Decentralized Clinical Trials: What Biotechs Need to Know

The buzz around decentralized clinical trials, or DCT, has captured the attention of organizations across the clinical research industry, prompting no small degree of excitement, apprehension, and speculation.

DCT has some in the industry cheering, some biting their nails, and others scratching their heads. But what exactly does DCT mean—and will it truly change clinical research? 

To help biotech professionals get to the bottom of this, we’ve compiled insights into the benefits, risks, and common misconceptions surrounding decentralized clinical trials.

What Are Decentralized Clinical Trials?

A decentralized clinical trial is any trial with a remote component. Typically, participants complete site visits from a participant’s home or remote location. To facilitate remote participation, researchers and participants often partner with home health nurses and local labs. They can also leverage technology like eConsent and ePRO.

The remote components of clinical trials raise questions around data management, which any biotech will have to consider before pursuing DCT. For instance: How will dispersed sites share content and collaborate in a secure, compliant fashion? Stay tuned, as we’ll be diving deeper into this in an upcoming post.

What Are the Benefits of Decentralized Clinical Trials?

Research across industries and business functions has shown that minimizing operational barriers leads to higher engagement. DCT provides patients with flexibility to break through obstacles impacting trial timelines and data quality.

More Control for Patients

Many trial participants find it impractical to attend traditional, physical site visits. They may live far from the facility, or have busy work schedules and would prefer to receive care remotely. Other patients may value the personal touch that they feel only comes from in-clinic visits.

DCT offers participants a choice between these two modes, so they can participate on their own terms. With the clinical research industry placing an ever-higher premium on patient centricity, the flexibility offered by DCT is invaluable.

Greater Patient Diversity

Insufficient diversity in patient pools is one of the most persistent, vexing challenges in clinical research. But by enabling remote participation, DCT expands access to a broader patient population, encompassing a wider variety of genetic and biological profiles. Moreover, DCT has positive equity implications as well, since people of color often face greater hurdles in taking a half day at work and driving long distances to trial sites.

Stronger Patient Retention

The more convenient it is for someone to participate in a trial, the less likely that person will be to drop out before the trial is complete. Even replacing one in-clinic visit per month with a remote alternative can relieve a lot of the burden of participation, which will improve the quality of the collected data.

What Challenges Are Involved?

As promising as decentralized clinical trials are, there are a few things the industry will need to reckon with before they can scale across therapeutic indications and global regions.

Being Smart With Technology

Technology like eConsent and ePRO can go a long way toward facilitating remote data capture and study participation. But like all technological advancements, they can also complicate things if not used properly. It’s not enough to quickly slap together a tech stack and hand it off to users. Organizations need to sufficiently train stakeholders in relevant processes as well as technology solutions. They also need to ensure those solutions are well-integrated into the workflow of the trial, with appropriate data security and governance controls in place.

Messaging

DCT is still new enough that researchers, patient populations, and other ancillary stakeholders haven’t yet aligned around a common definition. The term means different things to different people. Until that changes, discussions of DCT can create confusion that, in turn, creates barriers to adoption.

Regulation

One of the core promises of DCT is that it facilitates recruitment and trial conduct across wider geographies. But without a centralized regulatory framework around DCT, this can create new headaches. For instance, different U.S. states have different laws governing the use of telemedicine—to say nothing of regulatory differences between the U.S., EU, and APAC. DCT may enable researchers to recruit participants from four different countries, but that also may force them to reckon with four different regulatory bodies.

Common Misconceptions about Decentralized Clinical Trials

As with any emerging technology, many people have an imperfect understanding of DCT. Here are some clarifications that may temper both overblown fears and overeager celebration. 

Misconception: Traditional Sites Will Not Have a Role

Trial sites are the frontlines of clinical research and are fundamental to any study. It’s understandable that some in the industry feel nervous at the prospect of replacing them with nascent virtual processes.

Reality: Traditional Sites Are Not Going Away

The reality is that DCT does not mean the end of clinical trial sites—it simply preserves them as one of a suite of options available to trial participants. As discussed earlier, some participants may prefer remote site visits while others would rather go in-clinic. DCT is all about providing them the flexibility to choose. 

Misconception: DCT Is Equally Applicable to All Sites

It’s easy to assume that the trend toward DCT will have roughly the same impact on all sites. Should all sites expect the same challenges and benefits, and prepare for them in the same ways?

Reality: DCT Is Easier for Some Sites Than Others

Not all sites will be equally equipped to transition to decentralized processes. Some bring their own digital tools and work with sponsors to incorporate them into remote workflows. Others don’t yet have the infrastructure to support the use of these tools, which could make adopting DCT models more intensive and time-consuming.

Learn More

There’s a lot more to decentralized clinical trials than we’ve covered here. In a fascinating discussion during Egnyte’s Life Sciences Summit earlier this summer, we explored the subject further with two clinical research professionals who have direct experience in DCT:

• Hassan Kadhim, Senior Director, Bristol-Myers Squibb
• Scott Pearson, Chief Product Officer, THREAD Research

Follow the link below to watch the full discussion on demand for more insights into this exciting new approach to clinical research.

‍