Behind the COVID-19 Madness: 1087 clinical trials mostly in vain and wasteful...

CompiledThe medical community is responding to the COVID-19 pandemic at an alarming rate, and there have been many good examples in drug and vaccine developmentHowever, if you look back at the more than 1,000 COVID-19 intervention clinical trials that are currently under way, we'll find that the field is in disarrayPaul Glasziou, director of the Institute of Evidence-Based Medicine at Bond University in Australia, and his colleagues expressed this view in an opinion piece published in the British Medical Journal (BMJ)article points out that a large number of low-quality studies are undermining effective evidence-based responsesAt present, there is a vortex of global research, the results are mixedPositive aspects include increased access to COVID-19 research, increased collaboration, accelerated management and ethical approval of new clinical research, and wider use of preprintsbut many of the problems became apparentIt is estimated that up to 85 per cent of research was wasted prior to the pandemic because of unclear research problems, poor research design, inefficient regulation and enforcement, failure to report results or poorly reported resultsMany of these problems are magnified in COVID-19 studies, and time pressures and inadequate research infrastructure are the causes of these problemssince the beginning of the pandemic, a large number of COVID-19 trials have been registeredAfter analyzing 1087 COVID-19 interventional clinical trials registered in the Clinical Clinical Trials Database (ClinicalTrials.gov), the authors found that while some studies provided useful information, many studies were too small and poorly designed to increase the noise of COVID-19For example, in 145 registered hydroxychloroquine trials, 32 planned samples were 100, 10 were not in control, and 12 were comparative, but not randomThe results of these trials also vary widely, with only 50 multi-centersIt is worth noting that only one provides a clinical protocol, but even limited registration details reveal unreasonable result conversionsin addition, one of the other problems associated with the frenzied influx of COVID-19 clinical trials is that non-drug interventions, such as the use of masks to prevent the spread of the virus, are ignoredThe paper points out that the imbalance in the subject matter of the trial is worrying, especially the lack of non-drug intervention trialsAlthough non-drug interventions are the primary means of mitigating the current outbreak, only two mask trials were found on ClinicalTrials.gov, and no clinical trials were found to test social distance, isolation effects, or compliance, hand hygiene, or other non-drug interventionsCOVID-19 research funding reflects this serious imbalanceA search of Covid-19 ResearchProjectTracker, a real-time database of COVID-19 funding projects, found little research on the thematic effects of non-drug interventions on transmission, compared with at least $74 million to fund hundreds of drug interventionspreprint provides a valuable way to obtain early research resultsArticles on the preprinted Site MedRxiv have increased by more than 400% (from 586 in the last 15 weeks of 2019 to 2,572 in the first 15 weeks of 2020), and the number of views and downloads has increased by 100 timesHowever, many preprinted articles report poor resultsIn systematically reviewing the proportion of asymptomatic COVID-19 studies, the authors found that the sample framework for most studies was unclear, missing cases were not recorded, and "asymptomatic" was not definedThe author also found differences between text and tablesMany of these problems can be corrected (not always before they are published), but poor results reporting complicates the assessment of studies that have already occurred and comprehensive analysiswas discovered by the media because of flawed research, and the acquisition of preprints led to irresponsible disseminationFor example, a pre-print of a hydroxychloroquine study, first reported on March 20th, a non-random study that analyzed 46 patients inappropriately, has been cited 520 timesA larger randomized trial, released on April 14th, showing that hydroxychloroquine had no benefit, received little attentionThe media's unbalanced attention to the first study has triggered a wave of unnecessary or misleading research: 135 hydroxychloroquine studies have been registered on ClinicalTrials.gov since March 20it is important to repeat some of the research, but unnecessary repetition is wastefulA large number of registered hydroxychloroquine evaluation trials are examples, but waste is also available in other types of studiesAt least five studies are conducting a systematic review of community residents' masks at the same time the role of enhanced cooperation and communication using existing research infrastructure is extremely limited, and the pace and volume of COVID-19 studies will make system cracks more visible, with no registry keys in most new research types A centralized, accessible portal , such as hosted by the World Health Organization , can be invaluable when the world is scrambling to study a disease authors cite several important research collaborations related to COVID-19 Most notably, CEPI is developing and testing eight candidate vaccines at the same time, and the alliance already has funding and coordination mechanisms for vaccines Similarly, the UK's multi-centre pilot infrastructure has made it possible to evaluate recovery trials of four COVID-19 drugs, which recruited more than 9,000 patients from 173 centres in less than two months , such examples are rare and there is a lack of coordination in many important areas of epidemiological research Given the risk that vaccines may be ineffective, partially effective, or delayed delivery, there is an urgent need for a CEPI-like agency to coordinate and support neglected non-drug intervention studies such as social isolation, hand hygiene, masks, tracing and environmental modification, which are by far the only effective outbreak control measures waste in research is not new, but the research boom triggered by the outbreak has exacerbated it Although the low quality of COVID-19 research needs immediate attention, other problems must be addressed in the long term and must be addressed before the next pandemic