Inevitability of Technology Innovation in Clinical Trials
The drug development process is known to be heavily regulated like the finance industry with repercussions for negative impacts on Patient safety and data integrity. These necessary protective measures also introduce significant ‘red tape’ to innovation. What we also know is that technology innovation in other industries, particularly the global rise of social media, use of Apps and venture capitalist investment into start-up companies are collectively causing an inevitable shift in how patient data is accessed, processed, analysed, integrated, shared and archived.
This evolution of consumer behaviour and the resulting globalization of data and information is what I predict will drive the technology innovation cycle faster in the clinical trials environment. The emerging enabling technologies such as Blockchain (featuring the high security of cryptography to create automated smart contracts that are decentralized and immutable) and AI (enabling faster, real time automated analysis of large volumes of data) are most impactful on large volumes of sensitive and confidential data shared across multiple databases, stakeholders and locations. Therefore, it makes the most sense to accelerate development of relevant use cases of patient data sharing that captures health data from the most remote or highly regulated processes in clinical trials to accelerate the adoption of these two technology innovations.
For the next era of clinical trials to emerge faster, use case developments for technology innovations needs to achieve dramatic and measurable positive impacts to motivate the industry to accelerate adoption. How can use cases be developed, let alone accelerated? Well, the magic word is collaboration particularly, if you are not an expert or in a technology start-up company. I testify to this approach working as witnessed through my role as the Co-Lead of the PhUSE Blockchain working group where over 90 cross-industry members including Blockchain providers have delivered a white paper and demo on Patient data sharing without a CDA, contract or dedicated budget (just our time commitments and nerdy personalities).
“Learning and innovation go hand in hand. The arrogance of success is to think that what you did yesterday will be sufficient for tomorrow.” – William Pollard
Imagine propelling these technologies into data acquisitions either directly self-reported or measured from patients, healthcare providers, government agencies or as data transactions between pharmaceutical or biotechnology companies. Examples of impacts on the discovery phase includes provision of sufficient data for meaningful statistical analysis for trial modelling, exploration of biomarkers and pressure testing clinical endpoints using live Patient data feeds across different patient populations, addressing the diversity gaps and lack of heterogeneity of clinical data. For the development phase, the challenges of Patient enrolment and retention can be addressed through secure Blockchain enabled platforms that allow proactive and real time Patient interactions with different clinical trials offerings for self-nominations and matchmaking eligible Patients to trials. Data handling and analysis takes on a different approach entirely with new trial designs that look at longitudinal data from multiple real-time data sources (providing combinations of linked data such as biological, cognitive, functional, imaging, genomic data as needed).
To truly deliver to the Patient needs, it would also appear that current clinical trials processes are incomplete due to inadequate insights, speed and transparency not being anywhere near to what it can be without using these technology innovations. My prediction of how companies will react to these technologies is to form new technology oriented organizational layers that integrates the discovery and development groups to the commercialization arms of the industry to keep generating ongoing Patient insights that seamlessly inform and inject value into discovery and development cycles. If these innovations stagnate or the barriers to change prevail, companies will risk losing out on various competitive advantages, failing to build positive public reputations and ultimately not doing the right thing by Patients.
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“The history of innovation is the story of ideas that seemed dumb at the time.” – Andy Dunn