At the outset of the pandemic, the number of clinical trial starts dropped by 50%, and the number of investigator-observed trial activities by 60% (Source: Nature). In search of a solution, the industry turned to an area of clinical trial innovation that had been waiting in the wings for years - decentralised clinical trials.
What are decentralised clinical trials?
The term evolved from innovative thinking around virtual trials, based on a simple idea - what if trial activities weren’t based at a central site? What if instead, patients were at the centre of the model, saving valuable time and money for both patients and investigators.
Trial activities could be conducted virtually using simpler procedures and a mix of tech and telehealth to collect data remotely, away from clinical sites. More advanced collection, tests or procedures could be performed at mobile sites – or occasionally at hospitals if they were truly complex – but all still located around the patient.
By removing the need to travel great distances, this model allows trials to reach far more patients and reduce observed biases in patient selection, as more people feel they can participate in the trial alongside their everyday life. With less of a burden on patients, the quality of observed health outcomes improves, and fewer patients are likely to drop out of the trial. Finally, by putting patients at the centre, the data collected will be increasingly relevant to the real world, and therefore richer in its applications.
How are decentralised clinical trials currently being run?
This analysis by McKinsey surveyed a group of investigators and trial providers about their experience of the DCT uptake and implementation following COVID. The broad consensus is that they do not expect fully virtual trials to find success beyond specific use cases (e.g., a low-risk drug with endpoints that can be easily measured virtually).
Despite that, many respondents in the report have begun to work with decentralised elements in at least one Phase II trial. Examples of these endpoints include online recruitment, direct-to-patient clinical supply, patient concierge services, and electronic outcomes measurement (clinical and patient-reported).
What does this mean for the future of decentralised clinical trials?
There will always be a need for some central site-based trial activities, that’s inescapable. Patients are becoming increasingly comfortable with health technology, however, regulatory environments increasingly favourable, and patient preferences increasingly respected – all of this means that we should anticipate a widescale adoption of decentralised components.
The same McKinsey analysis shows how, for a range of therapy areas, the use of virtual interactions skyrocketed during the pandemic before settling at between 1.5 to 3.3 times their original values - ultimately demonstrating an overall increase in familiarity with virtual interactions that is expected to be permanent.
There are some headwinds to be wary of, particularly ones pertaining to data quality and compatibility within hybrid models. As such, we must expect speedbumps while manufacturers, research providers, and regulators adapt their models to understand and deliver against the expectations of hybrid trial delivery.
Despite these challenges, there’s no denying that the fundamental recipe book for clinical trials design is being rewritten and, in our opinion, for the better.
Big problems need bigger solutions
Accenture recently published an analysis exploring the importance of patients to the clinical trial process. This isn’t an entirely new insight, but they have correctly identified a major failing in many clinical trials to identify and cater to the needs of their patients.
The impact of this is quantifiable, with a gross majority of trials being discontinued due to poor retention and nonadherence. Simply put, trials have not been doing enough to keep their patients healthy and happy, and they have suffered very tangible losses as a result.