But in recent years, there has been a move towards a more patient-centric model. What has changed for sites conducting decentralized clinical trials (DCTs) since 2020? Practical experiences of future proofing clinical trials using the decentralized approach. Recruitment costs can be sustainably lower due to participation through ePro, wearable devices and telehealth visits. The advantages of decentralized and hybrid clinical trials have been reviewed during the webinar and include the following: Patient centricity Trial access Adaptability of schedule of assessments Patient convenience and improved patient compliance Enrollment of a broader and more diverse study population Reduced burden to the site and patient Decentralized Clinical Trials In decentralized clinical trials, patient visits for healthcare provider interaction and laboratory tests are localized in the patient's community. Studies have revealed: 70% of patients live more than two hours from a research site CTTI Decentralized Clinical Trials ctti-clinicaltrials.org Page 8 of 17 sponsor. Designing and running a pan-EU pilot, comparing the scientific and operational quality of the DCT with . Designs that bring the trials to patients (e.g., decentralized clinical trials) that may include shipping the IMP to patients homes or local providers and data capture at home o Trials conducted within health care settings (e.g., trials with pragmatic elements), and o Trials that incorporate real -world data sources. Sponsors/CROs and any other party handling data should take specific actions to control and manage data flow, for example: Map data flow and data storage, starting with clinical trial source data, and The COVID-19 pandemic has challenged the industry to re-think traditional approaches to clinical trials, driving the space forward and ushering in an age of technology-driven opportunity that we . Amid Covid-19 and the resulting lockdown restrictions, removing the need for trial participants to attend central trial sites . With electronic devices available in most patient households and an increasing offering of dedicated decentralized solutions, many tasks in a clinical trial can now be performed digitally.Thanks to tools such as online questionnaires and video calls, clinicians and patients can stay in touch throughout the study, reducing the time . DCTs are the culmination of this trend - designing clinical trials based on patient needs, indication, and therapy. Join my colleague Kelly McKee in her Power of Partnership webinar with the Society for Clinical Research Sites (SCRS) to explore the challenges sites face when participating in DCTs, solutions sites have implemented, and more. The Main Benefits Of Decentralised Clinical Trials Decentralisation has the primary goal of making clinical trial participation as easy as possible, enabling participants to continue with their day-to-day lives with minimal disruption. The FDA is leading the way to new methodologies for conducting clinical trials and similar to what happened during the first months of COVID-19, EMA followed. By this is meant the use of digital tools (digital consent, electronic consultations, electronic data collection systems, wearables and other medical . While EMA is THE European institution, different countries still have the freedom to translate regulations in their own country in another way, so regulatory freedom is still there. European Union, United Kingdom February 8 2022. Decentralised Clinical Trial s (DCTs) are trials that use digital technologies to communicate with study participants, bring clinical research closer to patient's home and to collect study data. Decentralized Clinical Trials Risk Assessment Considerations Decentralized Clinical Trials Data Flow Maps Advancing DCTs ACRO members are dedicated to helping bring quality-based principles, risk-assessment tools, and patient-centricity to the decentralized trials process. As a result, Decentralized Clinical Trials reduce patient burden while increasing patient recruitment, retention, and inclusion. A decentralized approach leverages technology to provide savings in every aspect of the clinical trial. The European regulatory system for medicines (the 'EU network', or EMRN) is a network of all the national medicines regulators (human and veterinary) from EEA member states, the European Medicines Agency (EMA) and the European Commission. Clinical trials with medicinal products have made rapid advances when it comes to digitalisation and decentralisation. Decentralized Clinical Trials (DCTs) are studies that are supported by local or mobile healthcare providers that focus on bringing activities to patients instead of bringing patients to trial sites. ecentralized Clinical Trials (DCTs) can be an accelerator to increase patient diversity, recruitment, and engagement. Global Decentralized Clinical Trials (DCTs) Market valued at US$ 8.8 billion (2021) is set to witness a healthy growth rate of 10% to reach US$ 14.2 billion by 2026. Based on our knowledge of the new regulation, along with our years of experience helping our customers conduct global decentralized clinical trials, the following are our recommendations for how to successfully access and use the new Clinical Trial Information System (CTIS), a critical piece of the new EU regulation. definition of criteria to analyse each case study (either hybrid/fully decentralised) and report to build up the remote dct approach in eu review of previous case studies (remote decentralised clinical trials/home monitoring) available from industries and investigation sites (public/private) to date to define and share challenges and Mapping and analysis of the EU legislation on Remote Decentralised Clinical Trials including legal, regulatory, ethical and stakeholder recommendations for the conduct of the pan-EU pilot (D4.1) Lead Contributors: Yared Santa-Ana-Tellez, Utrecht University - Helga Gardarsdottir, Utrecht University February 26, 2021 - updated March 2022 129 When a computerised system is implemented by the institution where the investigator is conducting a 130 clinical trial, any reference to the investigator in this guideline also includes that institution, as provided Trials@Home aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe. Explore some of ACRO's additional DCT resources: Press Release The COVID-19 pandemic made decentralization not only a preference but also a necessity for many clinical trials globally whose operations were disrupted due to the complicated healthcare and logistical situation the pandemic caused. Trust our proven heritage in trial optimization and decentralization. Decentralized Clinical Trials: EU To Demystify Differences Between Member States A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country. Benefits of DCTs, Covid-19, growing adoption by pharmaceutical, medical device companies & contract research organizations (CROs), formation of industry stakeholder groups such as Decentralized Trials & 2.3. Decentralized clinical trials also give sponsors the ability to collect more complex and real-time data via remote monitoring and to combine this with other clinical trial dataall integrated into a single EDC system. These methods include patient-centric trial flexibilities such as electronic informed consent, virtual clinic visits, delivery of investigational product to the home and obtaining laboratory or. In a November survey of clinical trial professionals conducted by Oracle Health Sciences, 76% of respondents said the pandemic has accelerated adoption of decentralised trial models, while 38% reported that more than half of their trials had already been decentralised. Mrta Segerdahl, Chief Medical Officer at AlzeCure Pharma AB. Gain leading industry perspectives from AbbVie, Roche, Swedish Medical Projects Agency. 128 extent that a CRO has assumed the trial related duties and functions of a sponsor (ICH-GCP 5.2.4). the EMA and other regulators. Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants' homes and local surroundings. The guidance was agreed by the Clinical Trials Expert Group (CTEG) of the European Commission, supported by EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of HMA and the GCP Inspectors' Working Group , with the aim of ensuring the utmost safety of trial participants across the EU while preserving data quality. Decentralized clinical trials (DCTs) have been defined as patient-centric studies executed through telemedicine and mobile/local healthcare providers using processes and technologies differing from the traditional clinical trial model. Minute Insight: Amazon Partners With Thread To Help Decentralize Clinical Trials Thread, a technology and consulting service provider, signed a deal with Amazon Web Services to enable faster, more efficient subject monitoring and data collection in clinical trials. For more than twenty years, Signant has pioneered the application of technology, scientific services, as well as project delivery infrastructure to optimize clinical evidence generation and remote clinical trial conduct. In May 2020 Clinical Trials Europe conducted a study of clinical trials professionals around the world, and based on 184 responses, this final report reveals unique insights into the use of virtual, decentralized and hybrid trials today, strategy for adoption in the future, and the challenges that still need to be overcome. Historically, clinical trials focused on the top 3 KPIs: recruitment, retention, and protocol compliance. Learn More. Decentralized Clinical Trial providers faced extreme pressure from sponsors to quickly decentralize trials and allow for procedures to be completed outside of the traditional site setting with unlimited customization. By doing this, we have supported 28% of recent novel . This unique system serves a population of over 400 million people. 3 Source: EMA's road map to 2015. Decentralised clinical trials (new) New: Decentralised clinical trials aim to facilitate participation in trials by offering maximum flexibility and convenience, for instance by enabling participants to receive home health visits and study medicine shipments and to provide their consents electronically. Decentralized clinical trials (DCTs) focus on bringing an increasing proportion of a trial's activities to the patient's home, as opposed to . . Denmark Outlines Vision For Decentralized Trials Beyond COVID-19 What is a decentralized clinical trial? In this study, we conducted semi-structured interviews with 20 European regulators to identify regulatory challenges and opportunities for the . DCTs reduce burden on participants and offer a patient-centric approach to clinical trial management that differs from the traditional model. Some sites had a back-up plan, others needed full support, so DCT providers were forced to accommodate multiple approaches. Decentralized Clinical Trials. By expanding the number and nature of datapoints, DCT studies can generate a complete picture of the patient experience. Discussing the new decentralized clinical trial European Guideline and the regularity viewpoint from the MHRA. 4 DCTs were designed to augment or replace traditional in-clinic approaches with direct-to-patient (DTP) and data-driven alternatives, with an emphasis on in . Medications for the study are provided either directly to the patient or the local healthcare facility. 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