It impressed me that Dimerix another Australia company got 40 or so patients out of trials in India (which was far, far fewer than what they wanted - they wanted either 400 or 600 or some large number like those - so they failed and wasted money too really, in my opinion) but they did get 40 which was more than the 24 the MEND trial protocol (which I think was pretty much fatally flawed on the drawing board for confounding - but nonetheless it only required 24) managed to get in a similar time frame.
I would wait with being impressed until the data is released. Data integrity is a vital part here and has been an issue in the past:
[4/20/2016] FDA is notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Semler Research Private Limited (Semler) located in Bangalore, India, are not acceptable as a result of data integrity concerns, and need to be repeated. Semler is a contract research organization that conducts bioequivalence and bioavailability studies for a number of pharmaceutical companies.
[9/28/2021] FDA asks pharmas to repeat studies done at 2 Indian CROs due to data integrity issues
That was pre-COVID. I believe we have all seen the pictures of what happened in India during COVID.
An article in The Lancet may be worth a read:
Challenges in operationalising clinical trials in India during the COVID-19 pandemic
Challenges and potential supportive strategies for the initiation and conduct of clinical trials in India during the COVID-19 pandemic
Recommended strategiesRegulatory and ethics considerations Delays in approval from regulatory agencies Prioritise investigator-initiated trials of public health importanceExpedite review of academic trials that address questions of public health importanceStreamline regulatory approval processes with prescribed timelines for review of proposalsEliminate redundancy in approval processes Delays between ethics submission and approval Trial sites and ethics committees to comply with the Indian Council of Medical Research guidelines to facilitate urgent public health trials, including accepting approvals from a central ethics committee The unfamiliarity of ethics committee members with the Indian Council of Medical Research guidelines for the conduct of clinical trials during a pandemic Education of ethics committees and introduction of uniform processes Infrequently scheduled ethics committee meetings Schedule ethics committee meetings virtuallyEthics committee secretariat to prioritise urgent public health trials for expedited review or emergency meeting of full committee Site-level considerations Issues with site set-ups and delegation of site-level responsibilities Hospitals to recognise research as a public health need and develop internal capacity Lack of previous experience with trial conduct and digital platforms Regular good clinical practice training and simulation activities for the core trial staffIncorporation of research into medical and nursing curriculaTraining on use of electronic case report forms Limited scope for site visits by trial management team due to travel restrictions Trial supervision by the local site-level investigators with remote virtual monitoring Source data verification and ensuring data integrity Real-time data entry into electronic case report forms with validation rulesUse of virtual tools for source document verification Lack of participation by remote and smaller health units Expand the pool of potential research sites with oversight by regional established clinical trial sites Misinformation Premature recommendations for treatments without scientific data Frame evidence-based recommendationsResponsible reporting in the media The reluctance of clinicians to participate in randomised controlled trials Prioritise urgent public health research by apex medical bodies, such as the Medical Council of IndiaAdvocate for the importance of high-quality trials as the mechanism to establish the safety and efficacy of interventionsInformation generation and myth-buster programmes
How good are an additional ~12 patients in a 24 patient clinical trial when you run at (an expensive!) risk of having your whole trial data questioned?
Wait for a data breakdown of the trials run by the two Australian company that recruited patients in India over there, then I'm happy to discuss the (in my opinion) simplistic "we-should-have" and "why-didn't-we" points in the failed MEND trial argument.
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