Decentralized clinical trials are clinical trials in which single or multiple trial-related activities take place outside the traditional study center. This can include teleconsultations, home visits by healthcare professionals, electronic informed consent processes, remote monitoring or the direct delivery of investigational medicinal products. They change the organization of the trial conduct, but not the fundamental requirements for participant protection, data quality and regulatory oversight.<\/p>\n
A decentralized clinical trial, often internationally referred to as a Decentralised Clinical Trial or DCT, is not a separate trial type of Regulation (EU) No 536\/2014. The European recommendation deliberately refers to “decentralised elements” and not to an exhaustive legal definition. In practice, most trials are hybrid: Certain examinations take place at the study center, while appropriate processes are organized closer to the place of residence or digitally.<\/p>\n
Possible elements are home visits by qualified healthcare professionals, teleconsultations, electronic information and consent, electronic diaries, remotely readable measuring devices, local examinations as well as the shipment of investigational medicinal products to participants. Whether an element is suitable depends on the protocol, intervention, safety profile, burden on the participants and the question of whether the data can be collected reliably.<\/p>\n
The use of digital or home-based procedures is not an end in itself. It is intended to make the trial more accessible for participants, without merely shifting burdens or risks to other stakeholders. In the design phase, participants, investigators and, if necessary, patient organizations should therefore be involved early on. Critical examinations or measures that require immediate medical infrastructure remain at the study center.<\/p>\n
Decentralized elements expand the interfaces between sponsor, investigator, study center, participants and external service providers. The European recommendation demands a clear assignment of which activity is performed where, when and by whom, and how oversight is maintained. A delegation of tasks alters neither the sponsor’s responsibility for safety and data reliability nor the investigator’s responsibility for the oversight of the trial conducted at the study center.<\/p>\n
For home visits, teleconsultations or technical platforms, qualification, training, communication channels and escalation procedures must be defined in advance. Participants must know whom to contact in case of acute safety questions, device problems or questions about home visits. Safety information must reach the investigator promptly so that adverse events can be evaluated and the intended reporting pathways are adhered to.<\/p>\n
Data collection via multiple systems also requires a robust data concept. Source, transmission, access, plausibility checks and corrections of electronic data must be comprehensible. For wearables, ePRO or telemedicine, the suitability of the systems, data protection, technical support and a procedure for failures or data gaps must be described in advance. Monitoring can be remote or central, but must be planned on a risk basis and ensure the meaningfulness of the data.<\/p>\n
Decentralized clinical trials must not be confused with the decentralized authorization procedure, the Decentralised Procedure or DCP. A DCT concerns the operational conduct of a clinical trial: It describes where and by what means trial-related activities take place. It can be used within a trial with one or multiple study centers and includes, for example, remote visits or home visits.<\/p>\n
The DCP, on the other hand, is a marketing authorization procedure according to Directive 2001\/83\/EC. It enables a coordinated evaluation of a marketing authorization application in several Member States if no authorization yet exists for the medicinal product. A Reference Member State prepares the assessment report, which the Concerned Member States review. The procedure consequently regulates the authorization of a medicinal product and not the spatial or digital organization of a clinical trial.<\/p>\n
Both terms can appear in the same development program, but have different functions. Data from a decentrally organized clinical trial can be part of a marketing authorization dossier. However, it does not follow from this that the trial was conducted according to the DCP or that a DCP requires decentralized study elements.<\/p>\n
Decentralized elements can facilitate participation, especially when long travel distances, restricted mobility or frequent follow-ups burden the conduct. Their benefit, however, depends on the specific trial. For clinical operations, realistic support for participants, qualified service providers, precise safety communication and the mastery of technical data sources are crucial, so that flexibility does not lead to protocol deviations or incomplete data.<\/p>\n
Full-service CROs such as Mediconomics support feasibility and study planning, the selection and management of study sites and service providers, monitoring, data management, pharmacovigilance and quality management. This also includes processes for electronic informed consent, home nursing, investigational medicinal product logistics, escalations and the documented oversight of decentralized study elements.<\/p>\n
Are decentralized clinical trials permitted in the EU?<\/strong><\/p>\n Decentralized elements can be used in clinical trials if they are compatible with the applicable requirements and ensure participant protection as well as data reliability. The European recommendation explains possible elements and at the same time points out national requirements that must be checked depending on the Member State.<\/p>\n Must a DCT take place completely without a study center?<\/strong><\/p>\n No. Frequently, only single activities are conducted decentrally. A hybrid model combines, for example, visits or examinations in the center with teleconsultations, electronic questionnaires or home visits. Which proportions are suitable is decided based on the risks and requirements of the respective protocol.<\/p>\n Is a DCT the same as the DCP?<\/strong><\/p>\n No. A DCT describes the conduct of clinical trials with decentralized elements. The decentralized procedure DCP is a procedure for coordinated marketing authorization in several Member States and has no relation to the question of whether study activities take place at home, digitally or in the study center.<\/p>\n Decentralized clinical trials are clinical trials in which single or multiple trial-related activities take place outside the traditional study center. This can include teleconsultations, home visits by healthcare professionals, electronic informed consent processes, remote monitoring or the direct delivery of investigational medicinal products. They change the organization of the trial conduct, but not the fundamental […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6733","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6733","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6733\/revisions"}],"predecessor-version":[{"id":7414,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6733\/revisions\/7414"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6733"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
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