We often talk about the digital paradigm shift that is currently unfolding in the clinical trial industry and in the healthcare environment at large. This shift is driven by technological breakthroughs over the past two decades and demonstrated by several industry-wide trends, a lot of which have been accelerated by the pandemic. In this article, we’ll zoom in on each of these trends and explain how these will affect the industry’s current way of working moving forward.
From Centralised to Decentralised
The clinical trial industry is gradually moving towards a more decentralised operating model. While traditional, centralised clinical trials weigh heavy on patients travelling to research ‘sites’ (such as a hospital), decentralised trials leverage digital technologies to enable patients to participate from their own homes. In practice, this means that instead of collecting all research data on-site, data is now collected remotely. This goes hand-in-hand with the adoption of remote monitoring solutions, through which so-called Clinical Research Associates (CRAs) monitor the validity of clinical trial data and execution without being physically present on-site.
From Siloed to Open
Virtually all clinical research professionals experience issues related to interoperability constraints. These issues result out of the current clinical trial software (‘eClinical’) solutions landscape, which comprises many isolated function-specific eClinical solutions or eClinical platforms that adhere to a closed operating model. Not surprisingly, there’s an industry-wide need for a more open and interoperable approach to software. This need can now be addressed by coopetition between software vendors and by the rise of emerging (Web3) technology standards for cross-platform interoperability.
From Reactive to Proactive
For many decades the industry has adhered to a reactive way of working, characterised by extensive on-site monitoring and source data verification (comparing source data with data recorded in the electronic data capture system). These activities consume significant amounts of time and resources and are certainly not always effective, as the possibility for human error remains. As the industry advances its processes and technology, stakeholders are now making the switch towards a proactive way of working, fuelled by real-time reporting and integrated analytics and characterised by a more risk-based approach to trial management and oversight. This is relevant to the entire value chain, as we apply Quality-by-Design and Privacy-by-Design principles in the development of our software infrastructure and quality management systems.
From Trust-based to Trustless
In an increasingly digital, complex, and globalised world we can certainly not forget the element of trust. Relationships with partners and preferred vendors are currently trust-based, where trust is placed in the reputation and capabilities of these vendors. Blockchain-based technologies now provide us with a unique opportunity as they allow for trustless collaboration which is proof-based and where the interpersonal trust component is embedded into the systems that we use. This will hopefully also minimise the need for lengthy vendor audits.
From Manual to Automated
Lastly, automation is playing an increasingly dominant role in clinical trial execution. This replaces manual SOP-driven workflows, rules, checks, and balances that the industry has adhered to for many years. The possibilities for automation are widespread and driven by workflow tools in eClinical software and Artificial Intelligence (AI).
From Generic to Personalised
The technology and process-driven trends described above ultimately allow the industry to move from a generic one-size-fits-all approach towards a more personalised patient-centric approach to clinical research. We now have the technology available that allows us to collect data in real-world environments (so-called ‘Real-world Evidence’) and we can use the same technologies to realise a better patient experience as we inform, engage, and empower patients throughout the entire clinical trial value chain.
While the added value of these trends is evident, the digital paradigm shift does brings new technical, privacy, and regulatory challenges. At Triall, we strongly believe that blockchain and related Web3 standards will play a dominant role in overcoming these challenges and enabling this new operation model, thereby allowing for a future of smarter, safer, and more-efficient clinical trials.