Move Over, Internet: Why AI and Blockchain Are the New Bosses of Drug Trials (And How to Keep Your Job)

Clinical trials—the complex, lengthy process of testing new medicines—are facing a fundamental transformation, driven less by new drugs themselves and more by powerful, foundational technology. According to industry experts, the framework of future clinical trials will rely on artificial intelligence (AI) and blockchain technology to an extent previously unseen, making them as fundamental and indispensable to the sector as the internet is today.

This profound shift from supplementing existing processes to actually redefining the entire industry was the major topic of discussion among panellists at the 2025 Clinical Trial Supply West Coast (CTSWC25) conference, held on September 9th in Burlingame, California. Experts at the conference agreed that this dramatic change is necessary as the sector adapts to two rising demands from participants: greater patient centricity and more robust sustainability in trial design.

The Indispensable Elephant in the Room: AI Takes Center Stage

Artificial intelligence is not just expected to help out with a few tasks in clinical trials; it is poised to become utterly indispensable. Prasun Mishra, the founding director of Agility Pharmaceuticals, claimed that AI will be as vital to clinical trials as the internet. This viewpoint highlights the transformative potential of the technology, which is anticipated to set the foundation for all future trial strategies.

For those working within the industry, the rise of AI presents both opportunity and necessity. Tom Gottschalk, the vice president of business development at Valeris, emphasized the weight of this technological shift, describing AI as “the elephant in the room”. Gottschalk didn't just note its importance; he implored conference attendees to educate themselves thoroughly on how to effectively employ AI in their daily operations. This push for technological literacy is critical, as Gottschalk linked mastery of AI directly to ensuring long-term employment security within the sector.

While the push for this kind of "digital transformation" in clinical trials has been a recurring conversation for decades, according to Luiz Barberini, the head of Latin America external manufacturing at Bayer, the current discussions around AI seem to hold far more promise than previous talks regarding blockchain did years ago.

Beyond the Hype: The Enduring Importance of Blockchain

Even as the buzz around AI dominates the conversation, blockchain technology has maintained its status as a vital component of the clinical trial sector. Blockchain, often described in laymen’s terms as a secure, digital ledger that cannot be altered, is instrumental for maintaining precision and reliability in data.

Specifically, blockchain has become crucial for tracking and safeguarding supply data within the complex logistics of drug trials. Furthermore, this technology facilitates enhanced transparency for the trial participants themselves. By using blockchain, data is made transparently accessible to patients, while the vulnerability of that data to potential hacking is minimized.

The Changing Face of the Patient: Centricity and Data Ownership

The technological advancements embodied by AI and blockchain are occurring concurrently with a growing interest in patient centricity—a focus on placing the patient's needs and experience at the center of trial design.

Panellists at the CTSWC25 conference highlighted that patients today are increasingly informed about the processes and implications of clinical trials. This greater awareness has led to new demands and expectations. Mishra noted that some informed patients are even expressing a desire for opportunities to monetize their own personal data generated during the trials.

Additionally, the demographic composition of trial participants, and their unique values, are shifting the sector's foundational approach. Gottschalk declared simply that “the patient is changing”. Younger generations, for example, are placing greater importance on environmental matters, which translates into a demand for increased sustainability in the design and execution of clinical trials.

This shift requires a proactive response from the industry. Gottschalk suggested that foundational changes in the overall mindset of the trials sector are imminent. Companies that adopt new practices and technologies early, specifically those that address the unique ways younger generations interact with trials, are likely to yield significant benefits in the future.

The Green Challenge: Sustainability and Operational Overhaul

The push for sustainability, driven partly by the environmental concerns of younger generations, presents a serious mandate for the clinical trials industry. Meeting these sustainability targets will eventually become the new standard for the sector.

However, implementing comprehensive sustainability programs poses a significant challenge, particularly for smaller developers, such as biotechs, which often operate with limited resources. Regardless of size, both large and small companies will be held accountable for their sustainability efforts moving forward.

To meet these demanding targets, Gottschalk argued that companies must seek out more efficient methods for running trials.

For older, long-established organizations, however, transforming decades of accumulated operational practices is especially difficult. Luiz Barberini noted this challenge specifically regarding Bayer, a company founded all the way back in 1863, which naturally faces hurdles in overturning long-established operating procedures.

Despite this inertia, new operational models are emerging to help bridge the gap between old practices and new demands. The dynamic shared ownership operating model, for instance, is already proving effective in helping these established organizations adapt to the new industry landscape.

The Path Forward: Preparing for the Foundational Future

The experts agree that AI and blockchain are not fleeting trends but essential, infrastructural elements that will form the backbone of clinical trials, much like the internet formed the backbone of global communication and commerce.

The future framework relies on a rising reliance on AI to set strategy, secure and transparent data management provided by blockchain, a necessary mindset shift to meet the needs of a new, informed patient population, and a dedicated focus on achieving sustainability goals through increased operational efficiency.

As the sector moves rapidly toward this foundational transformation, it is clear that embracing AI literacy and adopting new, efficient operating models—like the shared ownership model—will be vital for companies and professionals aiming to remain relevant and secure in the redefined clinical trial landscape.