What decentralized trial design shifts mean for site feasibility

Placeholder post. This is a short, clearly-marked stand-in for original commentary Dr. Golikova will publish here and cross-post from LinkedIn. It's real content, not filler text, but it should be treated as a placeholder rather than a final piece.

Decentralized and hybrid trial designs — remote visits, local labs, direct-to-patient drug shipment, e-consent — have moved from "novel option" to a default design consideration for a growing share of new protocols. That shift has direct consequences for how feasibility assessment and site activation get done, which is worth naming plainly rather than treating decentralization as a purely operational or purely regulatory topic.

Feasibility questions are changing shape

Traditional feasibility assessment weighs a site's patient population, staff capacity, and historical enrollment performance. A hybrid design adds a second layer: which parts of the protocol can be decentralized for this population, and does that actually expand the eligible patient pool, or just relocate the same administrative burden onto a different team? For oncology specifically, where many procedures genuinely require an infusion center or in-person imaging, the honest answer is often "some parts, not all" — and feasibility assessments that don't distinguish between those parts tend to overpromise.

Site activation timelines absorb the complexity

Adding remote monitoring vendors, local lab agreements, and direct-to-patient logistics to a protocol doesn't remove site-level work — it adds a coordination layer on top of it. In practice, this has meant site activation timelines increasingly depend on how early those vendor relationships and local agreements are locked in, not just on a site's own IRB and contracting speed. Programs that treat decentralization as a late-stage operational add-on tend to see it become the activation bottleneck instead of the intended accelerant.

The patient-matching implication

There's a more direct connection to what ClinicalMatch is built around: decentralized elements change who is realistically eligible for a trial, not just how convenient it is for them. A trial with remote follow-up visits may be genuinely accessible to a patient three hours from the nearest site in a way a fully in-person protocol isn't — but only if that distinction is captured in structured eligibility data, rather than buried in protocol language that a matching tool — or a patient — has no practical way to parse.

That's the piece we think is still underbuilt industry-wide, and it's a large part of why structured eligibility criteria matter as much on the research-operations side as they do on the patient-facing side.