As artificial intelligence (AI) becomes more dominant in the pharma industry, regulators have started developing guidance as to how it can be used. There are complexities however, especially for sponsors conducting global trials using AI to abide by regulation from different regions.
The US Food and Drug Administration (FDA) is in the midst of developing guidance for the use of AI and machine learning (ML) in drug development and has already released guidance on the use of AI and ML in medical devices. The European Medicines Agency (EMA) has also released draft guidance on the use of AI in the medicinal lifecycle, covering both drugs and medical devices. On top of this, sponsors must also abide by local legal frameworks, such as the European Union’s (EU’s) AI act.
Go deeper with GlobalData
Without a team that can constantly keep on top of all these legislations, there is potential that a sponsor may not be complicit when designing and running a trial.
Singapore-based RegAsk has developed an augmented-AI chat bot, RegGenius which allow sponsors to ask questions about how they must abide across all regions. The chat bot provides information for all regulatory guidance.
The Clinical Trials Arena team spoke with RegAsk’s chief product technology officer (CPTO) Amenallah Reghimi about the new guidance’s and how this software provides the answers sponsors need, especially considering the ability for interpretation.
AB: How do you see AI regulation developing?
AR: Given the speed and evolution of AI regulation, it is important that sponsors have up to date, accessible information that is actionable. I anticipate that AI regulation will become more stringent and more comprehensive over the coming months and years, with a focus on ethical use and safety. I believe companies need to invest in an adaptable and robust compliance system to ensure that during changes it can remain compliant.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataAB: In regards to new AI guidance being released, there are differences between the FDA and EMA, how does RegGenius manage this for sponsors wanting to conduct large, global trials?
AR: That is one of the biggest challenges for RegGenius. Not only does regulation vary between countries but also between products. There are four levels we are working on with RegGenius to help here in tracking all the latest regulatory updates across the multiple agencies, ensuring that the user has always access to the most current information. RegGenius works behind the scenes, scanning regulatory sites daily to get the most up to date information. Finally, it will inform the user of upcoming guidance to be aware of so that can be taken into consideration.
AB: How does RegGenius ensure the information provided to sponsors is accurate for regulatory challenges in their trials?
AR: RegGenius will use the contextual information about the specific trial in question to help formulate a response. This is one of the most important parts of the software – the understanding that can be built in. The sponsor can feed in information so that the AI chatbot will have all the knowledge it needs about the trial it needs to properly formulate an answer. This includes information about the geography, the indication, the type of drug, the phase – all of this can change the regulatory considerations a sponsor needs to take. This is important because it reduces the possibility of AI hallucination.
AB: How does RegGenius manage interpretation within the guidance?
AR: This is a real challenge. Regulation, by default, is not black and white and sponsors often want black and white answers. To try and manage this, we have a pool of regulatory experts, both at an internal and external level. So if there is some interpretation, we can run a question by a few experts and decide the best practice. RegGenius connects the sponsor with a network of regulatory experts and consultant, who can then provide additional interpretation advice. AI is great, it’s people not technology that are the key to succeeding with AI. That’s why it’s always taking it back to that human expertise. That human expertise can bridge the gap between the open-ended guidance and the specific needs of the sponsor. The way it displays for the sponsor is by providing a generated response with references but then asking whether the sponsor wants that expert consultation. That is the best way we have found to navigate the complexities of AI regulation with confidence and precision.
AB: In regards to the experts who provide more guidance, where does the liability lie in case the guidance provided is ever incorrect?
AR: We have both an internal team which is customer facing and an expert network which is not. RegGenius connects with those external partners and those answers go through the internal regulatory affairs teams to be reviewed and validated. Because this is regulatory affairs, precision and confidence are very important, so we do not think it is wise to put the customer directly with the external expert.
