Generative AI could help accelerate clinical development - Thoughts from the Centre | Deloitte UK

By Andrew Bolt, principal, and Amy Cheung, principal, Deloitte Consulting LLP

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For this week’s blog, we have repurposed a blog that was originally published by our colleagues in the US Deloitte Center for Health Solutions in December 2023, exploring the potential for generative artificial intelligence (AI) to accelerate clinical development.1 We identified the potential of AI to transform the traditional linear and sequential clinical trial process in a report we published in February 2020 (Artificial Intelligence in Clinical Trials), but as demonstrated in the US blog, the use of generative AI offers the prospect of even greater improvements, such as accelerating decision making.2 This in turn can reduce clinical development cycle times and further reduce the costs and burden of clinical development. Importantly, when it comes to clinical trials saving time translates to saving lives, or at least improving them, through faster availability of treatments.

In today’s challenging economic environment, leaders in life sciences are often faced with the difficulty of executing flexible and adaptable clinical trials that can serve the unique needs of various stakeholder groups in a cost-effective manner. This is not an easy task given that clinical trials are inherently labor intensive, complex, and regulated.

Novel digital technologies, automation tools, and patient-experience solutions have helped mitigate manual activities, and in turn, reduce overall cycle time and cost. However, these digitisation tools have historically had only an incremental, not transformational, impact on clinical trials. Generative artificial intelligence (AI) might finally be the technology innovation that can be a transformative lever.

Notably, generative AI has the potential to slow rising costs and transform the landscape of clinical development by accelerating tasks across the clinical lifecycle. That could help bring a greater share of services back within the four walls of biopharma companies, while improving experiences for internal resources and patients alike, and ultimately contributing to more efficacious therapies.

Three processes that could be improved with generative AI

Generative AI is already transforming the way life sciences organisations decide which disease areas to invest in. It is also being used to identify targets, develop molecules, streamline and accelerate clinical trials, and submit findings for regulatory approval (see Can Life Sciences companies unlock the full value of GenAI?). Here is a look at the role generative AI might play in several aspects of a clinical trial:

  1. Automate document generation activities to increase velocity:Generative AI could help biopharma organisations quickly draft and refine the documentation required to establish new test sites. The technology could use previous examples of clinical-trial protocols, site-contracting agreements, clinical report forms, and other key pieces of paperwork required to jumpstart clinical trials. Automating document generation could be a critical step in creating diversity within patient cohorts, allowing sites in under-served geographies to be established more quickly and with less effort.
  2. Increase study retention by amplifying patient engagement:Attracting and retaining patients can be a major pain point for clinical trial sites. Generative AI can help facilitate patient recruitment by activating personalisation at scale. It can also identify the doctors and ZIP codes of potential participants who could benefit from a new therapy and create customised outreach. The conversational nature of generative AI can function as the front-line in answering patient questions, sharing relevant information, and triaging the concerns that can cause patients to leave clinical trials early. Attrition can cost as much as $20,000 per patient. That expense gives organisations a significant incentive to explore all avenues for retaining clinical trial participants. 
  3. Improve regulatory engagement with tailored submissions:To successfully deliver a submission to regulators, clinical teams typically must assemble immense dossiers that draw from all of their laboratory research and clinical development activities. Automated generative AI-enabled document tagging can make critical documents easier to locate. For example, intelligent or semantic search capabilities enabled by generative AI—wherein a search is based on meaning rather than individual key words—can enable much faster identification of relevant materials.

Three considerations to ensure the effective use of generative AI

Many of the life sciences leaders we talk to are excited by the potential of applying generative AI to clinical trials. They are also understandably concerned about managing risks to quality and employee experience. To that end, we provide the following considerations:

  • Recognise the difference between a ‘task’ and a ‘job’: As generative AI use-cases grow, there are concerns that there will be less need for human workers. While this might be a valid concern, life sciences leaders should clearly differentiate between a task(i.e., an activity someone performs as part of their work) and a job, which typically has a far greater scope. Clinical development is made up of a variety of tasks that might be ripe for automation (e.g., repetitive, manual, and rule-based activities). The jobs that are attached to those tasks, however, remain critical.
  • Anticipate a shift toward more specialised knowledge: As discrete tasks are increasingly shifted toward generative AI, organisations will likely need to stand-up the proper guardrails to ensure the integrity of the outputs. Generative AI is expected to increasingly drive content creation (e.g., outreach to trial participants, plain language summaries of clinical data) and, as a result, humans will likely need to validate those outputs.
  • Be cautious of historical data: Clinical development has faced challenges related to creating diverse clinical trial cohorts. For that reason, leaders in R&D should be careful not to over-index on historical clinical data or they risk amplifying biases inherent in existing data sets. Moreover, ensuring that trustworthy AI frameworks and governance approaches are in place will mitigate potential for bias and unintended outcomes.

Combining generative AI with other digital platforms such as machine learning and predictive analytics could create an end-to-end business value stream—from clinical study startup through clinical study closeout.

Acknowledgments: Aditya Kudumala and Adam Israel

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Andrew Bolt, Principal, Deloitte Consulting LLP

Andy has more than 20 years of experience working in the life sciences industry. His career spans from bench scientist to CEO and he currently serves as a trusted advisor to life sciences industry R&D executives. Prior to Deloitte, Andy served as the CEO and founder of SphynKx Therapeutics, an early stage biotechnology company.

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Amy Cheung, Principal, Deloitte Consulting LLP

Amy Cheung is a Principal in Deloitte Consulting’s Life Sciences practice specializing in R&D. Amy has over 15 years’ consulting experience in the pharmaceutical industry. She worked for Merck as a researcher in chemistry prior to receiving her MBA. At Deloitte, she worked with clients to develop and implement options for productivity improvements and cost reduction; design and implement new operating models, governance and organizational structures.

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1 https://www2.deloitte.com/us/en/blog/health-care-blog/2023/generative-ai-could-help-accelerate-clinical-development.html

2 https://www2.deloitte.com/content/dam/insights/us/articles/22934_intelligent-clinical-trials/DI_Intelligent-clinical-trials.pdf

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