{"id":268902,"date":"2020-09-16T06:20:09","date_gmt":"2020-09-16T10:20:09","guid":{"rendered":"https:\/\/canadianinquirer.net\/v1\/?p=268902"},"modified":"2020-09-16T06:20:09","modified_gmt":"2020-09-16T10:20:09","slug":"covid-vaccine-trials-move-at-warp-speed-but-recruiting-black-volunteers-takes-time","status":"publish","type":"post","link":"https:\/\/canadianinquirer.net\/v1\/2020\/09\/16\/covid-vaccine-trials-move-at-warp-speed-but-recruiting-black-volunteers-takes-time\/","title":{"rendered":"COVID Vaccine Trials Move at Warp Speed, But Recruiting Black Volunteers Takes Time"},"content":{"rendered":"<figure id=\"attachment_260315\" aria-describedby=\"caption-attachment-260315\" style=\"width: 1024px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/07\/man-looking-outside-window-carrying-black-and-brown-backpack-1251861.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-large wp-image-260315\" src=\"https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/07\/man-looking-outside-window-carrying-black-and-brown-backpack-1251861-1024x682.jpg\" alt=\"\" width=\"1024\" height=\"682\" srcset=\"https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/07\/man-looking-outside-window-carrying-black-and-brown-backpack-1251861-1024x682.jpg 1024w, https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/07\/man-looking-outside-window-carrying-black-and-brown-backpack-1251861-300x200.jpg 300w, https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/07\/man-looking-outside-window-carrying-black-and-brown-backpack-1251861-768x512.jpg 768w, https:\/\/canadianinquirer.net\/v1\/wp-content\/uploads\/2020\/07\/man-looking-outside-window-carrying-black-and-brown-backpack-1251861.jpg 1280w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><figcaption id=\"caption-attachment-260315\" class=\"wp-caption-text\">Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. (Pexels photo)<\/figcaption><\/figure>\n<p>Participation in clinical trials among Black people is low, according to <a href=\"https:\/\/urldefense.com\/v3\/__https:\/www.outsourcing-pharma.com\/Article\/2020\/02\/26\/FDA-release-of-clinical-trials-participation-demographics__;!!Iwwt!A7OomVL2HW9yHHDd7uHILfBOcxZPA1NGIR4UpJNtLr-PN08PMbixTeK_Sjp5$\">Food and Drug Administration statistics<\/a>. Still, including them in coronavirus vaccine trials has been a stated priority for the pharmaceutical companies involved, since African American communities, along with those of Latinos, have suffered disproportionately from the pandemic.<\/p>\n<p>The ongoing trials are moving at a pace that is <a href=\"https:\/\/www.npr.org\/sections\/health-shots\/2020\/08\/27\/906240454\/covid-19-vaccine-may-pit-science-against-politics\">unprecedented<\/a> for medical research, with the Trump administration\u2019s vaccine acceleration effort dubbed \u201c<a href=\"https:\/\/www.hhs.gov\/about\/news\/2020\/06\/16\/fact-sheet-explaining-operation-warp-speed.html\">Operation Warp Speed<\/a>.\u201d Yet recruiting minority participants requires sensitivity to a mistrust borne of past and current medical mistreatment. Trust-building cannot be rushed.<\/p>\n<p>So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials \u2014 and targeted outreach efforts to recruit more minorities have been slow to launch.<\/p>\n<p>Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. At Meharry Medical College in Nashville, Tennessee, researchers have set up in-person meetings with patients they already know. Earlier this month, a half-dozen patients gathered in a cramped conference room on campus. They snacked on turkey sandwiches and potato chips and listened to the pitch from their physician, <a href=\"http:\/\/meharrymedicalgroup.com\/provider\/vladmir-berthaud\/\">Dr. Vladimir Berthaud<\/a>.<\/p>\n<p>\u201cWhat\u2019s the best hope to get rid of this virus?\u201d he asked them.<\/p>\n<p>\u201cVaccination,\u201d they replied.<\/p>\n<p>Then Berthaud followed up: \u201cSo raise your hand if you would like to take the vaccine?\u201d<\/p>\n<p>Some hands shot up, but not all.<\/p>\n<p>\u201cI ain\u2019t going to be the first one, now,\u201d said Lanette Hayes.<\/p>\n<p>Katrina Thompson said she does eventually want to get a shot for protection against the coronavirus. She explained she\u2019s especially worried about all the residents of her apartment building who don\u2019t seem to be doing the basics of covering their coughs.<\/p>\n<p>\u201cThe word \u2018vaccination\u2019 don\u2019t scare me,\u201d she said. \u201cThe word \u2018trial\u2019 do.\u201d<\/p>\n<p>Black Americans have reason to be suspicious \u2014 stemming beyond the well-known <a href=\"https:\/\/www.cdc.gov\/tuskegee\/timeline.htm\">Tuskegee experiments<\/a>, in which Black men with syphilis were deceived and mistreated as part of an experiment that went on for decades. Many Black Americans report ongoing mistreatment by medical providers today.<\/p>\n<p>Berthaud is recruiting patients for a clinical trial site he will oversee in Nashville, and he would like more than 300 people of color to enroll. Berthaud, who is Black and from Haiti, appeals to his patients\u2019 sense of duty.<\/p>\n<p>\u201cIf you don\u2019t have enough people like you in those vaccine trials, you will not know if it works for you,\u201d he told them. \u201cYou will not know.\u201d<\/p>\n<p>For most of the current coronavirus vaccine trials, recruitment mainly takes place online \u2014 which often results in mostly white people enrolling.<\/p>\n<p>That\u2019s why Meharry researchers are wooing Black patients with a personal invitation. But they\u2019re not recruiting for the phase 3 trials underway. Meharry\u2019s first trial, for a vaccine candidate by <a href=\"https:\/\/ir.novavax.com\/news-releases\/news-release-details\/novavax-announces-positive-phase-1-data-its-covid-19-vaccine\">Novavax<\/a>, doesn\u2019t launch until October.<\/p>\n<p>Other pharmaceutical companies are <a href=\"https:\/\/www.nih.gov\/news-events\/news-releases\/phase-3-clinical-trial-investigational-vaccine-covid-19-begins\">nearly done<\/a> recruiting. <a href=\"https:\/\/www.modernatx.com\/\">Moderna<\/a> said it chose nearly 100 trial sites for their \u201crepresentative demography.\u201d<\/p>\n<p>The company did not respond to requests for comment but publicizes <a href=\"https:\/\/www.modernatx.com\/cove-study\">demographic statistics<\/a> about the clinical volunteers every week. While somewhat more inclusive than the typical clinical trial, it still is not a good representation of the diversity of the U.S.<\/p>\n<p>For the coronavirus vaccine in particular, the National Institutes of Health has suggested minorities should be overrepresented in testing \u2014 perhaps at rates that are <a href=\"https:\/\/www.cnn.com\/2020\/08\/29\/health\/moderna-coronavirus-vaccine-minorities-goal\/index.html\">double<\/a> their percentage of the U.S. population.<\/p>\n<p>\u201cWe say we want to have everybody included, but really the effort for the vaccinations \u2014 in a sense \u2014 [is] starting the same way they\u2019ve always been,\u201d said Dr. Dominic Mack, of Morehouse School of Medicine in Atlanta.<\/p>\n<p>He\u2019s <a href=\"https:\/\/www.msm.edu\/RSSFeedArticles\/2020\/June\/msm-partners-with-us-department-hhs-40-million-grant.php\">working with the NIH<\/a> to make sure people of color are included in COVID-19 research. Mack said there are no shortcuts if medical research is going to reflect the diversity of the U.S. It takes time to build trust and meaningful relationships with people who have endured a history of abuse or neglect by medical providers, and exclusion from biomedical research and decision-making.<\/p>\n<p>\u201cNow, that being said, the only thing we can do is what we\u2019re doing,\u201d he said \u2014 by which he means respectful, unrushed outreach and dialogue.<\/p>\n<p>The primary effort, called the<a href=\"https:\/\/www.coronaviruspreventionnetwork.org\/\"> COVID-19 Prevention Network<\/a>, taps into four existing clinical trial networks designed to advance HIV research. Those networks are based in Seattle, Atlanta, Los Angeles and Durham, North Carolina.<\/p>\n<p>One project will be led by the <a href=\"https:\/\/www.nmac.org\/team\/rev-ed-sanders\/\">Rev. Edwin Sanders II<\/a> of the Metropolitan Interdenominational Church in Nashville. It will involve seven \u201cfaith ambassadors\u201d and 30 \u201cclergy consultants\u201d in the African American community working to dispel myths and increase trust in the clinical trial process. But Sanders cautioned this is not about a hard sell. It\u2019s not his job to preach trial participation from the pulpit, he said.<\/p>\n<p>\u201cWe are not out beating the drum,\u201d he said, acknowledging that congregants may have legitimate concerns. \u201cI am not going to do anything more than make sure people are able to make an informed choice.\u201d<\/p>\n<p>The danger in lunging for big diversity goals is that it could spark a backlash, meaning minorities might be even less willing to participate, said associate professor <a href=\"https:\/\/www.rachelhardeman.com\/\">Rachel Hardeman,<\/a> who studies health equity at the University of Minnesota. It\u2019s important that the doctors doing the asking look like the people they\u2019re appealing to, she said.<\/p>\n<p>\u201cIt\u2019s racial concordance,\u201d she explained. \u201cIt offers this feeling of, \u2018You know who I am, you know where I come from, you have my best interests at heart.&#8217;\u201d<\/p>\n<p>Historically Black medical institutions in the U.S. are uniquely positioned to do this work. While they haven\u2019t been on the leading edge of recruitment for vaccine trials, they intend to play an important part. The president of Nashville\u2019s Meharry Medical College, <a href=\"https:\/\/www.mmc.edu\/about\/administration\/james_hildreth_bio.html\">Dr. James Hildreth<\/a>, is an infectious disease researcher. But instead of overseeing the trial site being hosted on his campus, Hildreth has a more modest goal in mind: He plans to participate as a patient, and urge others to join him.<\/p>\n<p>\u201cI think my role is more important in advocating for people to be involved in vaccine studies than to be one of the leaders of the study,\u201d he said.<\/p>\n<p>So at Meharry, Berthaud is the principal investigator. As lunch wraps up in the crowded conference room, he has managed to win over some holdouts.<\/p>\n<p>\u201cWhere is the line?\u201d asked Robert Smith. \u201cWhere do we sign?\u201d<\/p>\n<p>Smith, with his young grandson in tow, didn\u2019t raise his hand at first when asked if he\u2019d take the vaccine. But after listening to Berthaud, Smith agreed to participate in the clinical trial \u2014 for no other reason than the trust he has in Berthaud, his longtime physician.<\/p>\n<p>\u201cHe\u2019s not only my doctor; he\u2019s proven that he cares about me,\u201d Smith said.<\/p>\n<p>Persuading hundreds or thousands of Black Americans to sign up will be difficult. But researchers hope their outreach efforts will at least result in more minorities agreeing to take an approved vaccine when available.<\/p>\n<p><em>This story is part of a partnership that includes <a href=\"https:\/\/wpln.org\/\">Nashville Public Radio<\/a>, <a href=\"https:\/\/www.npr.org\/sections\/health-shots\/\">NPR<\/a> and <a href=\"http:\/\/khn.org\">KHN<\/a>.<\/em><\/p>\n<p><em><a href=\"http:\/\/www.kaiserhealthnews.org\/\">Kaiser Health News<\/a> (KHN) is a national health policy news service. It is an editorially independent program of the <a href=\"http:\/\/www.kff.org\/\">Henry J. Kaiser Family Foundation<\/a> which is not affiliated with Kaiser Permanente.<\/em><\/p>\n<h3>USE OUR CONTENT<\/h3>\n<p>This story can be republished for free (<a href=\"https:\/\/khn.org\/news\/lack-of-antigen-test-reporting-leaves-country-blind-to-the-pandemic\/view\/republish\/\">details<\/a>).<\/p>\n<p><a href=\"https:\/\/khn.org\/morning-briefing\/\">Subscribe<\/a> to KHN&#8217;s free Morning Briefing.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/ssl.google-analytics.com\/collect?v=1&amp;t=event&amp;ec=Republish&amp;tid=UA-53070700-2&amp;z=1600251403673&amp;cid=caa9c148-17d2-4ac4-be14-d6f3353ed2f7&amp;ea=https%3A%2F%2Fkhn.org%2Fnews%2Fcovid-vaccine-trials-move-at-warp-speed-but-recruiting-black-volunteers-takes-time%2F&amp;el=COVID%20Vaccine%20Trials%20Move%20at%20Warp%20Speed%2C%20But%20Recruiting%20Black%20Volunteers%20Takes%20Time\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Participation in clinical trials among Black people is low, according to Food and Drug Administration statistics. Still, including them in &hellip;<\/p>\n","protected":false},"author":44,"featured_media":260315,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16,17],"tags":[],"class_list":["post-268902","post","type-post","status-publish","format-standard","has-post-thumbnail","category-news","category-news-w","mauthors-blake-farmer","mauthors-nashville-public-radio","mauthors-kaiser-health-news"],"_links":{"self":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/268902","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/comments?post=268902"}],"version-history":[{"count":1,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/268902\/revisions"}],"predecessor-version":[{"id":268903,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/268902\/revisions\/268903"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media\/260315"}],"wp:attachment":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media?parent=268902"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/categories?post=268902"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/tags?post=268902"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}