“Decentralized Clinical Trials” is Muddled

Decentralized clinical trials (DCTs) are an ambiguous concept. Some sponsors give patients or sites the option to choose DCT in addition to more conventional clinical trial methodologies. Technology firms that had already based their operations on DCT (i.e., ePRO and EDC companies) before the concept of DCT existed are now repurposed as DCT solutions. Decentralized service businesses have prospered, offering services like remote blood draws at the patient's home.

DCTs are here to stay but are unclear to many, according to an interesting industry discussion I had on the subject with a few clinical trial professionals.

How DTRA defines DCTs

The Decentralized Trials and Research Alliance (DTRA) recently released a definition for DCTs as “a clinical trial utilizing technology, processes, and/or services that create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site.”

Word on the street: The definition is muddled

Qualitative feedback on DCTs indicates the definition is muddled*:

• Study Site: “The environment is still very muddy. Many sponsors refuse to take even the smallest steps toward simple "DCT" solutions. I've attempted to persuade sponsors to adopt site-side solutions, but they're not interested. Eventually, I'm sure, things will begin to stabilize, but right now, everything seems to be in disarray.”
• Study Site: “DCT/Hybrid trials are a fantastic idea, but their execution is subpar because planning ignores trial sites.”
• CRO: “DCT will remain in place. Cultural obstacles and technical flaws, or let's call them what they are, "technology knowledge gaps," would progressively decrease after adopting comprehensive quality control measures for bridging these gaps, as required by GCPs.”
• CRO: “DCTs have not yet delivered on their promise of patient-centered research with less administrative burden.”
• Sponsor: “The concept of DCTs is still relatively new in the clinical research world, and meaningful, lasting change is not something that takes root quickly in our industry. I think it is important to have a consensus or general agreement around the term DCT. Time and clarity around meaning will be the benchmarks for more widespread adoption.”
• Sponsor: “DCT must be more adaptable so that patients may choose the setting they feel most at ease. I am not opposed to DCT, but it must be comprehensive and consider the rising demands of the larger population. DCT must be more adaptable to let people choose the environment where they feel most at ease.”
• Industry Expert: “You shouldn't restrict patients from feasible options in DCT. Choosing where to get blood drawn that particular day gives patients extra freedom. We must consider that extra options also leads to greater programming complexity, so best to find the right balance. More options make a good patient experience, but they must be high-quality options, with supported processes.”

To summarize these comments, DCTs need:

1. Definition: DCTs need to be clearly defined.
2. Options: DCTs must deliver high-quality options to patients and sites.
3. Collaboration: Sponsors must incorporate the site’s perspective when designing DCTs.
4. Adoption and Data: More companies adopting and executing DCTs will yield data, contributing to consistency and clarity.

What about scalability with optionality?

Clinical trial scalability and quality risks are two critical aspects to consider when incorporating optionality. Although clinical trials have a high degree of consistency (especially in relation to ICH/GCP standards), operating studies always vary unexpectedly. While giving patients and sites more options is beneficial and more patient and site-centric, introducing more study risks has a negative impact. For example, the reconciliation of lab data from a mobile blood draw vendor that processes bloodwork within its lab and bloodwork shipped to a central lab from the site necessitates additional training and effort to maintain data quality from two distinct sources (especially if different vendors are used for DCT and traditional clinical trial methods). Another example is reconciling investigational products from two vendors who ship and track them differently (i.e., either to the patient's home or to the site).

Expecting studies to scale with too many options or without consistency (i.e., using two vendors instead of the same vendor to conduct both DCT and traditional methods) not only introduces risks but also increases workload and resource utilization to run the study. The key will be finding a balance between offering robust and consistent traditional and DCT options to allow for clinical operational quality and scalability.

We’ve been here before

I recall the early days of risk-based monitoring (RBM) when the FDA issued its first guidance on the method. Many sponsors defined their version of RBM, and many vendors jumped on board. It took years for the industry to standardize and implement the process across the board and for genuine RBM vendors to stand out.

What’s next?

I expect a lot of debate and different models on the topic of DCT at first. However, the concept will evolve into a more standardized construct across the industry as regulators, non-profit organizations, sponsors, and vendors work together to standardize it. It will be an interesting evolution to watch.

* Comments are anonymized and rephrased to protect user privacy.