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datamatixOP•

Jammi Nagaraj Rao, a UK-based public health physician and epidemiologist, has scanned through approximately 477 COVID-19 trials registered on India’s Clinical Trials Registry. Around 192 of these were observational studies, not multi-phase randomised clinical trials. And at least 53 were for traditional Indian remedies and homoeopathy.

“Many are badly designed and unlikely to set the world alight. Some are downright mischievous,” said Rao. He also advised special caution with the vaccine trials India is conducting: “With drug trials, a repurposed drug is being given to someone already ill. In vaccine trials, an entirely new formulation will be given to un-infected volunteers. Trials have to be done very safely robustly.”

Clinical trials in India for drugs to treat COVID-19 lack the rigour needed to make them trustworthy, medical researchers told IndiaSpend. Ideally these trials should be randomised and controlled, as per the World Health Organization. But current Indian trials have a small number of participants and are characterised by poor and biased study design, experts said*.* These trials also do not follow the globally accepted good practice of being published in peer-reviewed research journals, for the scrutiny of the scientific fraternity.

To date, no drug or vaccine has been found to be effective in curing or preventing the SARS-CoV-2 virus that has affected over 2.8 million Indians and caused more than 53,000 deaths in India till August 20. Indian pharma companies have been racing to repurpose old drugs or offer alternative therapies to treat the disease, while regulators have been hurrying to approve them by waiving accepted research norms. This haste is producing questionable results, experts like Rao fear.

“Whether it’s an electric toaster or a paracetamol tablet, we depend on the reliability and integrity of public regulators to protect us from poor practice. Patients with serious illnesses have little choice but to rely on professionals and regulators to maintain the highest standards in clinical research, so that the drugs they take are both safe and effective,” said Rao.

With clinical trials bypassing accepted norms of research, do doctors and patients have enough data to take the right decision on drugs investigated in Indian clinical trials?

“At our hospital, we strongly believe in evidence-based medicine. So we are not prescribing drugs for COVID-19 which everyone is buzzing about -- like tocilizumab, hydroxychloroquine or favipiravir. I would not take these drugs myself. We need to see robust evidence,” said S.P. Kalantri, director and professor of medicine at the Mahatma Gandhi Institute of Medical Sciences, Maharashtra.

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sansa-bot•

A UK-based epidemiologist scanned almost 500 COVID-19 clinical trials registered in India and found that a large number of them are just observational studies and not randomised multi-phase trials. Besides, he said many of them were "badly designed". Current Indian trials have very small sample sizes and a biased study design, according to medical experts. For some trials, the sample size was as small as 30 participants. UK's RECOVERY trial has had 12,240 participants.

Summary generated by sansa

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