Second Opinion: Decentralised Trials, A Solution In Waiting

2021-11-02 |  Shrinivas Anikhindi

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In this month’s Second Opinion, we explore some exciting news that has come out of the United States, the effects of chronic conditions such as Long COVID on our healthcare systems, and the implications for the future of the industry.

It's time for clinical trials to come home

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.

Accenture correctly identify the problem, but they stop short of the solution by focussing only on the patient experience. Good patient experience management is incredibly important to achieving success in trials, but in 2021 the gap to close is not just about understanding patient needs, but rather how we deliver against them.

Side note: In 2019, we published an in-depth guide to Patient Experience Management which is well worth a read if you want an in-depth view of the fundamentals.

Virtual trials, decentralised trials, clinical simulations - the advent of these models offer a wide space for clinical trial providers to innovate their offerings to fit their patients’ needs. Providers have long known the flaws in the model but have been forced to make hard choices around prioritising clinical and regulatory excellence over patient satisfaction – but not anymore. Now we have the ability to deliver against these identified needs, and that’s what we should be talking about in the coming months.

What else we've been reading

The Blue Pages: Who’s who in the decentralised trials space?

Talking about the rise of investment in decentralised trials inevitably leads to questions of capability. How do you move from traditional trial approaches to conquering this new decentralised frontier?

Anticipating that exact question, Clinical Trials Arena recently published an analysis breaking down who the key players in the field are. The full piece is well worth a read, but we’ve just called out some of the most exciting names here, including a couple which aren’t featured in the article.

  • Cloudbyz – A CRM-based solution: Fine, so CRM isn’t what comes to mind when you think exciting. But the potential of this system is huge, built natively onto the back of Salesforce and covering all the bases, from pre-screening of patients to study budget management.
  • Medidata – A broad-spectrum DCT provider: This clinical trial technology firm offers an end-to-end solution for implementation of decentralised trials. Their proposition focuses on the offer of a wide range of services, from registry support to post-trial engagement of patients.
  • Lightship – Flexible and inclusive for patients: A recent start-up, the virtual clinical trial platform Lightship has found success with running decentralised trials at scale through a combined approach of operational excellence and patient inclusivity.
  • Medical Research Network (MRN) – Mainstream implementation of decentralized care: Previously offering a range of trial support services, MRN rapidly upskilled to a decentralised model during the pandemic, and now complete over 1500 home trial visits per month.

The PEN Perspective: 

These partners, and the others in the linked article, all offer a range of cutting-edge solutions for DCT implementation. Remember, however, that no provider is truly end-to-end. Our opinion is that you absolutely must have your strategy for trial delivery and patient experience defined first, before you engage trial providers.

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