AUTHOR: JOHN HALL, SVP, BUSINESS DEVELOPMENT, EMEA & APAC
John Hall, SVP, EMEA & APAC at CluePoints, discusses the market factors driving Decentralized Clinical Trial growth and the barriers which need to be removed to fully seize the opportunities on offer.
Growth in Adoption of Decentralized Clinical Trials
The decentralized clinical trials (DCTs) revolution is upon us, and it’s a trend that shows no sign of slowing down.
Boosted by the COVID-19 pandemic, virtual or decentralized clinical trials present a far more patient-centric approach to conducting clinical research, building convenience and flexibility into the process, and allowing participants to engage in trials from the comfort of their day-to-day environment.
In a recent Oracle and Informa Pharma Intelligence survey published at the height of the pandemic, 76% of researchers reported that they had implemented decentralized approaches during the COVID-19 pandemic, with 38% indicating that more than half of their studies are now decentralized.[1]
Furthermore, a recent analysis, published in Clinical Trials Arena by GlobalData, highlights the latest rapid adoption of decentralized trial components. In 2020, 673 interventional drug trials mentioned decentralized and virtual components in clinical registry protocols. The uptake of DCTs is expected to gain further momentum in 2022, with some 1,300 interventional trials forecasted to be initiated with a virtual and/or decentralized component, representing a 93% increase from 2020.
Of course, DCTs incorporate a multitude of technologies and services. Common core components include eConsent, ePRO, connected wearables, medical devices, and telemedicine. It also includes home healthcare, local pharmacy services, and new services that supply investigational products to a participant’s home. In the recent analysis performed by GlobalData and published in Clinical Trials Arena, telemedicine has been the most frequently used component of decentralization, with home or alternative sites being the least common.
The Market Factors Driving Growth
So, what is driving this revolution? The COVID-19 pandemic certainly accelerated the adoption of DCTs, and in doing so, demonstrated how virtualization could improve both the patient and physician experience.
At the same time, increasing comfort with digital health technology among consumers and physicians has aided the operational and logistical implementation of the model and enhanced participant expectations of their clinical trial experience.
Ultimately, one of the key reasons for continued growth is an increasing awareness of the model’s many benefits. This includes improved patient recruitment, retention, compliance and diversity, as well as study efficiency and resilience.
For a start, decentralized approaches lower the participant burden and allow for the design of more patient-centric studies. This is critical to overcoming the age-old problems of enrollment and retention, particularly as personalized and rare disease treatments shrink the pool of eligible participants.
By providing access to a more diverse cohort, DCTs can help ensure the safety and efficacy of treatments across the entire patient population. In addition, they utilize engaging and intuitive applications and devices to improve compliance and protocol adherence.
The use of digital technologies can also facilitate more frequent data collection, allowing researchers to capture fluctuations in disease signs and symptoms often missed between traditional periodic site visits. In certain therapeutic areas, such as neurology, this is enabling sponsors to utilize more objective, quantitative, and continuous ways of measuring disease signs and symptoms.
For all these reasons, DCTs can shorten study timelines and increase the likelihood of trial success, thanks to shortened recruitment times, improved patient retention, and enabling more objective measures of patient outcome.
Mobilizing the Expertise
As the pharma and biopharma industry moves to embrace this brave new world, specialist technology providers are busy creating mature, flexible, and robust solutions to meet their needs. These include systems that enable the digital patient engagement and collection of data directly from trial participants through the integration of electronic health records.
CROs also seek to combine home health and other local services (such as pharmacies and imaging) with mobile health, wearable technology, and connected health platforms to provide sponsors with more seamless and complete offerings.
Pharmaceutical companies are also driving the growth in the market, creating in-house DCT expert groups and investing in the technology and processes needed to operate this new model of conducting clinical trials at scale.
At the same time, changes to the regulatory landscape are simplifying adoption and moving the model into the mainstream. For example, during COVID-19 agencies including the FDA and EMA moved quickly to issue new guidance on modalities to enable ongoing trial conduct. This included telemedicine to collect adverse events and ensure continuous medical care and oversight as well as direct-to-participant investigational product supply and home nursing [2], [3].
Furthermore, the FDA has established a Digital Health Center of Excellence[4] and modified its guidelines on software-as-medical-device. This is aiding the advancement of digital health technologies (such as mobile health devices, Software as a Medical Device (SaMD), and wearables) when used either as medical devices, and to also support the investigation of novel medical products. The FDA also set up a Clinical Outcome Assessments (COA) Qualification program[5] , which provides a mechanism whereby novel outcome assessments, deliverable through DCT approaches, can be qualified for use.
Such moves have led to an increasing number of tools and devices for the remote capture of novel data sources and measurement of disease signs and symptoms being validated, creating a robust route to broader use. The recent efforts of the Digital Medicine Society to document the number and type of digital endpoints being used in industry-sponsored studies further demonstrate this increased adoption, where 91 different sponsors have reported using digital endpoints in their trials, and 91 out of 302 digital endpoints recorded were used as primary endpoints[6].
Establishing Common Nomenclature and Best Practice
While practices have primarily been designed in-house and with vendor-specific approaches, industry associations, working groups, and public-private partnerships are now working to develop common definitions. This critical work is enabling further adoption.
The Association of Clinical Research Organizations (ACRO), for instance, created an expert working group to examine adoption barriers and released a DCT Toolkit to help organizations implement DCT approaches[7]. In addition, the Clinical Trial Transformation Initiative (CTTI) has also developed advice to address the logistical, legal, and regulatory concerns related to certain aspects of DCT trial design and conduct[8].
The new Decentralized Trials & Research Alliance (DTRA)[9], is working to establish common standards and KPIs, provide education, share best practices and evidence of value. Similarly, the Digital Medicine Society (DiMe) has developed a library of digital endpoints[10] and a playbook for successfully developing and deploying digital clinical measures and remote monitoring[11].
Removing Remaining Barriers
All this points to substantial movement within the clinical research ecosystem. However, if we can fully seize the opportunities offered by DCT and introduce industry-wide practices, there is still work to be done.
Clinical trials are unfamiliar experiences for patients, and there is huge variation in their comfort with and access to technology. We must, then, improve the training and support of participants and tailor user interfaces to specific patient populations.
There is also significant variation in global regulatory guidance, which leads to additional complexities in trial design and planning when implementing decentralized approaches in multi-country studies. A more unified approach would simplify international study conduct.
There is also limited understanding of the risk to patient safety and data integrity in DCTs and how to mitigate and manage these risks effectively. Therefore, we need to continue to adopt Risk-Based Quality Management (RBQM) and centralized monitoring alongside DCTs to ensure that risks are effectively identified and evaluated and that disparate data sources are brought together under a centralized monitoring approach to provide effective oversight of all data sources and associated processes.
Clinical trial sponsors also need to overcome internal challenges around skepticism by sharing best practices, evidence of value and develop DCT operating models by pooling expertise across in-house functions.
We have already come so far on the road to embracing DCTs. Now is the time to break through those final barriers and make clinical trials more patient-centric and efficient while maintaining patient safety and data integrity.
Get in touch today to find out how we support pharma and biotech partners to implement DCT approaches in their studies, evaluate risk, and remotely monitor through centralized approaches.
