{"id":1777,"date":"2016-02-12T14:36:14","date_gmt":"2016-02-12T19:36:14","guid":{"rendered":"http:\/\/www.imperialcrs.com\/blog\/?p=1777"},"modified":"2025-07-07T18:16:25","modified_gmt":"2025-07-07T18:16:25","slug":"wearables-in-cllinical-trials","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/business-insights\/wearables-in-cllinical-trials\/","title":{"rendered":"Wearables in Clinical Trials"},"content":{"rendered":"<h1><span style=\"text-decoration: underline;\">To Wear or Not to Wear is the Question<\/span><\/h1>\n<p>Wearable devices have taken our society,\u00a0and the clinical research industry along with it, by storm. The immediate access to data makes researchers drool.\u00a0 While technology is moving at lightning speed, we must be careful not to get too wrapped up in the hype until we fully understand how we can incorporate this game changer in clinical trials.<\/p>\n<p>Companies like Google, Apple, IBM Watson Health are all partnering with major pharmaceutical companies to evaluate how to engage their products in data collection of an individual&#8217;s health status, not just in the commercial realm, but in R&amp;D as well. Biogen, for example, recently used fitness trackers to gauge study participants&#8217; movements to better gauge their response to the compound.\u00a0 Moreover, with the launch of Apple&#8217;s ResearchKit in 2015, all eyes will stay focused on how health related apps may revolutionize the clinical trial paradigm. Whether we wear it or carry it, technology will change how we receive medical treatment across all platforms.<\/p>\n<p>With all that said, not all is rosy where wearables are concerned. \u00a0There are still several issues to be worked out when it comes to incorporating wearables into clinical trials.<\/p>\n<p>[pullquote]<\/p>\n<h6><strong>The unique identifiers broadcast by all studied devices except for the Apple watch are fixed. These static identifiers enable third parties, such as shopping malls, to persistently monitor where fitness wearables are located at a given point in time.<\/strong><\/h6>\n<p>&nbsp;<\/p>\n<p>[\/pullquote]<\/p>\n<p><span style=\"text-decoration: underline;\"><strong>Engagement<\/strong><\/span><\/p>\n<p>Keeping study volunteers engaged will be a key issue: a <a href=\"https:\/\/endeavourpartners.net\/assets\/Endeavour-Partners-Wearables-and-the-Science-of-Human-Behavior-Change-Part-1-January-20141.pdf\">study<\/a> by Endeavour Partners\u00a0found that more than half of people\u00a0who have owned a wearable\u00a0tracker no longer use it. Furthermore, a third stopped using the device within six months of receiving it. \u00a0Simply providing a device to patients or allowing them to use their own during a trial will not be enough. \u00a0Trial organizers will need to come up with creative ways to keep participants engaged and motivated to continue using the devices.<\/p>\n<p><span style=\"text-decoration: underline;\"><strong>Ethical Issues<\/strong><\/span><\/p>\n<p>Wearables are easily transferred to another. \u00a0Will companies be able to decipher this and how can data remain credible if this happens? \u00a0Indeed, there are trials where participants are being given fitness trackers to see if they are fit for a particular treatment. \u00a0If a person gets a wearable and wants to insure that they are &#8220;active enough&#8221; to receive a perceived benefit or course of treatment, what&#8217;s to keep them from giving it to someone else to ensure they get in?<\/p>\n<p><strong>Data security and informed consent<\/strong>. \u00a0There has been a wealth of information released by makers of fitness trackers lately on everything from <a href=\"https:\/\/gadgetsandwearables.com\/2015\/12\/16\/who-gets-more-sleep-men-or-women-jawbone-crunches-the-data\/\">male vs. female sleep patterns<\/a> to the ability to predict a woman is pregnant. \u00a0 \u00a0Sure, the makers of these trackers are using the data &#8220;anonymously&#8221; but he fact that they are collecting it at all is somewhat troubling and it can&#8217;t be too hard to correlate data to a specific device if they so choose. \u00a0Have these users been given the option to opt out? \u00a0Indeed countries are approaching these questions with differing results. \u00a0An\u00a0<a href=\"https:\/\/www.appliedclinicaltrialsonline.com\/data-privacy-concerns-between-eu-us-intensifies\">article<\/a> from Susan Shelby, PhD which appeared in Applied Clinical Trials recently highlights the data privacy issues between the EU and the US with the revocation of Safe Harbor. \u00a0U.S. companies generally are allowed to commercially share data, provide it to authorities, or even sell it because it is classified as &#8220;fitness&#8221; information as opposed to &#8220;health&#8221; information. Data for clinical trials could be even more troubling. \u00a0Will device manufacturers know what devices are participating in a trial? \u00a0Will they have access to that data in addition to the sponsor? \u00a0With the increasing capabilities of wearables, at what point does fitness data become health data? \u00a0What about participants? \u00a0If they are provided with data showing average results, will they try to improve or &#8220;win&#8221;? and what will this mean for the validity of study data? \u00a0Indeed these are likely some of the questions the FDA had when they requested comments at the end of 2015 on BYOD and technology use in clinical trials. (See\u00a0<a href=\"https:\/\/www.regulations.gov\/#!docketDetail;rpp=100;so=DESC;sb=docId;po=0;D=FDA-2015-N-3579\">Using Technologies and Innovative Methods to Conduct FDA-Regulated Clinical Investigations of Investigational Drugs<\/a>. \u00a0The link will take you to all submitted documents and comments)<\/p>\n<p>A recent <a href=\"https:\/\/openeffect.ca\/reports\/Every_Step_You_Fake.pdf\">study<\/a> by Canadian nonprofit Open Effect studied the security and privacy of many\u00a0popular wearable devices. \u00a0Their findings-&#8220;the unique identifiers broadcast by all studied devices except for the Apple watch are fixed. These static identifiers enable third parties, such as shopping malls, to persistently monitor where fitness wearables are located at a given point in time.&#8221; \u00a0They also found other security vulnerabilities exist and that data could be falsified by someone interested in doing so.<\/p>\n<p><span style=\"text-decoration: underline;\"><strong>The Bottom Line<\/strong><\/span><\/p>\n<p>While the promise of wearables\u00a0 is extremely intriguing and exciting, we must proceed with caution and take steps to not get carried away. \u00a0Steps must be taken to insure privacy and data viability. \u00a0What that exactly means, I don&#8217;t know, it&#8217;s yet to be determined, but we all will have a voice in shaping debate and results. \u00a0I can&#8217;t wait to see how this shakes out.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>To Wear or Not to Wear is the Question Wearable devices have taken our society,\u00a0and the clinical research industry along with it, by storm. The immediate access to data makes researchers drool.\u00a0 While technology is moving at lightning speed, we must be careful not to&hellip;<\/p>\n","protected":false},"author":26,"featured_media":71596,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[22,35],"tags":[342,83,1738,50,1735,1734,1737,1739,1741,1733,1736,1732,312,1740],"class_list":["post-1777","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-insights","category-patient-recruitment-and-retention","tag-byod","tag-clinical-research","tag-clinical-trial-technology-trends","tag-clinical-trials","tag-digital-health-monitoring-in-trials","tag-impact-of-wearables-on-clinical-studies","tag-patient-data-from-wearable-devices","tag-remote-patient-monitoring","tag-technology-adoption-in-clinical-trials","tag-wearable-devices-for-medical-research","tag-wearable-sensors-in-healthcare-research","tag-wearable-technology-in-clinical-trials","tag-wearables","tag-wearables-and-patient-engagement"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Wearables in Clinical Trials<\/title>\n<meta name=\"description\" content=\"Whether we wear it or carry it, technology will change how we receive medical treatment across all platforms. 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