How Vault Powers DCTs That Promote Efficiency and Diversity

By Alexander W. Pastuszak, MD, PhD, Chief Clinical Officer, and Hady Khoury, President and Chief Research Officer at Vault Health

Article at a Glance

  • Clinical trials have played a pivotal role in pushing medicine and healthcare forward. However, the standard approach to these trials may not be as effective for larger trials or ones in which a subset of patients need very specific, targeted treatments. 

  • Innovation in the structure and design of clinical trials can help make them more efficient, relevant, and even diverse. These things are necessary for improving patient and physician experience while also creating opportunities for more meaningful outcomes.

  • Vault’s decentralized approach is intentionally designed to make it easier for patients to participate in clinical trials that are studying the effectiveness of new treatments. Our structure and flexibility help us excel in speed, agility, and retention -- all of which contribute to more complete data in clinical research.

Clinical trials are one of -- if not the -- best tools for identifying effective treatments for patients with various illnesses, diseases, or chronic conditions. But like with most tools, there really is no “one-size-fits-all” solution, especially when it comes to participation and retention in decentralized trials (DCTs). To continue moving clinical research forward, it’s important to ask these questions: How do we recruit more people to participate? How do we improve the patient journey? How do we ramp up meaningful insights and save lives? How do we evaluate promising therapies versus ending trials with poor results in the shortest amount of time possible? A well-designed clinical trial and innovation can help accomplish these goals while also promoting efficiency, diversity, and better health outcomes.

Vault’s Clinical Practice Set Runway for More DCT Capabilities

Vault’s entry into the DCT space was seamless because we had already established a medical practice with virtual and in-person capabilities. As a telehealth business, we were primed to deliver fast and flexible care to patients with the help of our comprehensive end-to-end digital platform. This ever-evolving technology helps reduce barriers to quality healthcare by extending the range and capabilities of our 1,200+ licensed practitioners across the U.S. In the event that a medical consult requires an in-person visit or sample collection, our providers are able to meet patients where they are.  This ability to meet with patients virtually or on-site, on the patient’s terms, gives Vault an edge in delivering the best patient experience possible.

Vault’s Approach Boosts DTC Efficiency Through Speed, Agility, and Retention

The standard approach for identifying and developing treatments is to carry out multiple clinical trials in phases. They build on one another slowly over time and with incremental improvements to illustrate what does or doesn’t work in medicine and health care. This traditional paradigm has served humanity well, especially as it relates to developing chemotherapy treatments for different types of cancer, but it is not conducive for clinical trials where targeted therapies may only work in a small subset of patients. It’s time to rethink what well-designed clinical trials look like and how to execute on them effectively.

At Vault, our decentralized approach allows us to excel in three key areas:

  1. SPEED: Our established network and data distribution capabilities allows us to align eligible patients with potential treatments quickly. This helps reduce implementation and recruitment time, which is extremely valuable for our pharmaceutical and biotechnology partners that might otherwise take a year or more to enroll enough participants for a trial.

  2. AGILITY: We have the resources to scale health solutions broadly and quickly. This allows us to adapt to patient and physician needs, and to support our research partners in creating well-designed clinical trials. 

  3. RETENTION: We focus intently on the patient journey. That means doing what we can to ensure that participants do not withdraw from the study, miss study visits, or miss questionnaires. We conduct convenient study visits in patients’ homes, which makes it easier for them to stick with the trial without any logistical barriers.  We also provide electronic questionnaires to track data in real time and follow up with participants who may have forgotten to provide information previously.  All of these tactics yield more complete data in clinical research.

How Vault is Working to Enhance Diversity Through DTCs

It’s no secret that requiring clinical trial participants to travel to and from physical clinics makes it difficult for them to stick with the trial, especially if it’s long-running. More importantly, it narrows the field of participant recruitment—those unable to commit to in-person participation due to mobility, age, or socioeconomic status are eliminated from participating. This has an important impact on racial diversity of participants too: a five-year summary and analysis of clinical trial participation and demographics found that 76% of site-based clinical trial participants are white (caucasian). But we’re making moves to change that. 

Here’s how:

  • Our telehealth platform allows participants to meet with clinical staff virtually for scheduled visits or supervision while measuring vital signs or obtaining specimens. And when an in-person visit is necessary, our staff can visit clinical trial participants at home.

  • Vault’s network, digital platform, and data distribution provide clinical research stakeholders with greater participant recruitment, more diversity, and better retention in DCTs.

  • Our technology stack offers efficient integrations, ensuring that every participant touchpoint is seamless, that all participants who want to take part have access regardless of their socioeconomic status, age, location, or ability, and that the range and breadth of capabilities of the clinical trial staff and investigators are fully supported.

As a people-first business, we understand the importance of positioning our technology to help improve access to care and research that could help save peoples lives. We believe in increasing access to high-quality, personalized care and our entrance into the clinical trial space is a continuation of that core mission. The primary benefit of virtualization and decentralization is enabling a more diverse and subject-centered approach to the trial at hand. But bringing diversity into clinical trials isn’t just an ethical win, it also helps researchers assess and address differences between individuals when developing novel therapies. 

Conclusion

When trials are designed well, we can learn important next steps and yield meaningful results. We’re proud to help organizations run flexible, fast, and efficient trials that engage a more diverse participant population. To learn more about Vault’s efforts to power more efficient  and diverse clinical trials, click here.

References

U.S. Food & Drug Administration. (2015-2019). Drug Trials Snapshots Summary Report: Five-Year Summary and Analysis of Clinical Trial Participation and Demographics. https://www.fda.gov/media/143592/download

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