{"id":28222,"date":"2022-06-30T09:08:39","date_gmt":"2022-06-30T14:08:39","guid":{"rendered":"https:\/\/saluddigital.com\/?p=28222"},"modified":"2025-10-20T11:37:02","modified_gmt":"2025-10-20T17:37:02","slug":"la-importancia-de-los-ensayos-clinicos-descentralizados-durante-la-pandemia","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/comunidades-conectadas\/la-importancia-de-los-ensayos-clinicos-descentralizados-durante-la-pandemia\/","title":{"rendered":"The importance of decentralized clinical trials during the pandemic"},"content":{"rendered":"
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Decentralized clinical trials offer great benefits as they promote more diverse research, reduce costs, and also avoid risks of exposure to diseases such as COVID-19.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Due to the COVID-19 pandemic, the application of clinical trials was considerably reduced, therefore the decentralized clinical trial modality was the most appropriate to continue these activities during the health emergency.<\/p>

Clinical trials are one of the most reliable methods to generate scientific evidence in new therapeutic approaches: However, when these trials must be carried out on a large scale, it is necessary for the participants to go to a data collection center with the specialists. This generates operational and time costs for both parties, participants and researchers.<\/p>

A large part of the clinical trials do not reach their enrollment goals in a timely manner, and in addition the pandemic has further restricted this type of method. Therefore, the best option to improve enrollment rates in clinical trials, as well as reduce costs, the most viable option is decentralized clinical trials.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\u201cDecentralized trials generally refer to trials in which recruitment and data collection procedures are not restricted to fixed locations. Participants can perform the testing activities where they are, including at home, using remote technologies, potentially heightening engagement and enhancing the study participants' journey," explain the authors of the Pandemic-Proof Recruitment and Participation study at a fully decentralized trial in patients with atrial fibrillation (DeTAP) published in npj Digital Medicine.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Unlike traditional trials, new decentralized trial protocols can speed up recruitment of participants. Also, thanks to new technologies it is possible to carry out remote studies. \u201cRapidly emerging digital health technologies can help remotely obtain the objective physiological data that cardiovascular trials often require,\u201d the study explains.<\/p>

The aforementioned study sought to validate the feasibility of a completely virtual decentralized clinical trial for cardiovascular interventions. Since no trial of this type, in phase 3 and on a large scale, has used a completely decentralized protocol and that includes physiological measurements obtained remotely.<\/p>

Traditional recruitment for that study yielded only six participants, as opposed to the more than 400 participants recruited through social media tools. In 12 days, recruitment through social media advertising managed to enroll 94 participants and more than 300 eligible patients on the waiting list.<\/p>

Ultimately, the study succeeded in reporting the feasibility of fully decentralized and potentially scalable cardiovascular intervention trials that included remote physiological monitoring among patients with atrial fibrillation, with strong virtual recruitment, strong commitment, and successful monitoring of oral anticoagulation adherence.<\/p>

In this way, the study presents a basis that may be useful for the development of future protocols to carry out decentralized trials specialized in cardiovascular monitoring.<\/p>

Learn more at: https:\/\/www.nature.com\/articles\/s41746-022-00622-9<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

NATURE <\/strong><\/p>

https:\/\/www.nature.com\/articles\/s41746-022-00622-9<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Los ensayos cl\u00ednicos descentralizados ofrecen grandes beneficios ya que promueven una investigaci\u00f3n m\u00e1s diversa, reducen costos, y adem\u00e1s evitan riesgos de exposici\u00f3n a enfermedades como COVID-19. Debido a la pandemia de COVID-19, la aplicaci\u00f3n de ensayos cl\u00ednicos se redujo considerablemente, por ello la modalidad de ensayos cl\u00ednicos descentralizados fue la m\u00e1s adecuada para continuar estas actividades durante la emergencia sanitaria. Los ensayos cl\u00ednicos son uno de los m\u00e9todos m\u00e1s confiables para generar evidencia cient\u00edfica en nuevos enfoques terap\u00e9uticos: Sin embargo, cuando estos ensayos se deben realizar a gran escala, es necesario que los participantes acudan a un centro de recopilaci\u00f3n de datos con los especialistas. Esto genera gastos operativos y de tiempo para ambas partes, participantes e investigadores. Gran parte de los ensayos cl\u00ednicos no alcanzan sus objetivos de inscripci\u00f3n en tiempo y forma, y adem\u00e1s la pandemia ha restringido a\u00fan m\u00e1s este tipo de m\u00e9todos.  Por ello la mejor opci\u00f3n para mejorar las tasas de inscripci\u00f3n a ensayos cl\u00ednicos, as\u00ed como reducir costos, la opci\u00f3n m\u00e1s viable son los ensayos cl\u00ednicos descentralizados. \u201cLos ensayos descentralizados se refieren en t\u00e9rminos generales a ensayos en los que los procedimientos de reclutamiento y recopilaci\u00f3n de datos no est\u00e1n restringidos a ubicaciones fijas. Los participantes pueden realizar las actividades de prueba donde est\u00e1n, incluso en casa, utilizando tecnolog\u00edas remotas, lo que potencialmente aumenta el inter\u00e9s y mejora el viaje de los participantes en el estudio\u201d, explican los autores del estudio Reclutamiento y participaci\u00f3n a prueba de pandemias en un ensayo totalmente descentralizado en pacientes con fibrilaci\u00f3n auricular (DeTAP) publicado en npj Digital Medicine. A diferencia de los ensayos tradicionales, los nuevos protocolos de ensayos descentralizados pueden hacer m\u00e1s r\u00e1pido el reclutamiento de los participantes. Asimismo, gracias a las nuevas tecnolog\u00edas es posible la realizaci\u00f3n de estudios remotos. \u201cLas tecnolog\u00edas de salud digital que emergen r\u00e1pidamente pueden ayudar a obtener de forma remota los datos fisiol\u00f3gicos objetivos que a menudo requieren los ensayos cardiovasculares\u201d, explica el estudio. El estudio mencionado busc\u00f3 validar la viabilidad de un ensayo cl\u00ednico descentralizado completamente virtual para intervenciones cardiovasculares. Ya que ning\u00fan ensayo de este tipo, en fase 3 y a gran escala, ha empleado un protocolo descentralizado en su totalidad y que incluya mediciones fisiol\u00f3gicas obtenidas de manera remota. El reclutamiento tradicional para dicho estudio logr\u00f3 solamente seis participantes, a diferencia de los m\u00e1s de 400 participantes reclutados a trav\u00e9s de herramientas de redes sociales. En 12 d\u00edas el reclutamiento realizado a trav\u00e9s de publicidad en redes sociales logr\u00f3 inscribir 94 participantes y m\u00e1s de 300 pacientes elegibles en lista de espera. Finalmente, el estudio logr\u00f3 informar la viabilidad de los ensayos con intervenciones cardiovasculares totalmente descentralizado y potencialmente escalable que incluy\u00f3 monitoreo fisiol\u00f3gico remoto entre pacientes con fibrilaci\u00f3n auricular, con un reclutamiento virtual s\u00f3lido, un fuerte compromiso y un seguimiento exitoso de la adherencia a anticoagulaci\u00f3n oral. De esta forma el estudio presenta una base que puede ser \u00fatil para el desarrollo de futuros protocolares para realizar ensayos descentralizados especializados en monitoreos cardiovasculares. Conoce m\u00e1s en: https:\/\/www.nature.com\/articles\/s41746-022-00622-9 BIBLIOGRAF\u00cdA NATURE https:\/\/www.nature.com\/articles\/s41746-022-00622-9<\/p>","protected":false},"author":1,"featured_media":28226,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[154,3401,160,3394],"tags":[145],"class_list":["post-28222","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunidades-conectadas","category-iotapps","category-noticias","category-redes-sociales","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/28222","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=28222"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/28222\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/28226"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=28222"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=28222"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=28222"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}