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New Delhi: The Modi government has allowed deviation from protocol in clinical trials in light of the disruptions caused by the Covid-19 lockdown, ThePrint has learnt. Companies and laboratories conducting the trials, however, will have to convey the protocol tweaks to the government.

The order was conveyed to pharmaceutical majors through a notice issued by the Central Drugs Safety and Control Organisation (CDSCO) Monday. In the order, accessed by ThePrint, the government has said the trials underway may also be reconsidered, suspended or terminated.

In the notice, India’s apex drug regulator seeks to acknowledge the fact that “various challenges may arise during the conduct of clinical trial in the wake of outbreak Covid-19 in the country”. 

The restrictions imposed to check the spread of Covid-19, the notice says, may impact “recruitment of trial subjects, laboratory testing, diagnosis, administration of investigational product, reporting of severe adverse effects, scheduled visits, assessment of safety and efficacy parameters among others”. 

“In some cases, protocol amendment, deviation, modification in the procedures may be necessary due to unavoidable circumstances,” it says.

Signed by drug controller general of India V.G. Somani, the CDSCO notice says the protection of trial subjects’ “rights, safety and well-being” is of paramount importance. 

“In case of ongoing trial, the sponsor in coordination with the investigator and the respective ethics committee should decide whether to continue the trial or otherwise in the interest of the trial subject.”

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‘The move is important’

For every clinical trial, pharma companies have to devise a protocol, or set of conditions that the exercise must comply with, in consultation with the government.

According to data by Center Watch, a website that serves as a global database for clinical trials, there are more than 2,500 active trials underway in India for drugs aimed at patients suffering from cancer, hepatitis B, muscular dystrophy and gestational diabetes, among other things.

Experts have described the government’s move as “important”.

“The move is important as, under such circumstances, several trials need to be suspended or terminated,” said Amar Jesani, public health expert and editor of the Indian Journal of Medical Ethics.

“For instance, during the 21-day lockdown, many patients may not be able to visit the hospital for the trial and it may impact the process of data collection and analysis, deteriorating the purpose of trial,” he added.

Asked what a protocol deviation may constitute, Jesani offered the example of an “educational trial on school students” that was underway when the lockdown kicked in. 

Due to the extended school break, he said, the students were no longer available for the study, adding that the researchers may now plan to visit the house of each child to continue the trial. “Similar situations will arise in drug-based trials,” he added.

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US FDA has taken the same decision

The government’s move comes close on the heels of a similar decision taken by the US health regulator, the Food and Drug Administration (FDA), on 27 March.

In the US, Covid-19 has been declared an emergency.   

“Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with Covid-19,” the FDA said in its order. 

“These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory, diagnostic testing,” it added, saying the FDA recognises “that there may be unavoidable protocol deviations due to Covid-19 illness and/or Covid-19 control measures”.

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