Three trends guiding the digital transformation of clinical trials

Moderna announced that it has begun clinical trials of a booster dose of vaccine designed specifically to combat the Omicron variant of the coronavirus – Copyright AFP Stefani Reynolds

How will the drug discovery process progress in 2024? Central to the development of new medicines are clinical trials, as firms seek to demonstrate efficacy to regulators. Considering some potential changes for Digital Journal is Melissa Easy, VP of Clinical Technologies at IQVIA.

Easy focuses on three important shifts in 2024.

AI enhancing humans, not replacing

The first topic is artificial intelligence. Easy weighs up how this technology will affect the design of clinical trials.

Here Easy finds: “As we move into 2024, the integration of AI in clinical operations is set to enhance, not replace, human roles. Contrary to ongoing discussions about AI displacing jobs, the use of AI tools marks a significant shift in the healthcare landscape. New AI tools, like generative AI, are poised to augment human capabilities, alleviating administrative burdens by automating routine tasks and enabling professionals to focus on more strategic aspects of their roles.”

To understand the true potential, clinical trails need to be broken down into constituent stages. Easy draws out: “In the different phases of clinical trials, the advent of generative AI will empower research sites with tools to address anticipated study start-up challenges. This includes increased adherence to regulatory standards across countries, enhanced collaboration among multiple sites and optimized patient recruitment. For sponsors, on the other hand, this could mean being able to sort and select the right sites for the right study, ensuring they are following the correct protocols and, ultimately, successfully rolling out new trials.”

Summarising the benefits, Easy concludes: “The implementation of AI will lead to a more collaborative and efficient trial environment. Instead of taking over jobs, it will allow professionals to dedicate optimal time to patient-facing activities – and add in the context that only humans could provide.”

Technology’s role in driving clinical trials speed and agility

The second area relates to agility, an important digital transformation concept: “The heart of clinical trials lies in the ability to deliver results faster and more accurately. With more studies anticipated to be conducted in hybrid and remote environments, more challenges will arise, specifically distinct ones for patients, sites and sponsors.” 

In terms of what to expect, Easy says: “As we start the new year, effectively recruiting patients and personably connecting with them will be a major undertaking. Sites and sponsors will also see increasing challenges in terms of improving their workflows, orchestrating interactions with patients or effectively gathering study data. AI will play a key role in analysing the increasingly vast volume, velocity and variety of data generated to deliver deeper insights faster and automate actions for faster resolution to potential issues.” 

Responding to this in a measured and coherent manner is essential, notes Easy: “In this context, strategies and solutions that empower all stakeholders will be paramount. In fact, next year will highlight the need for further trial transparency and personalized experiences to optimize outcomes.”

A related concept is connected intelligence, first developed in the transportation sector. By this, Easy means: “We will also see a transition to connected intelligence. Clinical trials will exponentially increase their adoption of AI and other newer technology trends searching for the best formula to enable better protocol design and site selection, patient accrual and enrolment, enhance operations and accuracy across clinical trials and keep studies on track. The ultimate goal for trials is to enhance the quality and efficiency of the study, ensuring the successful delivery of life-saving therapeutics.”

The interoperability year: More technologies in the marketplace drive the critical need for interoperability

The ability of computer systems or software to exchange and make use of information will be the third key trend. Easy observes: “In the rapidly evolving landscape of clinical trials and the myriad of technologies going to market, the imperative for interoperability will become increasingly evident.  We have seen an influx of diverse technologies, which has led to siloed systems and inefficient processes, hindering the seamless collaboration essential for trial success. A glaring example underscores the urgency: a single site navigating a staggering 22 different systems daily. It is natural to see issues piling up – from gathering data from one system to another to simply logging in to all the different systems.”

How might this appear in reality? Easy thinks: “This segmentation compromises efficiency and jeopardizes the utilization of critical site data. As sponsors adopt new tools, they will increasingly seek strategies that enable a harmonized, interoperable ecosystem. 2024 is not only the year of the implementation of new technologies, but the year when the disparate tech stacks start to seamlessly communicate, ensuring streamlined processes, enhanced collaboration and ultimately, the delivery of impactful, patient-centric clinical trials.”