<div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="1942440005" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{12}">Representation of minority groups and women must be improved in cardiovascular clinical device trials, and targeted research site selection can help improve minority enrollment, experts show in a new study.</p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="1341183280" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{14}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">The researchers<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">highlight</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>disparities between the intended-use population (IUP) and coronary stent premarket approval (PMA) studies,</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>but they note that site selection alone cannot improve female enrollment numbers and alternative enrollment strategies should be<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">investigat</span><span class="NormalTextRun SCXW80004424 BCX0">ed.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="2019382953" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{16}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Wayne B. Batchelor, MD, MHS, MBA, of the Inova Health System, Inova Heart and Vascular, Falls Church, Virginia, and colleagues</span><span class="NormalTextRun SCXW80004424 BCX0">, reported the corresponding data in a manuscript published online Tuesday in the<span> </span></span></span><span class="NormalTextRun SCXW80004424 BCX0">Journal of the American College of Cardiology</span><span class="NormalTextRun SCXW80004424 BCX0">.</span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="2111642972" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{18}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Cardiovascular PMA studies<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">often are</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>not completely representative of the IUP. Research site selection may improve this representation, but data<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW80004424 BCX0">are</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>lacking.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="1806096101" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{20}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Investigators in this study examined the impact of site characteristics on the enrollment of minorities and women in coronary stent PMA trials. They also<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">determined</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>whether site<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">selection</span><span> </span><span class="NormalTextRun SCXW80004424 BCX0">alone<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">could<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">change the representation numbers.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="2024796897" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{22}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Using data from nine pivotal coronary stent PMA studies</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>in the U.S. Food and Drug Administration (FDA) database</span><span class="NormalTextRun SCXW80004424 BCX0">, a total of 8,859 patients across 196 sites in the U.S. were evaluated. Region in the U.S.,</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>county demographics, teaching status, Veterans Administration<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">(VA)<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">status, trial volume, female principal investigator (PI)<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">part</span><span class="NormalTextRun SCXW80004424 BCX0">icipation</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>and</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>the number of acute hospital beds were evaluated at each site.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="593394477" paraeid="{4ca9c1c5-1b3e-4e01-adca-9b3b5c405d51}{70}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">The definition of “minority” for this study was non-White race, Hispanic<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">ethnicity</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>or both. Sex was defined as biological sex.<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">Both of these</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>were self-reported by the participants.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1987268726" paraeid="{0c41df50-7d56-49ab-b753-56d2a2e58aa3}{140}"><strong><span class="NormalTextRun SCXW80004424 BCX0">Study results</span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":160,"335559740":279}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" paraid="1610986604" paraeid="{26ebc1cb-3937-423b-837c-9901f9e626ec}{24}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">The investigators found that participants who were in a minority group (12%, participant-to-prevalence ratio [PPR]=0.48) and women (30%, PPR=0.77) were </span><span class="NormalTextRun SCXW80004424 BCX0">underrepresented in coronary stent PMA studies.</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>PPR was the percentage of representation of the group in the study population divided by the percentage of representation of the group in IUP.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="662817281" paraeid="{b267a128-967a-4a5d-8aa1-9f2a4cba32e7}{218}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Enrollment of minority patients changed depending on the region in the U.S. (namely the West and South), county minority population, population<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">density</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>and per-capita income (p<0.001).</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>The investigators proposed that reallocation from low to high minority-enrolling sites can help normalize Black and Hispanic representation (PPR=1.00).</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1901271341" paraeid="{ffc8790d-aa1c-49d5-946a-381ccce805ce}{125}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">In their central illustration, the authors<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">demonstrated</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>the differences between poor and improved representation: Improved representation balances out between 0.8 and 1.2 PPR, considered acceptable representation, when per capita income, Southern Region, Western Region, population<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">density</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>and county minority populations are contributed via site selection. Without these factors, minorities<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">remain</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>underrepresented.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="522781159" paraeid="{5ee9ec9e-253a-4133-a121-ed1302f25f40}{250}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Enrollment of women in clinical trials was more complicated. Research site characteristics were unable to predict female enrollment, and it was less varied between sites based on other differences</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>(non-</span><span class="NormalTextRun SCXW80004424 BCX0">VA, p<0.001). Additionally, few female PIs were involved in the trials (<6%).</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1300191241" paraeid="{2bbd83fe-e289-4885-820d-dfae433901c0}{226}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Several limitations in this study should be considered, including the limited race and ethnicity classification data from the U.S. Census that did not include new race categories and multiracial identification</span><span class="NormalTextRun SCXW80004424 BCX0">;</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>the gender of the PI was considere</span><span class="NormalTextRun SCXW80004424 BCX0">d based on pronouns</span><span class="NormalTextRun SCXW80004424 BCX0">, and this may not accurately represent the sex of research personnel; race and ethnicity of the study PIs were not available; only sites in the U.S. were included; and the analyses focus</span><span class="NormalTextRun SCXW80004424 BCX0">ed on Black and Hispanic groups because representation in other minority groups was limited.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1291737729" paraeid="{efec0430-3f5c-4e9c-902b-ae6353f638d3}{244}"><span class="NormalTextRun SCXW80004424 BCX0">Additionally, this study did not investigate the influence of site selection on device safety and efficacy within each subgroup.</span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2139127611" paraeid="{63531356-6319-4e2a-8e1d-4f8bd15c04fd}{214}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Despite these limitations, these data show how site<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">selection</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>can improve minority representation in coronary device<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">clinica</span><span class="NormalTextRun SCXW80004424 BCX0">l trials.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="677971777" paraeid="{63531356-6319-4e2a-8e1d-4f8bd15c04fd}{21}"><span class="NormalTextRun SCXW80004424 BCX0">“</span><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">These findings have direct implications for the planning and design of future cardiovascular device trials aimed at producing more generalizable safety and efficacy data,” the investigators wrote</span><span class="NormalTextRun SCXW80004424 BCX0">.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="378998331" paraeid="{0c41df50-7d56-49ab-b753-56d2a2e58aa3}{224}"><strong><span class="NormalTextRun SCXW80004424 BCX0">Importance of diversity in clinical trials</span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="655920872" paraeid="{3c5864a0-9ad6-4c81-b62a-296a846d930d}{78}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">In an accompanying editorial, James C. Blankenship, MD, MHCM, and Carolina Ponce-Orellana, MD, both from the University of New Mexico, Albuquerque,<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">discussed the importance of the analyses in this present study.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1352377800" paraeid="{479e72b2-46b5-404f-b61c-c05ef2aa2e95}{212}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">The editorialists wrote that the question of inclusion in clinical trials has been a<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">“thorny” problem for decades in the U.S.</span><span class="NormalTextRun SCXW80004424 BCX0">, and drugs and devices do not equally<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">benefit</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>everyone who receives them.<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">Both the editorial and the study by Batchelor et al gave suggestions to improve both women’s enrollment and minority enrollment in future studies.</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1363006679" paraeid="{7cc84eca-684e-4ddc-ac57-8eeae5d9cff0}{54}"><span class="NormalTextRun SCXW80004424 BCX0">“It is ironic that statistical analysis for the study by Batchelor et al, which was conducted by an experienced U.S. Food and Drug Administration statistician, was cut short by the Federal Executive Orders issued in January 2025 that prohibited activities involving diversity, equity and inclusion and that U.S. Food and Drug Administration personnel who collaborated on this study were not permitted to be co-authors,” the editorialists wrote.</span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1167876905" paraeid="{0c41df50-7d56-49ab-b753-56d2a2e58aa3}{55}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">“Fortunately, the strategies discussed by Batchelor et al and in this editorial are<span> </span></span><span class="NormalTextRun SCXW80004424 BCX0">likely immune</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>to the current political climate. In this current era, research such as this study by Batchelor et al is of heightened importance. The responsibility to include adequate representation of all patient groups in research extends to the entire scientific community.”</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1796790087" paraeid="{58500599-bb27-4f94-812a-4a9189dd73b8}{171}"><strong><span class="NormalTextRun SCXW80004424 BCX0">Sources:</span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="529657374" paraeid="{e5bdb45d-0d34-4ac8-b809-abde6fe27298}{162}"><span class="NormalTextRun SCXW80004424 BCX0">Batchelor WB, Califf R, Mehran R, et al. Aligning coronary stent trial enrollment with the U.S. intended-use population: Implications of site selection.<span> </span></span><em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">J Am Coll </span><span class="NormalTextRun SpellingErrorV2Themed SCXW80004424 BCX0">Cardiol</span></span></em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">. 2026 April 28 (</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW80004424 BCX0">Article in</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>Press).</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1635640059" paraeid="{645839bb-3e15-498b-a52f-eb7e57ca1dec}{117}"><span class="NormalTextRun SCXW80004424 BCX0">Blankenship JC, Ponce-Orellana C. A step toward diversity and inclusion in cardiovascular research trials.<span> </span></span><em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">J Am Coll </span><span class="NormalTextRun SpellingErrorV2Themed SCXW80004424 BCX0">Cardiol</span></span></em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">. 2026 April 28 (</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW80004424 BCX0">Article in</span><span class="NormalTextRun SCXW80004424 BCX0"><span> </span>Press).</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW80004424 BCX0"> <p class="Paragraph SCXW80004424 BCX0" xml:lang="EN-US" lang="EN-US" paraid="502265459" paraeid="{58500599-bb27-4f94-812a-4a9189dd73b8}{216}"><strong><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun MacChromeBold SCXW80004424 BCX0"><span class="NormalTextRun SCXW80004424 BCX0">Image Credit: </span><span class="NormalTextRun SpellingErrorV2Themed SCXW80004424 BCX0">melita</span><span class="NormalTextRun SCXW80004424 BCX0"> – stock.adobe.com</span></span><span class="EOP SCXW80004424 BCX0" data-ccp-props="{}"> </span></strong></p> </div>