{"id":12267,"date":"2021-08-18T09:04:55","date_gmt":"2021-08-18T09:04:55","guid":{"rendered":"https:\/\/dataethics.eu\/?p=12267"},"modified":"2021-08-18T09:06:05","modified_gmt":"2021-08-18T09:06:05","slug":"when-clinical-trials-go-digital-ethics-is-needed","status":"publish","type":"post","link":"https:\/\/dataethics.eu\/da\/when-clinical-trials-go-digital-ethics-is-needed\/","title":{"rendered":"When Clinical Trials Go Digital, Ethics Is Needed"},"content":{"rendered":"\n<p><strong>Digitalization is changing the landscape of clinical research. Ushered in by the pandemic, so-called decentralized clinical trials are quickly becoming widespread, utilizing electronic consent forms, instruction videos, mobile phone sensors, algorithms, and dedicated apps for data collection. There are many clear advantages, but also a number of challenges from a privacy and ethics point of view. <\/strong><\/p>\n\n\n\n<p>There are many apparent advantages to this new reality of scientific investigations. The first concerns increased ease of participation in research. Today, many studies fail to recruit and retain the required number of participants in order to meet their enrollment timeline. Only a small selection of the population actually take part in clinical trials. <a href=\"https:\/\/www.centerwatch.com\/articles\/24924-patient-willingness-to-join-clinical-trials-drops-dramatically-new-data-show\">Data from a survey by CISCRP<\/a> indicates that physical distance to research sites is one of the main barriers to increased participation.&nbsp;<\/p>\n\n\n\n<p>The second advantage concerns the amount of data that researchers can generate from a decentralized study. Compare for instance the following two studies on Parkinson\u2019s disease, collecting similar types of data. In the first study, with a traditional design, 600 participants met once a year with the investigators for an interview and were given a phone call and a mail survey to collect additional data once every six months. In contrast, in the second study, with a decentralized study design, 8000 participants were enrolled on the first day of the study, and investigators collected the same kind of data twice a day (instead of twice per year) through sensors on mobile phones.&nbsp;<\/p>\n\n\n\n<p>The third advantage of decentralized clinical trials concerns inclusion and equitable access to research participation. Not everybody have the same opportunities to take part in research and gain access to experimental treatments. For instance, some people live far away from traditional research sites, some people have limited access due to mobility issues, and some people have parental obligations, limiting their opportunities to participate in research away from home.&nbsp;<\/p>\n\n\n\n<p>By easing participation, generating more data, and increasing diversity, decentralized clinical trials can potentially increase medical innovation, produce more solid findings, and catch a wider range of adverse effects for diverse patient groups.&nbsp;<\/p>\n\n\n\n<p><strong>A Number of Challenges<\/strong><br>On the other hand, decentralized clinical trials also present a number of challenges. Firstly, while decentralized clinical trials may increase the diversity of research populations in some respects, it may also have the opposite effect in other aspects. For instance, people who are not familiar with or unable to buy the latest modern technology may find themselves with fewer and not more opportunities for research participation, which may not only be a problem in terms of equality but potentially also in terms of selection biases.<\/p>\n\n\n\n<p>Secondly, decentralized trial elements such as electronic consent processes take place in an environment where people are used to giving their consent without much consideration. Just think about the last time you skipped through the terms and conditions of a digital service. In the context of clinical research, that could become a serious problem.&nbsp;<\/p>\n\n\n\n<p>Thirdly, moving clinical investigations into a digital setting raises obvious concerns about privacy and data protection.&nbsp;Not only because health data is extremely valuable but also because data from decentralized clinical trials often move back and forth between many different countries and destinations, as such studies have no traditional research sites for data storage. The potential for breaches and leaks is relatively high.<\/p>\n\n\n\n<p><strong>New Guidelines and Laws Needed<\/strong><br>To navigate safely in this new landscape, we need clear guidelines and laws protecting research participants in decentralized trials. We need procedures for data protection and privacy enhancements. We need to use the same tools that we leverage for the benefit of clinical research to promote the (digital) rights of research participants. Otherwise, we risk losing valuable trust in science that has taken years to build up.<\/p>\n\n\n\n<p>We also need a closer collaboration and tighter integration between the traditionally separated fields of data and research ethics. In modern clinical investigations, traditional ethical issues e.g. in relation to recruitment, informed consent, and risks, are slowly becoming more and more entangled with issues concerning the collection, storage, analysis, and use of data. Addressing these issues requires insights from both data and research ethics.<\/p>\n\n\n\n<p>Finally, we need strong regulatory bodies with a sensitive approach to data ethics. Medical devices are moving online and clinical investigations are moving with them. Regulatory bodies, such as ethical review boards and monitoring agencies, need to move along as well to keep up with the current development.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Digitalization is changing the landscape of clinical research. Ushered in by the pandemic, so-called decentralized&#8230;<\/p>\n","protected":false},"author":39,"featured_media":12268,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[230,9],"tags":[3790,298,904],"class_list":["post-12267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogpost","category-latest-news","tag-clinical-trials","tag-ethics","tag-research-ethics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>When Clinical Trials Go Digital, Ethics Is Needed &#183; Dataetisk T&aelig;nkehandletank<\/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:\/\/dataethics.eu\/da\/when-clinical-trials-go-digital-ethics-is-needed\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"When Clinical Trials Go Digital, Ethics Is Needed &#183; Dataetisk T&aelig;nkehandletank\" \/>\n<meta property=\"og:description\" content=\"Digitalization is changing the landscape of clinical research. 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