07/23/2024
Photo by Steve Johnson on Unsplash
On July 10th 2024, the US Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI) announced an upcoming hybrid public workshop “Artificial Intelligence (AI) in Drug & Biological Product Development” on August 6th, 2024 at 10:00am-5:30pm EST. AI refers the area of computer science that creates intelligent machines intended to mirror human cognitive functions such as learning, recognizing patterns and relationships within datasets, adapting, and problem solving. AI is already being put to use in the field of clinical research, some AI models are used create new trial designs by summarizing records of previous trials including the differences in their designs and final outcomes. Others are being used to enhance patient recruitment, a time and resource consuming stage of clinical trials, by using predictive algorithms to optimize eligibility criteria without increasing the risk to patient safety (For more information on how AI is currently being used to innovate clinical trials please see the following journal article from nature https://www.nature.com/articles/d41586-024-00753-x).
While AI has the potential to accelerate clinical trials, they must also be monitored and regulated throughout their implementation in order to ensure patient’s safety and rights are upheld. The upcoming workshop looks to discuss the guiding principles of responsible AI use in clinical trials through presentations and panel discussions with AI experts and drug developers. Four major topics will be discussed:
Optimizing model design through multidisciplinary expertise. Developing an optimal AI model will require input from experts in different fields such as:
Medicine
Statistics
Pharmacology
Data science
Engineering
Exploring strategies for overcoming common data-related challenges. This includes fit-for-use data availability, data quality issues such as bias and representativeness of data, and the use of synthetic data.
Balancing model performance, explainability, and transparency of AI models. This includes the need to have humans in decision-making processes.
Identifying key gaps and challenges hindering the use of AI. This will hopefully lead to actionable next steps in advancing the use of AI in drug development.
The full FDA notice about the workshop can be found here. Those who are interested in attending the workshop (attendance is free of cost) have the option of attending virtually through Zoom, or in person at the FDA Great Room, located at 10903 New Hampshire Avenue, Silver Spring, MD 20993. To attend you must first fill out the registration form at the following link: Registration. Those who register will receive a confirmation email after registration and those attending virtually will be emailed a link to the workshop. Clinical Pathways staff will be attending the workshop and will provide a summary of what was covered in a future blog, so keep an eye out!
-The Clinical Pathways Team
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