AUTHOR=Tini Giulia , Duso Bruno Achutti , Bellerba Federica , Corso Federica , Gandini Sara , Minucci Saverio , Pelicci Pier Giuseppe , Mazzarella Luca 

TITLE=Semantic and Geographical Analysis of COVID-19 Trials Reveals a Fragmented Clinical Research Landscape Likely to Impair Informativeness

JOURNAL=Frontiers in Medicine

VOLUME=7

YEAR=2020

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.00367

DOI=10.3389/fmed.2020.00367

ISSN=2296-858X

ABSTRACT=<p><bold>Background:</bold> The unprecedented impact of the COVID-19 pandemic on modern society has ignited a “gold rush” for effective treatment and diagnostic strategies, with a significant diversion of economic, scientific, and human resources toward dedicated clinical research. We aimed to describe trends in this rapidly changing landscape to inform adequate resource allocation.</p><p><bold>Methods:</bold> We developed an online repository (COVID Trial Monitor) to analyze in real time the growth rate, geographical distribution, and characteristics of COVID-19 related trials. We defined structured semantic ontologies with controlled vocabularies to categorize trial interventions, study endpoints, and study designs. Analyses are publicly available at <ext-link ext-link-type="uri" xlink:href="https://bioinfo.ieo.it/shiny/app/CovidCT" xmlns:xlink="http://www.w3.org/1999/xlink">https://bioinfo.ieo.it/shiny/app/CovidCT</ext-link>.</p><p><bold>Results:</bold> We observe a clear prevalence of monocentric trials with highly heterogeneous endpoints and a significant disconnect between geographic distribution and disease prevalence, implying that most countries would need to recruit unrealistic percentages of their total prevalent cases to fulfill enrolment.</p><p><bold>Conclusions:</bold> This geographically and methodologically incoherent growth casts doubts on the actual feasibility of locally reaching target sample sizes and the probability of most of these trials providing reliable and transferable results. We call for the harmonization of clinical trial design criteria for COVID-19 and the increased use of larger master protocols incorporating elements of adaptive designs. COVID Trial Monitor identifies critical issues in current COVID-19-related clinical research and represents a useful resource with which researchers and policymakers can improve the quality and efficiency of related trials.</p>