Decentralized Clinical Trials | 九色 Life Sciences
This is the second of a two-part series on our recent
九色 Life Sciences held C3 Summits in Princeton, NJ; Raleigh, NC; and London, England, where multiple subject matter experts came together to discuss clinical content. Throughout these events, we focused on two key topics that are relevant to the greater life sciences industry: diversity in clinical research and decentralized clinical trials (DCTs). Check out our blog on diversity in clinical research.
Our Raleigh and Princeton sessions invited experts in the clinical space to share their perspectives on the existing landscape of decentralized trials, challenges and opportunities, and future states. Check out our key takeaways from these sessions that include leveraging technology to enable patient engagement, managing global rollout of DCTs, and exploring the patient/stakeholder experience.
What Are We Trying to Solve for in the Use of Decentralized Clinical Trials?
How easy is it for a patient to participate in a study? In certain cancer trials, for example, only participate, with this number shrinking even further in the case of rare diseases. Oftentimes, this is due to limited proximity to research sites. Empowering patients by removing the logistical burden of distance, receiving treatments, etc. makes locating the right patients less complex through the implementation of DCTs.
Leveraging Technology to Facilitate an Approach to Decentralized Clinical Trials
With technology, we have new, thoughtful ways to measure and validate different data points. This ease of access to technology empowers patients to share the areas in which they reap benefits from treatment in their day-to-day life without relying primarily on on-site testing and endpoint validation. The types of technologies leveraged for DCTs provide the opportunity to measure endpoints that are more impactful for the patient. For example, patients with express more value in increased mobility in their day-to-day lives compared to an on-site, six-minute walk test.
At present, there is an abundance of technologies capable of collecting direct patient-input data points at an exponential rate. It is then up to the sponsors to decide how to filter the relevant data. However, there are concerns surrounding changing endpoint perspectives with regulatory bodies such as the and , and how the data will be evaluated and leveraged from a regulatory perspective.
Additionally, in the case of multiple coordinators at multiple sites being trained differently to conduct testing such as the a number of variables need to be controlled, and standardization of these measurements is critical.
Technical Challenges/Hurdles to Decentralized Clinical Trials
Integrating data and having it cross-checked is half the battle. In theory, it would be beneficial to assign a centralized study coordinator to teach patients different aspects of the technology and how to properly conduct independent data collection, such as self-administered ECGs, blood draws, etc. However, there are complexities associated with validating the action and ensuring the data was collected correctly. There is currently no assigned authority to triage the data collection, presenting logistical issues and increasing the possibility for error (e.g., in the case of a patient performing a blood-draw that is then found to have been collected insufficiently upon lab retrieval).
Access to patient information is also a concern. Traditional trials implement a firewall at a site designed to securely collect and retain patient identifiers, such as names, addresses, phone numbers, etc. During these trials, a study coordinator handles all communication while sponsors communicate with the site. In the case of DCTs, similar firewalls need to be established to collect this information in compliance with GDPR and other regulatory requirements depending on site location(s).
Digital technology, wearables, etc. create a new, real-world data collection methodology (e.g., sensors monitoring for adverse events enable patients to return home while continuing to monitor). However, concerns arise when considering how tool-generated data need to integrate and be stored with all other data. In this case, many sensor clouds become “data dumpsters,” making it difficult to source the important data once it is all collected and stored.
Patient and Stakeholder Experience
Patients are not a monolith. It is important to consider the nuances of patient preferences and individual journeys in the early stages of trial design. The concept of optionality is already a standard with the evolution and maturation of engagement strategies in most other areas of daily life. Some patients may not be comfortable with having researchers visit their homes and would prefer to travel to sites. For others, this is an enormous ask hindered by logistical concerns and scheduling issues, such that they would prefer to participate remotely.
In terms of technological enablement, many complexities are associated with bringing technology directly to the patient. Software and instructions must be easy to use and accessible; a “consumer-grade experience” is necessary for all applications and devices. It is essential that patients can access specialized support at all times to ensure applications and devices are correctly handled.
With all of the above considered, it is ultimately important to foster patient centricity as early as the trial design phases. This involves collecting patients’ insights by talking to and connecting with real people. It takes time to identify patients and foster relationships where they are comfortable discussing their lives and backgrounds. DCTs provide opportunities to reach patients faster, unhindered by location, and enable researchers to work in countries where they can become contracted with patients faster. This affords more time to foster these connections and discuss the patients’ concerns and goals rather than making assumptions.
Global Rollout: Challenges Faced with the Deployment of Technologies in Different Regions of the Globe
With multiple team members receiving the same data, intelligent orchestration of roles and responsibilities must be required to ensure seamless communication and visibility at a regional level. It is critical to have a single source of truth across multi-channel systems to filter that data to the appropriate team member to handle as required.
Furthermore, monitoring DCTs on a global scale invites a conversation about risk. Evaluating failure modes as soon as they occur enables researchers to automate monitoring and present it to the right individuals in the correct format. For example, electronic investigator site files facilitate total visibility into all documentation without the need for multiple presentations. However, despite enthusiasm for the risk-based monitoring approaches, many are having difficulties separating from source data verification (SDV).
In terms of patient privacy protections, there is a level of apprehension toward moving to virtual clinical trials. Concerns surrounding patient validation create contentions with patient privacy concerns and their willingness to provide private information electronically. However, tools are available to optimize security to preserve patient privacy, such as role-based access to electronic investigator site files.
Another issue with global rollout is a lack of specific country guidelines on how to navigate additional country-specific components regarding wider regulations (e.g., data protection agencies in different EU member states can have their own requirements in addition to the general EU GDPR regulations). In APAC, almost every region has a local ethics committee with their own set of standards that must be followed, which can become challenging in terms of regulatory compliance.
Future of Decentralized Clinical Trials
In the future, the implementation of DCTs is not necessarily as complex or intangible. For example, with pharmacies as an investigative site, vaccine trials could be made almost 90% decentralized beyond the initial trip to receive each dose. Once the patient has received the vaccine, they can leverage at-home testing and send feedback to the site where the vaccine was administered. This requires greater buy-in from providers to become more widespread.
Presently, there are initiatives underway within the EU and the EMA to educate and counteract bias among stakeholders. Still, reservations exist about the use of technology and ensuring a robust data protection framework. Insofar as technological enablement of DCTs, it is expected that AI will be integrated to handle heavy lifting in terms of processing data input (e.g., patients can leverage mobile apps to run their own ECGs, which will then report back to the cardiologist automatically and flag for ab90%ities).
We will begin to see the involvement of more niche, innovative technology providers with specific expertise to help fill technological gaps in DCTs. It remains to be seen how different providers will approach these partnerships, but it will ultimately be a convergence of expertise.
Conclusion
If you are curious to learn more about DCTs and leveraging technology to maximize clinical outcomes in DCTs, to discover how 九色 can support and enhance your research initiatives.
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