We have reviewed the final 2024 FDA guidance on Conducting Clinical Trials with Decentralized Elements (DCTs). While the general concepts are not new, the guidance clarifies many key points that impact the clinical trial experiences for sponsors, investigators, clinical trial industry supporters, and participants. The guidance provides recommendations and best practices for integrating decentralized elements in clinical trials, while ensuring regulatory compliance, maintaining data quality, and supporting participant safety.

The final 2024 guidance updates the Agency’s prior guidances on decentralized clinical trials and digital health technologies (DHTs), clarifying considerations for designing DCTs based on appropriateness of telehealth or in-person visits for trial participants, investigational products, medical conditions of the trial population, and use of DHTs. The current guidance maintains the focus on two overarching principles, participant safety and data integrity by incorporating responsibilities specifically related to DCTs for sponsors, investigators and participants.

The use of decentralized components, such as telehealth or home visits in a clinical trial reinforces prior FDA guidance on patient-focused drug development (PFDD), by allowing trial activities to occur in places where it is convenient for participants. This benefits both participants and trials by reducing participant burden, improving accessibility, and improving retention.

The guidance references participants use of their own digital health technology, often referred to as ‘Bring Your Own Device’ (BYOD), with the caveat that sponsors make provisioned devices available to participants who do not have their own, to ensure that participation is accessible for all potential participants. At times in the past, sponsors have questioned whether the FDA would accept data collected via BYOD when considering regulatory approval. By describing use of a participant’s own DHT in the final guidance, it is clear that the FDA considers data collected via BYOD acceptable (see also the 2023 FDA guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations).

While recognizing that DCTs may risk increased data variability compared to traditional site-based trials, the guidance highlights the need for a strong risk-based monitoring plan to maintain data quality. In a DCT, data integrity can be supported through robust remote trial monitoring plans to ensure compliance with study protocol conventions and best practices for data collection. This may include use of video to supervise remote visits and real-time access to study data and standardized reports/dashboards. While audio/video telehealth interactions do not need to be 21 CFR Part 11 compliant, all study data captured during the virtual visit must conform to these guidelines (Section J). In addition, site and de-identified participant access details (date/time, etc.) should be captured in a robust audit trail (Section J). Critically, participant data privacy and security must be ensured during remote visits/events in decentralized settings.

The guidance also states that training participants on study guidelines is an important element for successful DCT and may be provided by site staff or within the application (Sections A, B, C, D, and J). Furthermore, to improve data consistency and limit variability, protocols for DCTs should include specific instructions for where and how trial activities are to be performed.

Participants must adhere to recommended safety procedures when health/safety issues occur to document potential Adverse Events (AEs) when they are not at the study site. However, the guidance advises that it is helpful to collect real-time information from participants when event-triggering thresholds are exceeded. Safety monitoring plans should ensure that AEs, including those that are identified remotely, are documented, assessed, and addressed. The safety monitoring plan should also detail the type of information specifically collected using DHTs, how it will be monitored, what actions participants should take if something concerning occurs and how trial personnel should respond to electronic alerts (Sections B and I).

The implications for sponsors and vendors have expanded beyond the delivery of enabling technology to include a serious focus on staff training, all quality assurance processes and foundational quality management systems. These are areas where we have focused our attention to ensure compliance not just for audit but for successful trial execution.

Authored on behalf of Clinical ink by Yamamoto, R, Anderson, D, Bowen, C, & Barrasso, B

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Design for Success: Integrate DCT elements from the start

One of the primary challenges in implementing DCTs is attempting to fit decentralized technologies into a protocol originally designed without their consideration. FDA guidance emphasizes the importance of designing protocols with DCT elements from the outset. Sponsors and investigators need to evaluate whether the study design lends itself to a fully decentralized approach, and if not, consider a hybrid model. Clinical ink experts are available to consult on the protocol design, providing guidance on which DCT technologies might best support study objectives and enhance the patient experience.

Accessible Trials for All: Provide provisioned devices for inclusivity

Ensuring access to technology for all patient populations is crucial for the success of DCTs. FDA guidance suggests providing approximately 15% of the study population with provisioned devices as part of a BYOD solution. This approach addresses patients who lack access to smartphones and caters to those who may not feel comfortable using their own personal devices for clinical trial purposes. Robust user testing and comprehensive translation capabilities can further enhance diversity. Clinical ink recommends user testing to assess accessibility and usability for different patient populations. Our in-app translation tools make it easy to manage multiple translations, ensuring all patient populations can fully engage in the DCT experience.

Empower Sites for Patient Care: Define clear roles for sponsors and investigators

FDA guidance emphasizes the importance of defining distinct roles and responsibilities for sponsors and investigators. In addition, Investigators should have ready access to all patient records generated during the trial to enable informed decisions regarding patient care during the trial and after it has completed.

Meanwhile, sponsors should incentivize sites to meet regulatory requirements regarding patient records.

“Sponsors should assign a final site payment once all patient data has been downloaded to the site servers for ongoing review as needed if a concern arises regarding patient safety. This serves as a reinforcement for sites to prioritize this crucial step.”

Bill Barrasso, Chief Compliance Officer, Clinical ink

By clarifying the roles of each party, sponsors ensure their sites are empowered to provide optimal patient care. Clinical ink technology facilitates connectivity between sites and patients, reducing site burden while providing them the tools and services to meet regulatory requirements.

Prioritize Patient Safety: Implement proactive Adverse Event (AE) reporting

Patient safety remains the top priority in DCTs. The recent FDA guidance advises having a clear plan for AE reporting, including instructions for patients to directly contact site personnel or emergency medical staff if needed. Clinical ink recommends incorporating patient instructions in e-diaries to remind patients to promptly communicate any worsening conditions to their healthcare provider.

Ensure Regulatory Compliance: Meet 21 CFR Part 11 standards

Clinical Ink technology is compliant with 21 CFR Part 11, which is mandatory. Clinical ink employs robust security measures, manages training, and processes to ensure compliance at every stage of the study.

Clinical ink has extensive experience, supporting more than 75 global DCTs. Our technology, services, and clinical expertise align with the regulatory guidance, providing our clients with the tools and support to conduct successful DCTs. It is important to remember that while technology can help facilitate the operational aspects of DCTs, it is the human element, prioritizing patient safety while adhering to regulatory guidelines, that remains key in achieving successful DCT outcomes.

For more information on solutions for DCTs, download our whitepaper, “A Prerequisite for More Flexible Clinical Trial Designs: an Integrated eSource Solution.”

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“McKesson Ventures is excited to invest in Clinical ink, a market leader in clinical trial enablement technology. Clinical ink’s innovative eSource solutions are particularly well-positioned as the industry shifts to more decentralized trials and remote monitoring,” said Dave Schulte, senior vice president and managing director of McKesson Ventures. 

Clinical trial sponsors can now choose deployment modalities to suit their protocols and patients, rather than having technology drive the selection. Despite the higher complexity this flexibility might suggest, ePRO+ still supports the rapid system implementation Clinical ink is known for, with study builds now less than 30 days, including translations. 

“As the eSource pioneers with tens of thousands of site-user interactions behind us, we know our solutions must be adaptable to patients’ and sites’ day-to-day realities,” said Clinical ink CEO Ed Seguine. “A unified, flexible, patient-centric solution helps patients consistently contribute the data that sponsors need, giving confidence in the data integrity, whatever the trial design. McKesson Ventures’ investment further validates the need for, and opportunity represented by, these technologies.” 

Lunexis ePRO+ is part of an eSource ecosystem that simplifies sponsors’ and CROs’ real-time data collection workflows, enabling study teams to confidently make critical study decisions. Sponsors stand to gain higher quality data as more actively engaged patients and sites enter information more efficiently according to protocol. 

Lunexis ePRO+ does more than just simplify data collection; TransPerfect Translations has partnered with Clinical ink to completely reimagine and simplify the complex translation process. “The novel way translations are handled in Lunexis ePRO+ alleviates inefficiencies in the feedback process and condenses the typical ePRO translation workflow and timeline, which can be considerable,” said Alexandra Crane, senior director, global head of COA solutions & implementation at TransPerfect. 

These advancements for streamlining and optimizing operational execution anticipate the rapidly changing needs of the clinical research industry. Mixed-modality capabilities, associated changes to the clinician-reported outcomes (ClinRO) feature set, and time-saving, unified authoring allow for extreme flexibility and are ideal for a wide variety of physical, virtual, and hybrid clinical trials. By harnessing this vision and years of experience, this launch builds even more momentum and positions Clinical ink to continue in its role as industry leader well into the future. 

Learn more about Clinical ink’s Lunexis ePRO+: Visit clinicalink.com/technology/ecoa/. 

About Clinical ink
Clinical ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Visit clinicalink.com. 

About McKesson Ventures
McKesson Ventures is a strategic venture firm backed by McKesson Corporation focusing on early and growth stage health technology and healthcare services companies. McKesson Ventures targets companies that both catalyze and benefit from the key changes taking place in the U.S. healthcare landscape. McKesson Corporation is a healthcare services and information solutions company dedicated to making the business of healthcare run better. Visit www.mckessonventures.com to learn more. 

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