Decentralized Clinical Trials: Are They Here to Stay?

The adoption of technology in clinical research is a traditionally slow endeavor. However, in 2020, a year riddled with unparalleled challenges, the industry adapted and responded in rapid fashion. Measures were taken to allow for continuity of studies, all while shortening timelines and ensuring safety and flexibility of care. This flexibility can be seen through trial decentralization– enabling care to be continued through varying methods, whether bringing care to the patient’s home, allowing patients to benefit from local labs or utilizing technology to complete trial requirements.

This response by the industry was impressive and perhaps provides a glimpse into the future of clinical research. But what does the future look like? While we cannot be certain, I will leave you with some of my thoughts.

• What are the benefits of Decentralized Clinical Trials (DCTs)?

Traveling for a clinical trial visit – whether across town or across the globe, presents numerous concerns and hurdles for study participants. COVID-19 and the possible transmission of the virus has only amplified these apprehensions, increasing the likelihood of study drop out.

However, bringing the study to the participant – a core tenet of decentralized trial activity, limits the time, travel, exposure and expense associated with a visit – opening doors for those who may not have had access to research in the past; this includes supporting the mission of engaging diverse or underrepresented populations in research, an area that I am excited and passionate about.

From a sponsor’s perspective, decentralized clinical trial technology has helped keep studies running in 2020, giving them the data needed to demonstrate success and showing sites that they are willing to do what it takes to complete a trial while ensuring safety, effectiveness, and patient convenience.

• Can the momentum be maintained post-COVID-19?

I absolutely believe the momentum towards adopting technology to facilitate clinical trial flexibility will dramatically broaden. Clinical research has been trending in this direction for years and 2020 was the tipping point.

The global pandemic helped spur the adoption of tools that deliver added participant convenience. In the end, these tools will yield more data and further insight into the patient experience and site adoption that will only continue to drive innovation.

The proportion of in-person vs. virtual visits may fluctuate based on the pandemic or other dynamics, but I believe the rise of decentralized clinical trial technology will evolve and persist as technological advancements continue to press forward.

• What are some of the remaining barriers to adopting a hybrid or DCT approach?

As with anything trending, all eyes will be on the results. We expect sites, sponsors and CROs to analyze data from 2020 to understand whether using decentralized technology kept clinical trials operational in the face of COVID-19. Did patients remain enrolled? Did sites leverage the tools made available to them?

After all, sites remain a critical piece of the clinical trial puzzle. Ensuring that sites understand the value of solutions will be key to adoption of hybrid clinical trial technology. In addition, when leveraging new technology, it is essential that in depth training, how-to guides, and an ongoing support structure is included in the offering for the best possible results. Change does not come overnight and for regions that have been less inclined to adopt technology, further investment of time, training and regulatory materials may be necessary.

• How can a DCT model help promote clinical trials as a care option?

In the more than 30 years of living with Type 1 Diabetes, rarely have my Endocrinologists discussed participating in a clinical trial – and I would love to play a part in one.

I’m sure that my doctor has heard of studies, but the potential costs and administrative work of conducting a clinical trial is often a deterrent. These busy practices don’t have working capital to invest in technology, managing the paperwork, engaging in trainings and more.

Simplifying the technology interface and guaranteeing swift reimbursement of expenses can attract more practices to partake in clinical studies and provide choice of treatments to patients – whether traditional or investigational.

Ultimately, clinical research continues to evolve. A key component of this evolution is identifying ways to improve the experience for participants and sites alike – finding ways to provide better, more convenient forms of care. While the rapid adoption of decentralized trials and supporting technology was necessitated by the pandemic, I think the ensuing innovations and advancements will continue to shape the future of clinical trials.