{"id":10013,"date":"2023-08-04T09:24:34","date_gmt":"2023-08-04T13:24:34","guid":{"rendered":"https:\/\/clariowebstg.wpengine.com\/?post_type=articles&#038;p=10013"},"modified":"2024-09-20T05:25:41","modified_gmt":"2024-09-20T09:25:41","slug":"the-role-of-patient-choice-and-control","status":"publish","type":"articles","link":"https:\/\/clario.com\/resources\/articles\/the-role-of-patient-choice-and-control\/","title":{"rendered":"The Role of Patient Choice and Control"},"content":{"rendered":"\n<h2 class=\"wp-block-heading h3\" id=\"h-how-byod-creates-patient-centric-success-in-clinical-trials\">How BYOD creates patient-centric success in clinical trials<\/h2>\n\n\n\n<p><strong>Kelly Dumais, Ph.D. <\/strong>&#8211; Director, eCOA Science and Consulting at Clario<\/p>\n\n\n\n<p>The use of Bring-your-own-device (BYOD) in clinical trials has evolved with the growth of smart phones. Research shows that trial participants would be willing to use their own device for a clinical trial<sup>1<\/sup>, including those over the age of 60<sup>2<\/sup>. Medicine agencies have acknowledged the use of BYOD in their most recent guidance. The EMA states that \u201cBoth ePRO data and clinician reported outcome data may be captured by privately owned devices such as mobile phones, tablets, computers and wearables, i.e., BYOD.\u201d<sup>4<\/sup>.&nbsp;<\/p>\n\n\n\n<p>The potential impact of BYOD on compliance has been a concern, however Clario research<sup>3<\/sup> indicates that BYOD compliance remains high when using BYOD, while assessment completion time is comparable. Based on that, adding BYOD to a clinical trial may seem like a foregone conclusion, especially if it saves on device training and shipping cost.<\/p>\n\n\n\n<figure class=\"wp-block-pullquote py-0\"><blockquote><p>&#8230;however Clario research indicates that BYOD compliance remains high when using BYOD, while assessment completion time is comparable&#8230;<\/p><\/blockquote><\/figure>\n\n\n\n<p>For BYOD to be used successfully in any study however, it should be approached from the patient\u2019s perspective and be seen as a strategy to improve patient participation and compliance, not as a means to reduce operational overhead. The <a href=\"https:\/\/clario.com\/resources\/articles\/frequently-asked-questions-2023-ema-and-fda-guidance\/\">EMA guidance<\/a> says that \u201cIt is necessary to provide alternative ways of data collection e.g., devices provided by the sponsor, as the trial participants should not be excluded from a trial if not capable of or willing to use BYOD\u201d<sup>4<\/sup>. Consider the patient population, age and location, and the smartphone penetration in the geographies where the trial is looking to recruit.<\/p>\n\n\n\n<p>A further consideration is to look at the meta data to understand the impact of using BYOD within the trial\u2019s therapeutic area (TA) and indication. Compliance can vary<sup>3<\/sup> depending on the TA, indication and the assessment burden placed on the patient.&nbsp;<\/p>\n\n\n\n<p>Although none of these are actual barriers for implementing BYOD, they are considerations which help to inform how BYOD can be part of the PRO strategy and how to optimize the use of BYOD accordingly, through varying the percentage of provisioned devices e.g., based on smartphone use and trial population.&nbsp;<\/p>\n\n\n\n<p>BYOD offers trial participants a choice and, rather than giving them an additional device, BYOD makes use of participants\u2019 familiarity with their own mobile phone. In addition, clinical trials can at times put impossible standards on patients about what to do and when to do it and complete diaries so frequently and for so long. BYOD gives patients an element of control back and a say in the process.&nbsp;<\/p>\n\n\n\n<p>These are important concerns for participants when deciding whether or not to take part in a study, especially if it includes symptom-based diaries where they may be entering data throughout the day. And once the decision has been made to use BYOD, it helps to make the choice device by the patient part of the study recruitment strategy.<\/p>\n\n\n\n<p>In summary, a successful BYOD strategy should be offered as a patient-centric and data-driven choice. Although any given clinical trial is unlikely to be 100% BYOD, as provisioned devices should be made available to accommodate participants that don&#8217;t want to use or have their own phone, a considered BYOD strategy will likely support recruitment efforts and improve participant retention in clinical trials.<\/p>\n\n\n<div class=\"row m4-3 purple\">\n\t\n\n<div class=\"col-12 col-md-11\">\n\t\t\t\n\n<div class=\"wp-block-group p-3 h-100\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"h3\">Pioneering enhanced accessibility in clinical trials<\/p>\n\n\n\n<p>The quest for making clinical trials more accessible is continuous and crucial. Clario delves into the significance of zoom functionality, revealing its transformative potential to broaden accessibility and enhance the trial experience for participants.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-secondary\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/clario.com\/resources\/articles\/improving-accessibility-in-clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">Read article<\/a><\/div>\n<\/div>\n<\/div><\/div>\n\n\t<\/div>\n\n<\/div>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\"><div class=\"row mt-3 mb-2\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h4 class=\"wp-block-heading\" id=\"h-written-by\">Written by<\/h4>\n\n\t<\/div>\n\n<\/div>\n\n\n<div class=\"row\">\n\t\n\n<div class=\"col-6 col-sm-4 col-md-4 col-lg-4 col-xl-4\">\n\t\t\t\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"713\" height=\"716\" src=\"https:\/\/clario.com\/wp-content\/uploads\/2023\/03\/K-Dumais.jpg\" alt=\"\" class=\"wp-image-8668\" srcset=\"https:\/\/clario.com\/wp-content\/uploads\/2023\/03\/K-Dumais.jpg 713w, https:\/\/clario.com\/wp-content\/uploads\/2023\/03\/K-Dumais-597x600.jpg 597w, https:\/\/clario.com\/wp-content\/uploads\/2023\/03\/K-Dumais-300x300.jpg 300w, https:\/\/clario.com\/wp-content\/uploads\/2023\/03\/K-Dumais-250x250.jpg 250w\" sizes=\"auto, (max-width: 713px) 100vw, 713px\" \/><\/figure>\n\n\n\n<p class=\"pb-0 mb-0\"><strong>Kelly Dumais, Ph.D.<\/strong><\/p>\n\n\n\n<p class=\"pt-0 mt-0 has-dark-pink-color has-text-color\">Director, eCOA Science and Consulting<\/p>\n\n\t<\/div>\n\n\n\n<div class=\"col-12 col-md-4\">\n\t\t\t<div class=\"h-100 d-flex flex-column justify-content-start\">\n\t\t\t\t\t<\/div>\n\t<\/div>\n\n\n\n<div class=\"col-12 col-md-4\">\n\t\t\t\t<\/div>\n\n<\/div>\n<\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-css-opacity mt-1\"\/>\n\n\n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-12\">\n\t\t\t\n\n<h4 class=\"wp-block-heading\" id=\"h-references\">References<\/h4>\n\n\n\n<p><sup>1 <\/sup>Shahraz et al, 2021, Journal of Patient-Reported Outcomes<\/p>\n\n\n\n<p><sup>2<\/sup> Byrom et al., ISPOR 20<sup>th<\/sup> Annual European Congress, Nov. 2017<\/p>\n\n\n\n<p><sup>3<\/sup> Clario research<\/p>\n\n\n\n<p><sup>4<\/sup> EMA, 2023. Guideline on computerized systems and electronic data in clinical trials. Available at: <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf\">https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf<\/a> <\/p>\n\n\t<\/div>\n\n<\/div>\n","protected":false},"featured_media":2633,"template":"","tags":[131],"solution_areas":[42],"therapeutic_area":[],"article_type":[323],"class_list":["post-10013","articles","type-articles","status-publish","has-post-thumbnail","hentry","tag-ecoa"],"acf":[],"cp_meta_data":{"_edit_lock":["1726824342:14"],"_edit_last":["14"],"page_title":[""],"_page_title":["field_615dbd9cfca50"],"display_prefooter":["hide"],"_display_prefooter":["field_61641783f0f7c"],"external_link":[""],"_external_link":["field_615ef0c11046c"],"asset_link":[""],"_asset_link":["field_61746513234de"],"_yoast_wpseo_metadesc":["The use of Bring-your-own-device (BYOD) in clinical trials has evolved with the growth of smart phones."],"_yoast_wpseo_content_score":["30"],"_yoast_wpseo_focuskeywords":["[{\"keyword\":\"COA\",\"score\":40},{\"keyword\":\"eCOA\",\"score\":40},{\"keyword\":\"BYOD\",\"score\":67},{\"keyword\":\"provisioned devices\",\"score\":40}]"],"_yoast_wpseo_keywordsynonyms":["[\"\",\"\",\"\",\"\",\"\"]"],"_yoast_wpseo_estimated-reading-time-minutes":["4"],"_yoast_wpseo_wordproof_timestamp":[""],"_wp_old_date":["2023-08-03"],"_yoast_indexnow_last_ping":["1726824341"],"_wp_old_slug":["why-successful-byod-is-about-patient-choice-and-control"],"_yoast_post_redirect_info":["a:4:{s:6:\"origin\";s:74:\"resources\/articles\/why-successful-byod-is-about-patient-choice-and-control\";s:6:\"target\";s:57:\"resources\/articles\/the-role-of-patient-choice-and-control\";s:4:\"type\";i:301;s:6:\"format\";s:5:\"plain\";}"],"_thumbnail_id":["2633"],"bt_post_experiments_editor":["gutenberg"]},"_links":{"self":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/articles\/10013","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/articles"}],"about":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/types\/articles"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/media\/2633"}],"wp:attachment":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/media?parent=10013"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/tags?post=10013"},{"taxonomy":"solution_areas","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/solution_areas?post=10013"},{"taxonomy":"therapeutic_area","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/therapeutic_area?post=10013"},{"taxonomy":"article_type","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/article_type?post=10013"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}