India’s health research agency has launched a project to create a database of coronavirus disease patients and their clinical records, four months after conceiving the idea and amid concerns in medical circles about a dearth of Covid-19 research in the country.
The Indian Council of Medical Research on Thursday announced the project to establish a National Clinical Registry of Covid-19, containing details of the clinical course of the disease in the patients, their lab investigations and treatment protocols, and the outcomes.
The council has named 15 medical colleges, including AIIMS, New Delhi, and the Institute for Postgraduate Medical Education and Research, Calcutta, which will “mentor” hospitals across the country that have been invited to contribute to the registry.
Data from the registry are expected to serve as a tool to help improve treatment strategies and predict the disease severity and outcomes, the ICMR said.
The project had first been proposed in early April by the ICMR’s Covid-19 clinical research group.
The council has issued a “letter of intent” inviting hospitals from across India to join the registry, which will require them to upload their patients’ clinical records in a standard format onto an electronic platform.
The ICMR said the data would be used to generate weekly epidemiological and clinical reports, formulate treatment protocol, develop policy guidelines for decision-making, understand the predictors of disease severity, and examine India-specific issues such as Covid-19 among tuberculosis patients and malnourished populations.
The data will also be used to probe the variations, if any, in the clinical features of the disease in India compared with other countries.
Hospitals that receive at least 100 Covid-19 patients a month will be eligible, the council said. The data in the registry will be analysed by the council’s own researchers as well as other health researchers, who would need to send in their proposals.
“The proposals for accessing the database for research will go through an established system of a screening committee,” Samiran Panda, a senior scientist and head of the council’s epidemiology and communicable diseases division, told The Telegraph.
The project comes against the backdrop of concern among some health experts that India has not generated enough original clinical research on Covid-19 although its coronavirus count has crossed two million, with over 1.3 million patients recovered and over 41,500 deaths.
India on Friday recorded 62,538 new Covid-19 cases, a fresh single-day high, raising the total number of lab-confirmed cases to 2,027,074, of whom 607,384 patients are under medical supervision, 1,378,105 have recovered and 41,585 have died.
“Our numbers are our great advantage — the longer we delay such initiatives, the longer we’re missing opportunities to generate information that could guide policy or treatment,” said Oomen John, a public health specialist at The George Institute for Global Health, New Delhi.
When the number of patients is large, he said, it is easier to pick up “signals” that might not be detectable among smaller groups of patients.
“Suppose, there is an association that occurs once in 10,000 patients. It’s easier to pick the 10 signals from 100,000 patients,” John said.
Detailed analyses of disease severity and mortality, for instance, among hospitalised patients could help yield insights into which subsets of patients within specific age groups or specific categories might be at high risk of severe disease or death, John said.
A registry that consolidates clinical records of patients from around the country is a “good step in the right direction”, said Anant Mohan, a senior critical-care specialist at the All India Institute of Medical Sciences, New Delhi.
Mohan and his colleagues at AIIMS had last month generated one of the few papers from India on Covid-19 patients. Their study had found that an overemphasis on fever as a symptom might lead to missing cases or delayed diagnosis.
But this isn’t India’s first proposal to build a database of Covid-19 patients. Earlier this year, a private health research organisation and the Institute of Genomics and Integrative Biology, a unit of the Council of Scientific and Industrial Research, had proposed a 100,000-patient database.
However, for multiple reasons, that proposal has not evoked the level of response that its proponents had hoped to receive. “In many hospitals, doctors are overwhelmed by patient care. Besides, much of the clinical records are on paper, and under a lockdown we couldn’t even send people to access patients’ records,” said a senior clinician-researcher associated with the project.
