Automation and artificial intelligence (AI) are advancing at lightning speed in numerous industries. While the clinical trials industry has always been a laggard in innovation, we will start seeing these technologies significantly impacting the way biopharmaceutical enterprises run clinical trials. While we are seeing some biopharmaceutical companies launching novel pilots (take digital health and digital endpoints in clinical trials, for instance), few are thinking about how automation will disrupt the clinical trials industry as a whole, as well as to how this movement will impact patients. In this article, I will discuss my opinions on how automation and AI will transform the clinical trials industry.

Clinical operations: the biggest cost in clinical trials and the easiest opportunity

While the biopharmaceutical industry is focusing on finding novel digital endpoints, and new processes, the fact is that clinical operations (i.e., source document verification, monitoring, study administration, site retention, and clinical research associate costs) represent approximately 50% of all clinical trial costs¹. It is a no-brainer to target automation on clinical operational costs, as (a) small pilots can be run with high success rates, since many clinical operational activities are business process in nature, and (b) biopharmaceutical enterprises can realize cost savings immediately by implementing automation. By estimation, I suspect that targeting clinical operations with automation can save more than 35% -40% in overall clinical trial costs.

Abundance: what happens when you automate an industry

When an industry becomes more automated, the phenomenon of abundance comes into play. One of the most significant rate-limiting factors hindering emerging biopharmaceutical companies is the high cost (and associated risks) of launching and running clinical trials. What happens when the cost of clinical trials no longer becomes a hindrance? An explosion of new biopharmaceutical enterprises and clinical trials. Abundance will drive therapeutic innovation and the number of clinical trials to new heights, and that will increase the frequency of novel therapies entering the market. 

Abundance will open new markets

The clinical trials industry will become a very active space and will become available to a new prospect: emerging biopharmaceutical companies that have a need to run low-cost studies. Those companies will seek technology-driven CROs to service their clinical trials at a lower cost. Digital health enterprises that support decentralized trials will also become high in demand.

Abundance means cheaper therapies to patients

The high amount of clinical trials will also surmount to greater medical product supply and competition in the marketplace. Payers will be at a more significant advantage, as they can select coverage from a variety of therapeutics, and patients who were previously unable to afford expensive medical products will be able to afford them. The biopharmaceutical industry will open a new marketplace: inexpensive and commoditized therapeutics targeting more massive patient population bases.

What can biopharmaceutical executives do to become a part of this new wave?

The biopharmaceutical industry can do many things to jump onto this new wave. Tools, such as AI, are now becoming commoditized by cloud technology enterprises, and are accessible to virtually anyone. For instance, Google Cloud AIoffers imaging AI, natural language processing, speech to text, video AI, and machine learning platforms. Biopharmaceutical executives can easily access this technology to run pilots on their own clinical operations and realize immediate efficiency and cost savings in clinical trials. Imagine developing a site engagement technology that learns and notifies sites before they start to lose engagement or applying automation towards site startup activities. The key is to start small pilots on easy to tackle operational activities that yield a high chance of success, build internal credo amongst colleagues and executives, and continue to build on new processes using these tools.

Those who do not jump on this new wave of technology will undoubtedly be left behind and become a dinosaur company, whereas those who do will enter a new realm of competition, and those who jump in first will gain a significant competitive advantage.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.

References:

[1] https://www.clinicalleader.com/doc/getting-a-handle-on-clinical-trial-costs-0001