medical colleges on board as part of the exercise, which is awaiting clearances from a common ethics committee of the ICMR.
“We are starting a clinical Covid registry wherein 15 mentor institutions (across the country), which are institutes of national importance, will be helping us. The purpose of these mentor institutions is to encourage other hospitals and medical colleges to participate,” ICMR Director General Dr Balram Bhargava told The Indian Express.
“We have data at the Ministry of Health, we have data at ICMR in terms of testing, but we would like to have hospital data so that we can get a perspective of what has happened to these patients and what is the progress. We have to get ethical clearance for this… it is a work in progress,” he added.
The registry will be actively rolled out “as a priority”, said NITI Aayog member Dr V K Paul, who is also the chair of the Covid-19 National Task Force that first recommended this registry as part of its goal to promote research.
“The whole idea is that we create a network of institutions that are looking after Covid patients of various severity and from various parts of the country. The experience gained from this clinical enterprise and clinical work, collected in a systematic, structured, scientific way on a large set of variables, (would then be) available as a repository or database,” he told The Indian Express.
“There is a team of clinicians, scientists, analysts and biostaticians who will run it. It will be a very vibrant (registry)… it is for a national cause (collecting this data). We will use it for understanding this disease and to learn to make better decisions,” he said.
According to him, “more than a hundred” hospitals are expected to take part in the exercise. “Centres of excellence have been identified, who will then create a sub-group like one of those hub-and-spoke models,” he said.
The purpose of the database is to help understand the disease and the factors that cause adverse outcomes. It is also to understand how the same determinants may affect people based on other factors.
“The purpose is to understand the disease, to understand its determinants… why adverse outcomes happen, what therapies work or don’t work,” said Dr Paul. “Some (patients) die, some don’t die. Those who died, what was wrong with them? Is it genetic? Is it environmental?… Is it certain body elements?” he said.
One way the registry is expected to do this is by providing standard demographic data like mortality rates specific to the sex of the patient and mortality by time. However, it would also collect other types of data that may help healthcare workers understand what interventions may help them improve the survival rates of their patients. This includes testing the effectiveness of newer therapies by using the database as a platform for clinical trials.
“This will be a platform where, already, (we are) recording a thousand data points. Say, you have a new drug… We can choose which group to give it to (based on the data points),” said Dr Paul. “Tomorrow, we can say, if I add drug ‘x’ at this stage, will it make a difference?”
Another important purpose the registry is expected to serve is to collect data on how other approaches like changing the posture of the patient or providing oxygen at a certain time would help improve outcomes.
“For example, if the secondary infection rates are high, can we change that by doing certain things, which is not a trial in a trial sense, but is just a quality improvement pathway?” he said.
“For quality improvement studies, clinical studies and hardcore clinical trials, this becomes a platform in addition to a database which makes us understand the disease, the disease dynamic, its determinants and… the pathophysiology. And, on (all that data), do studies. That is the vision,” he added.
ICMR to host symposium with international experts
New Delhi: In a multi-country symposium with Dr Anthony Fauci, top infectious disease expert in the US, and other major international experts, the Indian Council of Medical Research will host discussions and presentations on “Novel Ideas in Science and Ethics of Vaccines against Covid-19 pandemic” on Thursday.
A series of sessions, beginning at 4.30 pm, will explore “Timely & safe — towards a Covid-19 vaccine”, “Novel ideas in vaccine development, rollout, and adopting emerging evidence in pandemic situations”, and “The ethics of different development approaches — Equity of participation in development & Community engagement and consensus”.