70% of respondents have been involved in or worked on trials that have implemented some decentralized element in the last two years.
58% say decentralized trials are faster than traditional trials in their experience, saving respondents on average just under 3 months to completion.
71% say decentralized trials are better for patient recruitment than traditional trials, and 74% for retention.
81% say decentralized trials cost about the same or have a lower overall cost than traditional trials.
Decentralized clinical trials have had the potential to revolutionize studies for a number of years, though in the last two years, accelerated by COVID-19, they have finally started to realise some of that potential.
However, to what extent have decentralized trials – and associated elements of Home Trial Support (home trial HcP/nurse visits and VCT/remote technology) – been adopted in the industry? And what are the true impacts on speed, patient recruitment and retention, cost and patient-centricity?
Clinical Trials Europe in partnership with MRN, conducted a huge survey of clinical trials professionals around the world to answer these questions. This final report based on 125 responses reveals unique insights into the adoption of decentralized trials today.
In this section MRN CEO Grahm Wylie introduces the report and we look at the demographics of the respondents. Use the Contents menu in the top left to jump to another section or download this report as a PDF.
What are the therapeutic areas of focus for which your company is conducting clinical trials?
MRN CEO Grahm Wylie introduces the report:
“The implementation of remote decentralized trials has grown exponentially in the last couple of years. However, broadly accepted definitions of decentralized clinical trials (DCT) are lacking, but at MRN we define our role supporting decentralized trials as “services and capabilities that design and support trials to run in the patient’s own community”. Decentralized clinical trials are very topical right now, having had a huge boost through the COVID-19 pandemic. However, don’t mistake them for a pandemic flash in the pan – implementation of decentralized trials has been
accentuated by the pandemic, but history suggests this was a change about to happen to the industry anyway, and is now inescapable. This drive has brought a lot of people closer to the services for the first time with a myriad of questions to answer, some of which are addressed in this report.
The data you see here directly addresses some specific questions you may have – and dispels some myths very clearly. First of all, it is clear that trials run using these services, run faster. Second, they are probably less expensive than their traditional model stablemates, and third, it is clear the patients like the services first and foremost
because it is convenient – for patients in trials, like any consumer, convenience is king.
The market at present is defined by the fact that demand for DCT hugely outstrips supply. The industry has a small number of long term expert organisations – with only 5 global organisations with experience stretching back over more than 10 years in existence. The global CROs have either (in one case only) built their own systems or bought these mid-sized independent providers, setting the scene for integration of these services into their broad landscape of services. This will be a challenge, not one for which CROs have a great track record.
In addition, a series of new entrants are coming onto the field to meet the demand – national companies trying to make the leap to global capability or companies in parallel areas such as lab services or IMP management that want to try their luck in an area of hot demand. At the same time the investment in technology companies continues apace, as we see investors create a financial bubble for technology-based life science companies which will create challenges of sustainability for those companies. Meanwhile the independents are growing at full tilt to fill the void, with all the challenges that entails.
The services we are talking about are a mix of digital tech and medical care. Technology ranges from ‘old tech’ like ePRO and eConsent through to the much newer telemedicine and connected devices. Medical care ranges from nursing to physicians, phlebotomists and lab technicians - which are the most appropriate to use will depend on your trial and for customers, navigating these waters is complex. Questions aimed at assessing services will need to be more sophisticated, leaving behind the basic questions of can a service be provided, is it safe and GCP compliant (after 15 years, we can be sure the answer is “yes”), and moving to deeper examination of service providers in experience and areas of specialisation.
As always, whatever demand is being created, the fundamentals of the sector do not change. IMP safety is still unknown early in a trial
program, so must be treated accordingly. For most medical conditions, a physician also has to be in person with a patient, not just look at them over a video screen and look at their data to know how well or unwell they are. Patients still want “care” – they are not just subjects in an experiment, they are also patients with an illness. Trial designs and service providers have to embrace those realities, not ignore them. How companies differentiate will be on the basis of elements of how these services work and how well they integrate these realities with the needs of the trial.
Companies in this sector will therefore differentiate not in terms of therapeutic area, but in terms of ‘degree of touch’. Some (like MRN) will specialise in “high touch” – services aimed at hybrid trial designs with high levels of face to face support in the community to deliver parenteral drugs, make complex efficacy and safety assessments, examine patients etc. Coupled with that will be full use of digital technologies to capture other simpler data direct from the patient, without the need for either a nurse or the PI in the process. Some companies will specialise in “low touch” – trials with oral medications, already well understood safety profiles (phase IV) and a low need for medical examination of subject. Differentiation will be on quality, scale, regulatory knowledge, specific experience."
In the next section we delve into the data from the survey results.
For the purpose of this survey and report, DCT includes remote clinical trial services. DCT services are used to substitute or complement traditional in-clinic patient visits. This focuses on Phase I, II and III and includes home trial HcP/nurse visits and patient visits supported by remote technology.
