Decentralised trials – aided by tech – could boost clinical research

Health visitor and a senior woman during home visit. A nurse talking to an elderly woman.

Bringing clinical trials to patients – rather than the reverse – could be the key to improving recruitment into studies and making them faster, cheaper and more likely to succeed, according to one clinical research organisation (CRO).

There’s already plenty of support from regulators for virtual or ‘decentralised’ trials, including from former FDA Commissioner Scott Gottlieb who said last year that the agency was encouraging adoption of this approach to make trials more “agile and efficient”, as well as patient-centric.

Since the coronavirus pandemic interest in decentralised or hybrid trials that can include a combination of in-home clinical visits from healthcare professionals, direct to patient support and digital healthcare has been renewed, says CRO ICON in a new white paper

The trouble is, clinical researchers have been talking about the shift to decentralised trials for years, but haven’t been so effective at putting the idea into practice, it adds.

Some obstacles to take-up have been trial sponsors’ fears of liability if a problem arises during a home visit by a clinical investigator, finding suitable staff to carry out home visits, and jeopardising relationships with clinical site teams.

There’s a pressing need to improve efficiencies, given that the cost of bringing a single drug to market has increased 145% from about $800 million to $2.6 billion in the past 10 years, says ICON.

A big part of that escalation in costs is the cost of running trials, with 86% of all studies failing, and inadequate subject recruitment and high dropout rates cited in 85% of those failures.

Prior surveys suggest that the location of a clinical investigation site is a key consideration for almost two-thirds of trial participants, while four out of five organisations conducting or sponsoring studies said that having reliable transportation is important for subject recruitment and retention.

There’s little doubt that for most patients, participating in studies from the comfort of their own home – either from a visiting investigator or via digital means such as phone or online contact – is preferable to clinic visits.

For instance, the decentralised approach avoids disruption to school, work or other obligations, expands the pool of subjects to include those who have mobility problems, and allows visits or consultations during evenings, weekends or holidays when investigator sites may be closed.

That in turn could increase the success of clinical trials, shorten development timelines and potentially allow new treatments to be brought to market more quickly, says ICON.