Analysis of the WHO ICTRP for novel coronavirus clinical trial registrations

Abstract

Up-to-date information on the current progress made in the research and development to control the global COVID-19 pandemic is important. The study aimed to analyze the clinical trial characteristics and vaccine development progress of the new Coronavirus Disease 2019 (COVID-19) registered with the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP). A comprehensive search of COVID-19 clinical trials since the establishment of the ICTRP to June 11, 2020, was conducted to record and analyze relevant characteristics. Chi-Squared test was used to compare the statistical differences between different research types, interventions, and sources. A total of 3282 COVID-19 clinical trials in 17 clinical trial registration centers were registered with the WHO ICTRP. The main research sources for the present study were ClinicalTrials.gov and ChiCTR. There were significant differences in the parameters of study location ( P = .000), number of participants ( P = .000), study duration ( P = .001), research stage ( P = .000), randomization procedure ( P = .000), and blinding method ( P = .000) between the 2 registration sources. There were significant differences in all the parameters between different kinds of intervention methods. Hydroxychloroquine, plasma therapy, and Xiyanping injection were the high-frequency research drugs used. Ten different vaccine studies were registered under phases I-II. Amongst the studies researched, heterogeneity existed for various parameters. Differences in the type of study, interventions, and registration sources of the studies led to significant differences in certain parameters of the COVID-19 clinical trials. The statistics of high-frequency drugs and the progress of vaccine trials may provide an informative reference for the prevention and control of COVID-19.

Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently?

“…RCTs were mostly small and often investigated the same interventions ( 1 ). Similar observations were made in other reviews of early registered COVID-19 RCTs ( 5 , 6 , 7 , 8 , 9 , 10 ). While these clinical research efforts were much needed, the excessive duplication of efforts and lack of collaboration in the early COVID-19 clinical research agenda was putting it at risk of creating research waste ( 11 ) characterized by unnecessary duplication of trials, poor study designs, and insufficient reporting of results.…”

“…Trials assessing drugs for treating COVID-19 have clearly dominated the clinical research agenda since the beginning of the pandemic ( 1 , 5 , 6 , 7 , 9 , 10 ). Conversely, very little to no data exist regarding non-pharmaceutical measures to help prevent COVID-19, such as for example the use of masks ( 33 ) or school closures ( 34 ).…”

“…COVID-19 is also characterized by an unprecedented volume of research being quickly disseminated in the scientific literature and preprint servers with over 200,000 items published by early December 2020 ( 62 ). For example, the JAMA Network recorded 53% more submissions in the first quarter of 2020 compared with the year before ( 63 ) and MedRxiv saw its median number of daily submission increasing by over 8-fold from before the pandemic (median 6, IQR 4 , 5 , 6 , 7 , 8 ) compared with during the pandemic (median 51, IQR [23; 83]) reaching a total of 7,695 posted articles between July 2019 and June 2020 ( 64 ). The publication process was drastically shorter for COVID-related papers ranging from 6 to 20 days from submission to publication versus over 100 days for non-COVID-19 related papers .…”

Does acute and persistent metabolic dysregulation in COVID-19 point to novel biomarkers and future therapeutic strategies?

“…Scientists, physicians and government institutions from around the globe took an “all-hands on deck” approach with the hope of identifying potential therapies to treat as well as understand the pathophysiology of the disease [ 1 ]. Currently, more than 4800 clinical trials listed on clinicaltrails.gov have been performed or proposed around the world, many with subjects from vastly different ethnic and racial backgrounds, as well as different standard-of-care strategies [ 2 ]. Despite this effort, apart from monoclonal antibodies, few therapies have emerged as effective treatments of COVID-19; vaccines remain the best approach to control and mitigate the pandemic [ 3 ].…”

Estimating the effect of COVID-19 on trial design characteristics: a registered report

“…Our findings contrast with other reports of COVID-19 research quality. Numerous papers have characterized the COVID-19 clinical trial landscape based on trial registrations [32,49–56], generally concluding that COVID-19 studies are of poor quality and that there is substantial room for improvement. However, there was extensive evidence of poor-quality medical research before the pandemic (e.g.…”