{"id":233,"date":"2020-07-19T11:01:35","date_gmt":"2020-07-19T15:01:35","guid":{"rendered":"https:\/\/mrctcenter.org\/diversity-in-clinical-research\/?page_id=233"},"modified":"2020-07-19T11:01:35","modified_gmt":"2020-07-19T15:01:35","slug":"action-for-change","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/diversity-in-clinical-research\/guidance\/action-for-change\/","title":{"rendered":"Action for Change"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_empty_space][vc_column_text]<\/p>\n<h1>Overview<\/h1>\n<p>There are practical and operational barriers that prevent routine participation of underrepresented, underserved, and diverse populations in clinical research. These must be addressed to promote change. While many challenges exist, for each section, we provide a key summary and recommendations to address appropriate representation in clinical research.<\/p>\n<p>These section are interdependent and dynamic. We have much to learn to implement and sustain change.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1616956282190{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;margin-left: 0px !important;padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #e0bf55 !important;border-radius: 5px !important;}&#8221;]Promoting diverse representation and inclusion in clinical research is a <strong>shared responsibility by all stakeholders<\/strong> in the research enterprise.[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1608311066195{background-color: #152736 !important;}&#8221;][vc_column css=&#8221;.vc_custom_1607549519681{margin-top: 0px !important;margin-bottom: 16px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 16px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1607621349821{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}&#8221;]<\/p>\n<h1 style=\"text-align: center\"><span style=\"color: #ffffff\">Broadening Engagement<\/span><\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221;][vc_column][vc_row_inner][vc_column_inner][vc_column_text]Clinical interventions and research aim to improve disease diagnosis, treatment, and\/or prevention to promote health. Active engagement of patients and participants, their families and caregivers, advocacy groups, the community, and health care providers is necessary for successful implementation of clinical research.<\/p>\n<p>A diverse workforce is also necessary to support, promote, and exemplify diversity.[\/vc_column_text][vc_single_image image=&#8221;916&#8243; img_size=&#8221;full&#8221; onclick=&#8221;link_image&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1608311054051{background-color: #152736 !important;}&#8221;][vc_column css=&#8221;.vc_custom_1607549519681{margin-top: 0px !important;margin-bottom: 16px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 16px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1607621490018{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}&#8221;]<\/p>\n<h1 style=\"text-align: center\"><span style=\"color: #ffffff\">Study Design, Conduct, and Implementation<\/span><\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1615919704852{background-color: #ffffff !important;}&#8221;]Issues related to study design, conduct, and implementation should be considered through the lens of including diverse populations. These topics include but are not limited to:[\/vc_column_text][vc_row_inner css=&#8221;.vc_custom_1610397825606{margin-top: 8px !important;margin-right: 15px !important;margin-bottom: 15px !important;margin-left: 15px !important;border-top-width: 3px !important;border-right-width: 3px !important;border-bottom-width: 3px !important;border-left-width: 3px !important;padding-right: 8px !important;padding-bottom: 8px !important;padding-left: 8px !important;border-left-color: #00798f !important;border-left-style: solid !important;border-right-color: #00798f !important;border-right-style: solid !important;border-top-color: #00798f !important;border-top-style: solid !important;border-bottom-color: #00798f !important;border-bottom-style: solid !important;border-radius: 3px !important;}&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1613602401727{background-color: #ffffff !important;}&#8221;]<\/p>\n<ul>\n<li>Product lifecycle<\/li>\n<li>Research question<\/li>\n<li>Study design<\/li>\n<li>Eligibility (inclusion\/exclusion) criteria<\/li>\n<li>Recruitment plans<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Feasibility assessments<\/li>\n<li>Retention issues<\/li>\n<li>Logistics of study conduct<\/li>\n<li>Participant payments<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1608311033844{background-color: #152736 !important;}&#8221;][vc_column css=&#8221;.vc_custom_1607549519681{margin-top: 0px !important;margin-bottom: 16px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 16px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1607621434889{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}&#8221;]<\/p>\n<h1 style=\"text-align: center\"><span style=\"color: #ffffff\">Data Standards and Analysis<\/span><\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]How data are collected, reported, and analyzed are specific to the disease or condition and to the research study. The collection, reporting and analysis of the data, relevant for diverse populations, should be planned.[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/6&#8243;][vc_icon icon_fontawesome=&#8221;fas fa-clipboard&#8221; color=&#8221;custom&#8221; background_style=&#8221;rounded&#8221; background_color=&#8221;custom&#8221; align=&#8221;center&#8221; custom_color=&#8221;#ffffff&#8221; custom_background_color=&#8221;#00798f&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;5\/6&#8243;][vc_column_text]<strong>Data variables, collection, and reporting.<\/strong> Primary data should be collected with the greatest specificity possible so that it can be categorized, shared, and\/or analyzed in different ways for different purposes. Once the specific data are known, then any risks of that collection, specific to the subgroup and population, can be identified, mitigated, and explained to potential participants.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/6&#8243;][vc_icon icon_fontawesome=&#8221;fas fa-chart-line&#8221; color=&#8221;custom&#8221; background_style=&#8221;rounded&#8221; background_color=&#8221;custom&#8221; align=&#8221;center&#8221; custom_color=&#8221;#ffffff&#8221; custom_background_color=&#8221;#00798f&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;5\/6&#8243;][vc_column_text css=&#8221;.vc_custom_1610386797697{padding-top: 14px !important;}&#8221;]<strong>Data analysis<\/strong>. Analysis should include subgroup identification and analysis.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1609164965638{background-color: #152736 !important;}&#8221;][vc_column css=&#8221;.vc_custom_1607549519681{margin-top: 0px !important;margin-bottom: 16px !important;border-top-width: 0px !important;border-bottom-width: 0px !important;padding-top: 16px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1607621579350{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 0px !important;}&#8221;]<\/p>\n<h1 style=\"text-align: center\"><span style=\"color: #ffffff\">Stakeholder Commitments and the Future<\/span><\/h1>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1616553500833{padding-top: 16px !important;}&#8221;]Stakeholders involved in the clinical research enterprise include funders, sponsors, CROs, research institutions and sites, investigators and their study teams, patient and patient advocacy groups, and others. Stakeholders are also institutional review boards\/research ethics committees, human research protection programs, journal editors, and others.<\/p>\n<p>No single entity can achieve or is responsible for diversity alone. Everyone shares responsibility for inclusion of diverse populations in clinical research.<\/p>\n<p>Stakeholders rely on, and must be comfortable with holding, another entity accountable and help one another to achieve success.<\/p>\n<p>Shared accountability may be formalized by contract or informally through conversation and common alignment.<\/p>\n<p>We offer the following set of initial questions for an organization to consider:[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;1227&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;link_image&#8221;][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=&#8221;.vc_custom_1610397064429{margin-right: 20px !important;margin-left: 20px !important;border-top-width: 2px !important;border-right-width: 2px !important;border-bottom-width: 2px !important;border-left-width: 2px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;padding-left: 0px !important;border-left-color: #00798f !important;border-left-style: solid !important;border-right-color: #00798f !important;border-right-style: solid !important;border-top-color: #00798f !important;border-top-style: solid !important;border-bottom-color: #00798f !important;border-bottom-style: solid !important;border-radius: 2px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1609165419823{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #00798f !important;}&#8221;]<\/p>\n<p style=\"text-align: center\"><span style=\"color: #ffffff\">The following questions highlight the internal structure, messaging, and coordination across and throughout the organization to promote diversity in research<\/span><\/p>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1615919641716{padding-top: 15px !important;padding-right: 15px !important;padding-bottom: 15px !important;padding-left: 15px !important;}&#8221;]<\/p>\n<ul>\n<li>Has the organization posted a public statement of commitment to diversity and inclusion in clinical research?<\/li>\n<li>Does the organizational mission or corporate responsibility statement reference diversity and inclusion?<\/li>\n<li>Does the strategic plan include programmatic goals related to diversity and inclusion?<\/li>\n<li>Are those responsible for fulfilling expectations and\/or driving implementation appropriately identified and positioned within the organization?<\/li>\n<li>Are the operational requirements for achieving diversity coordinated across the necessary organizational components?<\/li>\n<li>Does messaging and communication within the organization follow <a href=\"https:\/\/mrctcenter.org\/health-literacy\/\" target=\"_blank\" rel=\"noopener noreferrer\">health literate language principles<\/a> and promote diversity and inclusion?<\/li>\n<li>Are there organization-wide efforts to recruit and train a workforce that can effectively develop and implement a diversity agenda?<\/li>\n<li>Has the organization allocated resources necessary to fulfill these functions?<\/li>\n<li>Does the organization have metrics to measure expectations and plans?<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column][vc_raw_js]JTNDc2NyaXB0JTIwdHlwZSUzRCUyMnRleHQlMkZqYXZhc2NyaXB0JTIyJTNFJTIwalF1ZXJ5JTI4JTIwZnVuY3Rpb24lMjglMjQlMjklMjAlN0IlMEElMEElMjAlMjAlMjQlMjhkb2N1bWVudCUyOS5vbiUyOCUyN3RvdWNoc3RhcnQlMjBjbGljayUyNyUyQyUyMCUyN2xpLnZjX3R0YS10YWIlMjBhJTJDbGkudmNfdHRhLXRhYiUyQy52Y190dGEtcGFuZWwtdGl0bGUlMjclMkMlMjBmdW5jdGlvbiUyOCUyOSU3QiUwQSUyMCUyMCUyMCUyMCUyMCUyNCUyOCUyN2h0bWwlMkMlMjBib2R5JTI3JTI5LnN0b3AlMjglMjklM0IlMEElMjAlMjAlN0QlMjklM0IlMEElMEElMEElN0QlMjklM0IlMjAlM0MlMkZzY3JpcHQlM0U=[\/vc_raw_js][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_empty_space][vc_column_text] Overview There are practical and operational barriers that prevent routine participation of underrepresented, underserved, and diverse populations in clinical research. These must be addressed to promote change. While many challenges exist, for each section, we provide a key summary and recommendations to address appropriate representation in clinical research. These section are interdependent and dynamic. [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":1545,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-233","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.0 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Action for Change - Diversity, Inclusion, and Equity in Clinical Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mrctcenter.org\/diversity-in-clinical-research\/guidance\/action-for-change\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Action for Change\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_empty_space][vc_column_text] Overview There are practical and operational barriers that prevent routine participation of underrepresented, underserved, and diverse populations in clinical research. 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