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Data Management Considerations for Decentralized Clinical Trial Implementation
- 1. Decentralized Clinical Trials: Overview and Considerations
- 2. 2 Our Presenters Krista Bossi Senior Manager Clinical Data Management Ronelle Adlem Senior Manager Clinical Data Management Doreen van Huyssteen Associate Director Clinical Data Management Have questions for our industry experts? Please share them in the chat to participate in the live Q&A at the end of the presentation.
- 3. 3 Agenda • Introduction • Decentralized Clinical Trial Methodologies • Benefits of Hybrid/Full DCT Study Designs • DCT Platform Capabilities • Conclusion
- 4. Introduction
- 5. 5 Introduction • DCT – Decentralized Clinical Trials. Trial designs that support less physical interaction with participants and more virtual support through various technology platforms • Telehealth – Virtual consultations with health professionals allows long-distance patient and clinician contact, care, advice, reminders, education, intervention, monitoring, and remote admissions • ePRO/eCOA – Electronic Patient Reported Outcomes/Electronic Clinical Outcome Assessments. Questionnaires that can be completed remotely by participants or practitioners through web/app-based technology • eConsent – Electronic Informed Consent. Remote consent/assent signed by trial participants
- 6. 6 Decentralized Clinical Trials • Traditional site visits as well as remote telehealth/in-home visits • Drug supply usually done at scheduled on-site visits • Remote and on-site assessments Hybrid • Remote telehealth visits with no on-site consultations • Direct to patient drug supply • Remote assessments through wearables and devices • Remote sample collections Full
- 7. Decentralized Clinical Trial Methodologies
- 8. Study Design Considerations 8 Just because you can, doesn’t always mean you should!! • Therapeutic Area and complexity of visit assessments • Targeted age group and technology barriers • Licensing requirements and validation timelines for remote applications • Evaluate if DCT will enhance patient compliance, shorten timelines and decrease site burden • Regulatory Requirements/Risk Assessment • Infrastructure and regional challenges – Internet connectivity, power interruptions, high theft regions where device provisioning/replacement can be a concern • Vendor selection and Validation for remote assessments
- 9. Planning and Other Considerations The protocol, investigator plan and/or study document should provide detailed descriptions of the trial. Other Pre-trial Considerations: 9 Contracts Training Data Audits Vendors
- 10. Risk Assessment • Investigator and sponsor responsibilities do not change • The risks to the quality and integrity of the study and the data that’s being collected lie within the sponsor and investigator responsibilities • Risk Assessment needs to be undertaken by the sponsor and particular risks must be identified 10
- 11. 11 Dialogue/Early Engagement With Regulators Early planning and designing of the trial, the sponsor should discuss the approach to be used with the Agencies: • MHRA: Innovative Licensing & Access Pathway (ILAP) / Innovation, Scientific Advice meetings • FDA: Pre IND (Pre-Investigational New Drug Application) meeting • HC: Pre-application meeting with the Review Directorates, GCP requirements can be discussed with Compliance & Enforcement Unit
- 12. Benefits of Hybrid/Full DCT Study Designs
- 13. 13 Benefits • Patient Centric approach – ease of participation/better retention • Enhanced recruitment – not limited to geographical locations, travel implications and time constraints. • Diversity in study population – improves research quality • Less travel and subsequent lower cost • Reduced site burden
- 16. 16 Platform Considerations • Electronic Data Capturing platform options with DCT capabilities to suit the study design requirements • Modular approach allows flexibility to only use and pay for what you need • Technical support – System functionality as well as study specific requirements • Integration capabilities to accommodate wearable and device data transfers etc. Telehealth ePro eConsent Device Provisioning Remote Monitoring Redaction tools API Full/Hybrid eSource Technical Support
- 17. 17 eConsent Allows patients to understand trial objectives while providing consent through multimedia technology onsite or remotely. • Automated process – reduced consent errors • Patient friendly – Easy to understand clinical trial information • Comprehension Checks – enhanced compliance • Consent Tracking • Remote Monitoring Toolkit Video Uploads Quiz Embedded Documents
- 18. Scheduling • Ensure questionnaires are not completed in advance etc. ePRO/eCOA 18 Standard Library • Reduce build/UAT effort • Expedited timelines Licensing support • Paper/Electronic, both? • Requirements • Costing Validation • Independent provider • Internal/external Web/app based • BYO Device • App for provisioned device Translations • Provide questionnaire in local language for enhanced comprehension • Support multiple languages PHI protection • Rights and Role based Immediate data transfer on submit • Real time data transfers • Reduce site burden
- 19. 19 Conclusion • Decentralized Clinical Trials compliment certain study designs but do not fit all Therapeutic Areas • Functionality requirements need to be considered when selecting the EDC/DCT platform – Not a one size fits all • Licensing and validation timeframes can play a big role in DCT database design and release to production • Close collaboration between Data Management and Clinical Operations is now more important than ever
- 21. MMS Expert Insights Webinars The Expert Insights webinar series offers learning opportunities related to current industry trends, best practices and emerging areas or innovations occurring in the pharmaceutical, biotechnology, and medical device industries. Upcoming Webinar European Union Clinical Trial Information System (EU-CTIS) & Clinical Trial Transparency November 15, 11 AM - 12 PM EST Quick registration at: mmsholdings.com/webinars “Our leadership supports continuous learning of our colleagues and increased engagement with our sponsor partners.”
Editor's Notes
- Add in a section for Doreen van Huyssteen
- Doreen
- Doreen
- Ronelle
- Impact of COVID pandemic for DCTs: Forced many traditional trials to use or increase DCT components – Hybrid TA & visit assessments: can it be sent directly to the patient – and it needs to be tracked, and there will be significant challenges for IP that need be cold/refrigerated; there could be in-person visits for training the participants (i.e. how to administer study drug, blood draws etc.) as well as the use of telemedicine (i.e. remote diagnosis and treatment) Visits: the protocol and the schedule of assessments must clearly detail which contacts with the trial participants are physical visits at the clinical site, telephone contact, video contact, home visits or a visit to a local laboratory or the like. It should be clearly noted if there are different options available to the trial participant for each specific contact Participants: potential patient impairments (colour-blind, blind, deaf etc.) need to consider how tech savvy participants are… what training will they need, can they continue independently, i.e. will they be able to contact a helpdesk if they run into technical issues with a device, are they comfortable not having/limited face-to-face interactions Licensing: consider timelines, need to be in place prior to study start. Evaluate DCT: Patient impact (recruitment / retention and/or compliance) Regulatory: guidance for countries included need to be reviewed and ensure relevant technologies are used in line with applicable data protections. IT: Systems/IT solutions suitable documents/evidence in place that technologies have been validated.
- The protocol, investigator plan and/or study document should describe the: -All electronics systems used in the study -Roles and Responsibility of all stakeholders -Validation, UAT, back-up, licensing of applications as well as device provisioning -Drug accountability and compliance: procedures must be in place for keeping account of the IMP and controlling the compliance of trial participants. -Sponsor must discuss/justify each individual decentralised contact in the protocol. Contracts, agreements between stakeholders and 3rd party providers: should be in place prior to DCT implementation including the Data flow expectations, i.e. if source data are transcribed/manually entered in the EDC System or transferred via an automated system-to-system level exchange as well as whether external data that are transferred to the EDC system (and process for transferring the external data) Training: Investigators and sites need to be trained in DCT process and use of DCT technologies; Trial participants need to know what to do. Data: how the data will be stored, secured and tracked; access to data for review (DM, site, participant, CRA, PM, PI etc.); participant interactions with investigators, health care professionals, call centers, video telemedicine interactions etc. / Source data including external data transcribed or manually entered in EDC system vs transferred via an automated system. Audits: clear documentation in place e.g. data flow from source to report (incl. data locations, data, date, data handlers etc.), data protection and data access, who owns the data, training, how are AE/SAEs managed from technologies, how are participants supported etc. -Consider using specialist vendors for drug shipments to ensure IP stability is maintained and confirmation is obtained of delivery. -Arrange for compliance and drug accountability reporting.
- ---Clear risk assessment must be in place for all DCT trials Potential risks associated with DCTs - Regardless of the approach, the investigator and sponsor responsibilities do not change… patient safety remain the most important consideration! Protocol: can the endpoints be measured remotely, what if there is a need for specialized equipment that is not available to the pt at home, e.g. MRIs, scans - Electronic Consent: should be various options, e.g. via phone or video; there needs to be a witness present, yet the method used must comply with privacy requirements and it should be documented and approved by the IRB and IEC. Resources: need to consider potential challenges with medical oversight, delegation and training; Digital Data Collection Tools: they need to be validated through UAT (participants are unlikely to tolerate excessive issues/bugs … that could even result in early withdrawal); training will be required for participants on how to use these tools…
- Ronelle
- At MMS, we offer various platforms to support fully Decentralized trial design as well as Hybrid solutions using a modular approach. We partner with platforms that offer the best technology and support through industry experience and constant enhancements to support the next step in clinical research. Doreen
- Doreen – Krista will take us through most commonly used modules in both Full and Hybrid DCT solutions.
- Krista
- Krista
- Krista