Best Practices For Implementing Decentralized Clinical Trials

By Sam Brown, Nell Haslett-Brousse, Ryan Quinn, and John Theodore, Point B

Today’s new COVID realities mean changes in how clinical trials are administered. Here’s what to consider in adopting decentralized clinical trials.

As the COVID-19 pandemic turned the world upside down, clinical trials have been deeply impacted, with thousands of trials either canceled or delayed — all during a time in which speed-to-market is critical in helping deliver a vaccine to the global population.

To continue trials with as little disruption as possible, the industry is accelerating adoption of decentralized clinical trials (DCTs). While speed-to-market was already the primary challenge for pharmaceutical companies developing therapies, industry stakeholders were also exploring the idea of DCTs to improve the R&D life cycle, and the pandemic acted as a tipping point to move full steam ahead with this initiative.  The interruption of so many traditional trials heightened the importance of DCTs in the life sciences industry, with disease advocacy groups, regulators, providers, and patients actively looking for ways to restart existing trials or design future trials that could be managed remotely. DCTs hold great promise to operate more efficiently, increase enrollment, shorten trial duration, get products to market quicker, and reduce patient burden by limiting travel, streamlining communications, and facilitating digital data collection.

DCTs are not a new concept, but the ability to manage them more effectively with technology is a more recent phenomenon. DCT software platforms enable sponsors to conduct trials with a cohesive set of digital tools and services, reduce patient and site burden, and lessen geographical barriers, all while still providing sponsors with quality data. DCTs are part of a flexible continuum where it is possible to start with a minimum investment (e.g., eConsent only) and build to a full-fledged virtual trial where all components of a DCT technology platform are utilized (e.g., eConsent, ePRO/eCOA, telehealth, and wearables) to gain maximum efficiencies.  The new trial design creates an innovative solution to fit the study population and, ultimately, produce effective outcomes.

However, while the experience design related to the patient is paramount to the adoption of DCT technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms. For example, the site staff often needs to balance multiple technologies across studies, which can lead to a negative experience and subsequently can carry over to negatively impact the patient experience or recruitment for studies. Likewise, from a CRO and sponsor study team perspective, performance measurements and incentives must be considered or there will be a natural disincentive to adopt and leverage DCT technology for future studies.

As you consider implementing DCTs as part of your clinical trials, the following are some key considerations and recommendations.

Consider The Human Side

Be sure to first focus on the human aspect of clinical trials: the patient journey, the challenges of doctors and sites, and the sponsor stakeholders trying to implement change. The users at the center of change will guide the organization’s change management efforts and ensure the appropriate messaging and supports are received.

The Patient

Technology should enhance the patient’s journey, not complicate it. While it is true that DCTs should provide the ultimate patient benefit of making clinical trials more accessible, taking the time to understand patients’ needs and pain points is paramount to driving adoption. At a minimum, sponsors should:

• Map the patient journey over the course of the study life cycle, and at every intersection between the patient and a digital technology consider the full breadth of the user experience in order to design interactions that focus on the patient.
• Conduct patient surveys, engage patient advisory groups, and pressure test protocols from the patient’s point of view to identify which populations will benefit the most from reduced travel, travel costs, time outside the home, or caregiver interaction.  
• Conduct rigorous user acceptance testing (UAT), particularly with remote eConsent, which is often the patient’s first interaction with such technology, to ensure navigation is seamless and intuitive.
• If wearables are part of the study design, consider the size, weight, and aesthetics of the device in relation to the participant.
• Invest in developing or purchasing training documentation and usage guides that patients can access without having to call user support.

The Site

Technology should also expand the investigator site’s ability to engage and treat patients, which requires understanding what sites are willing and able to support.  

During study design, minimize the number of systems utilized to enter and validate data. CRAs that have a streamlined process for entering and/or validating data are prone to make fewer mistakes and to act on rather than delay the more administrative tasks related to data entry.

Conduct rigorous feasibility studies at the site to assess its readiness, especially for trials where telehealth is being considered. Site staff must be comfortable with conducting virtual visits through a screen and without physical touch, and they must be patient enough to train participants on the process so they can endure and overcome any technological challenges they may face.

The Sponsor

Finally, technology should provide study teams new pathways to conduct their protocols. Design trial protocols as “virtual-first” with the patient at the center by approaching the study startup phase with a DCT mindset and a willingness to challenge traditional assumptions. Consider:

• Creating digital simulations or environments, which can help bring to life the flow and benefits of DCTs, pressure test assumptions, and document information for continuous improvement.
• Providing “plug and play” tools and language that study teams can leverage when designing studies and writing protocols.
• Surveying study teams to understand which data are hard to obtain, what populations they are challenged to reach, and what their boldest ideas could be.
• Collaborating closely with platform suppliers to design a protocol that works seamlessly with the platform, reduces operational friction, and eases patient burden.

Incentivize The Adoption Of Digital Technologies In Clinical Trials

Operational data are needed to measure the benefits so metrics can be created and measured over time. Without concrete evidence supporting the time and cost benefits, study teams may view the shift to DCTs as more of a burden than a benefit. Compounding this initial hesitation, if a critical mass of study teams does not make the change and use the technologies, then the sponsor will be unable to achieve economies of scale or even measure benefits to prove that cost, time, and compliance competencies are indeed gained. A stakeholder analysis may be helpful at this stage to help organizations think through what will make each group at the organization want to adopt DCTs.

Removing Disincentives

Perhaps most importantly, sponsors can incentivize teams to adopt DCTs simply by removing barriers that disincentivize, namely, cost. The adoption and implementation structures should allow for some initial friction, growing pains, or “investment” that doesn’t count against study teams’ budgets. Instead of expecting study teams to absorb the risk and demonstrate the return on investment (ROI) immediately, consider funding the use of novel technologies in studies from outside the typical study budget.

Financial And Non-financial Incentives

Further, sponsors should not only consider if additional financial opportunities can offset the costs associated with the new technology but also give teams an outright budget incentive to adopt the DCT model. This could include covering additional costs for other parts of the study budget, assigning extra internal resources, or negotiating more favorable contracts through preferred provider agreements.

Non-financial incentives could include company-wide recognition, promotion criteria, or leadership opportunities in this new space. Moreover, because the regulatory, clinical, and operational requirements associated with widespread adoption are new territory for the industry, the usual experts will not have all the answers. This is an opportunity to help staff develop this expertise, either by hiring specialized resources or by providing the time and money needed to develop resources internally. Conversely, staffing plans that do not include additional resources and instead rely on existing staff to create and implement a new operating model will place a heavy burden on anyone involved and will likely lack the focus needed to be successful.

More Than Just Technology

Ten years from now, if the sponsors of clinical trials have been successful in shifting the industry’s status quo operating model, enough supporting data to prove the benefits of DCTs will exist. However, the only way to ensure these data are meaningful and DCTs achieve the promised outcomes is to put the human, not the technologies, at the center of decentralized trials.

Understanding and aligning human needs with benefits and incentives, removing barriers, and executing within the framework of a thoughtful operating model to deploy these technologies will determine whether mass adoption is achieved. If technology is the door opening to a better clinical trial, experience and patient- and site-centric trial designs are the keys.

About The Authors:

Sam Brown, Nell Haslett-Brousse, Ryan Quinn, and John Theodore are consultants with Point B, a consulting company that helps organizations in the areas of customer engagement, growth investments, workforce experience and operations excellence.