This piece originally appeared in Pharmaceutical Technology.
The uptake of decentralized clinical trials (DCTs) solutions was greatly accelerated by the COVID-19 pandemic, with lockdowns necessitating that research be continued virtually and remotely with participants. Now in a post-pandemic world, while not suitable for all studies, DCT solutions are continuing to change the way sponsors and CROs manage their clinical trials.
Research by Zelta found that 89% of sponsors are currently using decentralized technology to support at least one of their trials. Before the advent of DCT solutions, participants in a study had to live within commuting distance of a trial site or invest in travel to participate, meaning that rural populations or those without adequate free time or resources to travel to the site were often left out of the research. DCTs have been hailed as a solution to these problems, utilizing electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA), as well as digital monitoring solutions, in-home nursing, and other in-home clinical services, to conduct trials remotely.
The increase of wearable health tech integrated with Bluetooth and Internet of Things (IoT) technologies can further improve the quantity and accuracy of clinical trial data, alongside boosting participant retention and reducing the overall cost of the trial. For example, in a Phase III cardiovascular trial, one Zelta CRO customer used remote blood pressure monitoring devices in a fully virtual trial to capture data from participants, which was then uploaded to the Zelta platform. Real-time data was collected from hundreds of people, eliminating the need to visit those participants individually or have them come to a site, resulting in a cost-effective and more efficient trial process.
For all their potential, there still remain difficulties in implementing DCTs. While sponsors might be tempted to stick with a centralized model or more traditional trial design, more complicated health conditions and large, diverse trial designs still benefit from DCT solutions.
Through a DCT, participants can provide data from anywhere in the world. Widening the participant opportunity could be especially helpful for research into rare health conditions with limited candidates. But sponsors and CROs may have concerns about the integrity of data collected remotely, as well as the intricacies of collaboration across a wide network of stakeholders, from technology providers to participants.
A hybrid approach with partially decentralized elements appropriately applied to optimize the trial’s quality and efficiency should become the norm for modern clinical trials. Facilitating this requires a robust yet flexible DCT platform and reliable data collection solutions for sponsors and CROs.
While DCTs have the potential to reduce costs over the long term by eliminating travel expenses and increasing data collection efficiency, they also require an initial outlay of capital to acquire the right solutions, and a thoughtful risk evaluation.
Trial protocol, site location, and study population must all be considered, as well as the range of data collected. Creating a single source of truth is especially important during a DCT, when data is collected from a variety of locations and by different partners – from sponsor to participant to site to CRO. All this information should be collated into a single database that can be referenced and accessed by all required parties. Platforms such as Zelta can provide such a solution, reducing processing inefficiencies so that all necessary data can be housed in a single repository and accessible to appropriate stakeholders in real-time.
Communication between stakeholders about data management is also key, in order to proactively identify any potential issues. To prevent inefficiencies like duplicate or missing information before a DCT begins, sponsors and CROs must agree on data management and data transfer plans. But the technology can’t do this alone; those responsible for directing the study must define their own data management parameters. The technology is another tool in your arsenal, not a silver-bullet solution. Once data starts being recorded, it can provide insight to act on and shape a trial as it progresses.
The right DCT software is essential for monitoring a trial’s progress and identifying any issues with the data as they arise. Zelta’s data visualization tools make it easy to determine whether a trial is on track, and flags potential discrepancies in the data that might not otherwise be registered.
GlobalData’s Clinical Trials Database shows that a plurality (28%) of clinical trials that were withdrawn between 2011 and July 2021 did so on account of low participant accrual rates. eConsent, ePRO and eCOA capabilities have become increasingly prevalent since the pandemic and have been highlighted as significant factors in combating participant drop-outs. eConsent simplifies trial jargon and enhances participant comprehension to encourage an overall greater number of participants. With Zelta, all this participant-produced data can be collected and verified in a single system.
When conducting DCTs across different countries, participant and site data collection forms or screens must also be translated into a native language so that participants have a full understanding of what they are volunteering for. With Zelta, participant and site forms or screens are available in over 75 languages and dialects so that different parties can easily understand and communicate with each other.
Once again, sponsors should use their own judgment when deciding whether to implement eConsent or not, in accordance with their national or regional regulations and trial design. Sponsors should also support the choices of individual participants and not enforce a 100% eConsent mandate, which requires a flexible solution that can support both eConsent and paper consent processes. Equally important is opening a dialogue with participants and sites through a feedback loop across the trial process and to its conclusion, to understand what worked and what could be improved for future trials.
At the heart of any successful clinical trial lies collaboration between CROs, sponsors, sites, participants, and researchers. When implemented correctly, digital solutions can facilitate dialogues between stakeholders and ensure all parties have access to accurate information. Not all clinical trials should become DCTs, but with the rising popularity of hybrid approaches, sponsors and CROs must choose the right solution partners to ensure they have total data transparency and accuracy during a trial. A tried and trusted platform such as Zelta can make all the difference in ensuring your remote and hybrid trials remain efficient and effective.