BeiGene

Stefano Ferrara

AI Adoption Advisor

Through this article, Stefano Ferrara, shares his insights on the impact of AI on the clinical development and CRO industries. He emphasizes that that AI will not lead to job losses in the clinical development field, but rather will transform it.

As a seasoned clinical developer, I have seen many changes in the last 25+ years, and sometimes these changes affected heavily the way we develop a new compound, particularly in Oncology. The same approach may be used for the CRO business; years ago, the CRO support was limited to monitoring and site management, today most of the bigger CROs are like Amazon offer you everything related – or not – to a clinical trials.

The raise of AI generated questions about the future of a clinical developer job and the impact on the CRO business. The big question is will I lose my job? Do we still need CROs to handle clinical trials?

First of all, we need to understand the background of clinical development activities and the rationale to work with a CRO.

A clinical developer is – or should be –a strategic position with the goal to explore, define and design a clinical development plan to bring a compound as soon as possible on the market, without exhausting the budget of a company. This position requires strategic acumen, operational knowledge, disease knowledge, investigators network and other more skills. Of course, depending on the responsibility, you may have senior or junior role, but ultimately the clinical developer is responsible to define an accurate profile in terms of safety and efficacy for a given compound.

A CRO is a partner and a service provider to support a company who can’t or does not want to build a full team to execute clinical trials and wants to outsource some activities.

So, where can AI impact this? Likely, many activities may be accelerated and optimized through AI, just thinking on some data review, discrepancy management, data collection, and so on. Same for clinical development, the supportive data for a clinical developer plan can be found and elaborated much faster with an AI tool.

However, there are still many steps to be taken before we can consider AI as a reliable tool, and most of these steps are related to three words:

● Digitalization

● Harmonization

● Validation

Deep diving into these three topics, we can see that most of the hospital are far from a real data digitalization, and where we see it, rarely the different platform speak the same language, even inside the same hospital. It’s crucial that the data are managed and handled with a common language in order to transfer the information effectively and with high quality. Last but not least, this process should be validated also from regulatory authorities to ensure the reliability of the tool.

Having said that, it’s no doubt that the use of AI may speed up the clinical development process, allowing the patients to benefit earlier from access to innovative medicines.

In summary, should we be scared of losing our job and should CROs be worried to lose their business? In my opinion, not at all. If we are able to focus on competence, skills and strategic vision, AI will only be an additional tool to help us in delivering more efficacious and safe drugs. We may need less operational activities; likely source data verification (SDV) will be no longer needed, but data review and interpretation will require more people to read and understand the huge amount of data we will receive.

We will take decisions based on unprecedented amount of data collected very quickly. Understanding, interpretation and ability to take decisions will remain in the hand and brain of the developer. AI is a challenge that we can manage, in order to win battle with cancer.