CYP cynata therapeutics limited

It impressed me that Dimerix another Australia company got 40 or...

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    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 strategies
    Regulatory and ethics considerations
    Delays in approval from regulatory agenciesPrioritise 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 approvalTrial 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 pandemicEducation of ethics committees and introduction of uniform processes
    Infrequently scheduled ethics committee meetingsSchedule 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 responsibilitiesHospitals to recognise research as a public health need and develop internal capacity
    Lack of previous experience with trial conduct and digital platformsRegular 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 restrictionsTrial supervision by the local site-level investigators with remote virtual monitoring
    Source data verification and ensuring data integrityReal-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 unitsExpand the pool of potential research sites with oversight by regional established clinical trial sites
    Misinformation
    Premature recommendations for treatments without scientific dataFrame evidence-based recommendationsResponsible reporting in the media
    The reluctance of clinicians to participate in randomised controlled trialsPrioritise 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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