Embedded and agile–The next phase of the DCT evolution

Darlene Ellenor
Director of project operations
decentralized clinical trials operations
ICON

There is a strong reported appetite for hybrid or fully decentralized clinical trials (DCTs) across industry stakeholders from patients to regulators and sponsors. In 2020, the DCT and digital boom coincided with the COVID-19 pandemic as the industry found operational solutions to travel restrictions and closures. At ICON, we saw an increase in the number of requests from sponsors for DCT proposals at that time, though there has been a slight taper in DCT uptake in recent years as we collectively ‘return to normal’ and the pressure to implement decentralized components slackened.

Despite the dip, DCT is here to stay. In fact, it is evolving for novel uses deployed in fit-for-purpose, flexible designs with impacts across study phases and indications. We have seen the benefits to patients and sponsors but are now moving forward with more thoughtful implementation strategies that can capture the true value of these tools and methods.

A solution, not just a trend

DCT is not just a trend, it’s an avenue for custom, tailored solutions that meet important needs at multiple levels, from operations to patient experience. ICON conducted a Patient Voice Survey in 2021 that captured pivotal data from 3,800 respondents across North America, Europe and Japan that highlighted several ways that decentralized trials benefit patients.

A primary burden for patients in clinical trial participation is travel, and 90% of survey respondents were willing only to travel less than one hour to participate, but 59% said they were more likely to participate if they received support to help coordinate travel and logistics. Patients also noted a strong preference for technology options compared to analogue or paper diaries. The survey results showed patients want options that allow trials to fit into their lives more conveniently. A 2022 research survey from TransCelerate and the Centre for Information and Study on Clinical Research noted that 79% of clinical trial participants indicated that having options improved their clinical trial experience.

The benefits to patients are also shared with site staff, supporting a symbiotic relationship, especially in key therapeutic areas. ICON survey results show the areas where DCT most benefits patients include cardiology, infectious disease and neurology, which shows strong parity with the areas where DCT most benefits staff, which includes cardiology, infectious disease and endocrinology.

Building from patients to sites to sponsors, the benefits and efficiencies can compound. As an extension of the benefits to patients, data-informed, feasible and patient centric DCT components can save time and resources by honing in on the most relevant and impactful solutions. Our 2023 poll of internal Account Directors, VPs and GPs working with top pharma and biotech reflected higher-level adoption of the value of DCT. Respondents noted 25% of the companies they have relationships with have established DCT corporate goals and more than half are considering adding them.

Valuable components

The DCT components being utilized by sponsors have changed in recent years as priorities shift and sponsors seek optimized operations. We have seen challenges around data integrity and integration as sponsors experience quality issues with technology vendors.There has been a steady increase in requests for concierge services to support patients and the appetite for wearables and digital health technologies have remained constant.

These trends reflect sponsor desires to streamline and optimise efficiencies while supporting patients. Not every protocol is necessarily suitable for decentralization and associated trial design is not a one-size-fits-all solution. We see sponsors taking a more purposeful approach with DCTs, and we consult with them to design an agile, intentional strategy that maximizes the potential value for the program.

Proven benefits of thoughtful implementation

A successful DCT implementation requires a balanced, multifaceted approach that provides the optionality patients want to keep them engaged from recruitment through the trial.Patients are not a monolith – optionality for in-person or community site visits and opportunities to build relationships with healthcare providers are still important to many patients. This is an area for consideration when determining which DCT components to use in trial designs and has previously been too often overlooked.

With tailored, multifaceted DCT strategies that centre the patient experience, we have seen irrefutable benefits to both patients and clinical study success. For example, individual case studies from our own trial experience have shown the following results:

• 10% improvement compared to traditional enrollment rates
• 90% retention rate with Concierge Services, 97% with in-home health services
• 400% improvement in diversity when DCT was leveraged as part of a multitiered operational strategy
• 95-99% improved compliance with ePROs
• Accelerated enrollment speed from 28 days to less than 7 days

Areas of focus for successful DCTs

As decentralized clinical trial models evolve to be more embedded in business-as-usual clinical trial operations, there are a few key points for consideration that will help set the program up for success. First, for global studies, it’s important to note that only 10% of countries have dedicated regulation for DCTs though we expect more guidance and regulation in the near future. The existing guidance varies between countries and special attention should be paid to eConsent/eSignature, concierge services, direct to patient shipping and home health services to ensure these components remain compliant across the study footprint.

Taking steps to ensure data integrity will continue to be important as data sources diversify and specialise in the market. DCTs must ingest health data in near real-time to support risk management, safety surveillance and reporting and timely, actionable decision-making. Visualizing trends in data is crucial to identifying potential risks or opportunities that impact decisions at key development stages. This is especially true for fully decentralized trials as it becomes even more imperative to act on any risks trending in the data before they become an issue that could jeopardise the trial’s endpoints. We utilise a Digital Risk Evaluator for this express purpose, because as data becomes more integral to study design, monitoring and evaluating the data flow and quality as it is ingested will continue to be a priority.

Sponsors will also need to consider the limitations in vendor digital technology platforms and datasets and the levels of integration required for each as this will impact quality and feasibility.

Embedded approach for an agile future

Sponsors just starting their DCT journey or those wanting to take DCT implementation to the next level may need to invest in the structures that support these programs. Specifically, change management is one of the main areas that sponsors need to bolster as an organization to ensure operational readiness. Taking the time to codify standard operating procedures and formalize a flexible DCT operational model will set sponsors on the right foot to move forward efficiently and effectively while accounting for internal or external barriers.

DCTs are now considered a patient centric model for sponsors that want to enhance the patient and site experience and generate more robust data. As DCT evolves, an embedded approach backed by the right processes and tools will maximize the benefits that DCTs bring to clinical research. Focusing on careful curated components that fit the therapeutic area and meet patient needs will have compounded value across the development continuum and will prepare sponsors for the next wave of innovation in this space.