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content/50.discussion.md

@@ -216,25 +216,28 @@ Figure @fig:ebm-map showcases two choropleths detailing COVID-19 clinical trial
 China, the United States, and France are among the countries with the most clinical trial recruiting for trials with single-country enrollment.
 Many countries have little to no clinical trial recruiting, with the continents of Africa and South America much less represented than Asia, Europe, and North America.
 Trials that recruit across multiple countries do appear to broaden geographic representation, but these trials seem to be heavily dominated by the United States and European Union.
-Dual concerns arise from this skewed geographic representation in clinical trial recruitment: first, it suggests that treatments such as remdesivir that are promising but primarily available to clinical trial participants are unlikely to be accessible by people in many countries, and second, it raises the concern that the findings of clinical trials will be based on participants from many of the wealthiest countries, which may lead to ambiguity in whether the findings can be extrapolated to COVID-19 patients elsewhere.
+**Geographic distribution of COVID-19 clinical trials.**
+The density of clinical trials is reported at the country level.
+As of {{ebm_date_pretty}}, there are {{ebm_trials}} trials in the University of Oxford Evidence-Based Medicine Data Lab's COVID-19 TrialsTracker [@doi:10.5281/zenodo.3732709].
+The top figure demonstrates the density of trials recruiting only from a singular country, while the bottom shows the distribution of recruitment for trials that involve more than one country.
+]({{ebm_map_figure}} "COVID-19 clinical trials"){#fig:ebm-map secno=1}
+
+A few different concerns arise from this skewed geographic representation in clinical trial recruitment.
+First, treatments such as remdesivir that are promising but primarily available to clinical trial participants are unlikely to be accessible by people in many countries.
+Second, it raises the concern that the findings of clinical trials will be based on participants from many of the wealthiest countries, which may lead to ambiguity in whether the findings can be extrapolated to COVID-19 patients elsewhere.
 Especially with the global nature of COVID-19, equitable access to therapeutics and vaccines has been a concern at the forefront of many discussions about policy (e.g., [@doi:10/ggq7mf], yet data like that shown in Figure @fig:ebm-map demonstrates that accessibility is likely to be a significant issue.
 Another concern with the heterogeneous international distribution of clinical trials is that the governments of countries leading these clinical trials might prioritize their own populations once vaccines are developed, causing unequal health outcomes [@doi:10.1001/jama.2020.6641].
 Additionally, even within a single state in the United States (Maryland), geography was found to influence the likelihood of being recruited into or enrolled in a clinical trial, with patients in under-served rural areas less likely to enroll [@doi:10.1016/j.cdp.2005.12.001].
 Thus, geography both on the global and local levels may influence when treatments and vaccines are available and who is able to access them.
 Efforts such as the African Union's efforts to coordinate and promote vaccine development [@doi:10/fgzk] are therefore critical to promoting equity in the COVID-19 response.
 
- ![
-**Geographic distribution of COVID-19 clinical trials.**
-The density of clinical trials is reported at the country level.
-As of {{ebm_date_pretty}}, there are {{ebm_trials}} trials in the University of Oxford Evidence-Based Medicine Data Lab's COVID-19 TrialsTracker [@doi:10.5281/zenodo.3732709].
-The top figure demonstrates the density of trials recruiting only from a singular country, while the bottom shows the distribution of recruitment for trials that involve more than one country.
-]({{ebm_map_figure}} "COVID-19 clinical trials"){#fig:ebm-map secno=1}
 
 Even when patients are located within the geographic recruitment area of clinical trials, however, there can still be demographic inequalities in enrollment.
 When efforts are made to ensure equal opportunity to participate in clinical trials, there is no significant difference in participation among racial/ethnic groups [@doi:10.1002/cncr.28483].
 However, within the United States, real clinical trial recruitment numbers have indicated for many years that racial minorities, especially African-Americans, tend to be under-represented (e.g., [@doi:10.1001/jama.291.22.2720; @doi:10.1245/s10434-007-9500-y; @doi:10.1089/jwh.2010.2469; @doi:10.1007/s11926-018-0728-2]).
 This trend is especially concerning given the disproportionate impact of COVID-19 on African-Americans.
 Early evidence suggests that the proportion of Black, Latinx, and Native American participants in clinical trials for drugs such as remdesivir is much lower than the representation of these groups among COVID-19 patients [@doi:10.1056/NEJMp2021971].
+
 One proposed explanation for differences among racial and ethnic groups in clinical trial enrollment refers to different experiences in healthcare settings.
 While some plausible reasons for the disparity in communication between physicians and patients could be a lack of awareness and education, mistrust in healthcare professionals, and a lack of health insurance [@doi:10.1002/cncr.28483], a major concern is that patients from certain racial and ethnic groups are marginalized even while seeking healthcare.
 In the United States, many patients experience "othering" from physicians and other medical professionals due to their race or other external characteristics such as gender (e.g., [@doi:10.1207/S15327027HC1602_7]).
@@ -247,7 +250,8 @@ Some studies suggest communication between physicians and patients impacts wheth
 For example, researchers utilized a linguistic analysis to assess mean word count of phrases related to clinical trial enrollment, such as voluntary participation, clinical trial, etc. [@doi:10.1002/cncr.28483].
 The data indicated that the mean word count of the entire visit was 1.5 times more for white patients in comparison to Black patients.
 In addition, the greatest disparity between white and Black patients' experience was the discussion of risks, with over 2 times as many risk-related words spoken with white patients than Black patients [@doi:10.1002/cncr.28483].
-Thus, it is likely that COVID-19 clinical trial information is not being equally discussed with Black patients. 
+The trends observed for other clinical trials raise the concern that COVID-19 clinical trial information may not be discussed as thoroughly or as often with Black patients compared to white patients. 
+
  These discrepancies are especially concerning given that many COVID-19 treatments are being or are considered being made available to patients prior to FDA approval through Emergency Use Authorizations.
 In the past, African-Americans have been over-represented relative to national demographics in use of the FDA's Exception From Informed Consent (EFIC) pathway [@doi:10.1377/hlthaff.2018.0501].
 Through this pathway, people who are incapacitated can receive an experimental treatment even if they are not able to consent and there is not sufficient time to seek approval from an authorized representative.