Results from expanded access programs: a review of academic literature 131 7♦ 50 100 150 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 COVID-19 Non-COVID-19 Year of publication Number of publications Figure 8: Bar chart of the absolute number of peer-reviewed expanded access publications of therapeutic investigations over time. The descriptive statistics are provided in Table 3. The median number of patients described was 43, but this number varied widely, ranging from N=1 in case reports to N= 95,000. Case reports comprised almost one in eight (12.3%) publications. Of the non-case-report publications (i.e., N>1), the median number of patients was 57, with an interquartile range (IQR) of 18 to 198 patients. Most of the data had been collected retrospectively (51%), and only 12.1% (149/1,231) of all publications were international collaborations. For national (single-country) publications (n=1,082), the majority (51.1%) were collaborative publications between multiple hospitals. Most studies only included adults; 22% included mixed populations with both adults and children, or children only. Researchers in the US generated the most publications in absolute terms (22.1%, 240/1,082), followed by Italy (16.9%, 183/1,082) and France (8.3%, 90/1,082), see Table 4. When we calculated the number of publications relative to the average populations (in millions) from these countries during the midpoint of the time period (2006-2016), Italy had the highest output per capita with 3.1 articles per million inhabitants. Italy is followed by Belgium and Spain with a relative publication output of 2.5 and 1.8 per million inhabitants, respectively. Table 4 shows the geographic distribution of the top ten most productive regions in terms of expanded access publications. Europe and the Americas accounted for 87.4% of all publications, whereas Africa only accounted for 0.6%. Highincome regions (North/South/West Europe and Northern America) comprised 82.5% percent of all publications and 92.4% of all patients described in our data set (Figure 9).
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