Leveraging AI for Precision and Equity: A Novel Approach to Endpoint Data Collection in Clinical Trials
By: Todd Rudo, Chief Medical Officer at Clario
Kim Nguyen, Director of Data Science at Clario
Leveraging AI for Precision and Equity: A Novel Approach to Endpoint Data Collection in Clinical Trials
By: Todd Rudo, Chief Medical Officer at Clario
Kim Nguyen, Director of Data Science at Clario
Clario harnesses the power of AI with robust data sets and predictive analytics that truly mirror the diverse tapestry of our society.
In recent years, artificial intelligence (AI) has emerged as a powerhouse with the potential to revolutionize the collection and interpretation of endpoint data in clinical trials. Its capacity to manage vast amounts of data — from medical records to diagnostic images — while identifying underlying patterns is fundamentally transformative for the development of new therapies.
Yet, with the rapid proliferation of AI technologies in healthcare, a critical eye must be cast on health risks and potential biases that might emerge. At Clario, we are committed to helping our partners unlock richer data in their clinical trials, but gathering evidence must be accomplished in the right way. We recognize that the road to leveraging the full potential of AI is promising but it is also paved with complexities that require careful navigation as we integrate it into our technologies and solutions.
Power and Responsibility in AI
Today's medical applications of AI are primarily focused on enhancing the accuracy and efficiency of diagnoses and tailoring treatment plans. The heart of these AI tools lies in the data — more precisely, the accuracy and comprehensive nature of the data used in training the models. Predictive analytics, powered by AI, takes this a step further, analyzing past and current data trends to make future predictions about patient outcomes and trial successes.
AI is also impacting the urgent need for enhancing diversity in the recruitment and retention of clinical trial participants, to ensure trial populations match the epidemiology of the target diseases. Both inclusivity and strengthening the predictive accuracy of AI tools are essential to improving trial and patient outcomes. A comprehensive, diverse dataset ensures that AI algorithms can discern health indicators across varied demographics, marking a shift towards a universally beneficial healthcare standard.
Committing to Technologically Diverse Strategies
Collection and analysis of clinical trial data have benefited from a slew of remarkable AI-driven innovations over the past five years. In that short period of time, our scientists at Clario have developed and applied more than 30 AI-enabled solutions across our technology platform. These advancements include deploying innovative tools for real-time evaluation of radiologic images, providing quality assessments and preliminary interpretations to reduce errors, improve data quality and streamline operations. We have also formed strategic collaborations, such as a recent partnership with ArtiQ, which has enabled us to offer real-time, automated evaluations of flow-volume loop quality for improved data accuracy.
What’s more, a crucial component of our AI strategy is the emphasis on developing predictive analytics. Our data scientists are innovating powerful new models that incorporate relevant imaging and clinical data that is processed to predict population outcomes within clinical studies. By training our AI models on robust datasets, we can better predict patient responses, anticipate specific study events and help sponsors strategize enrollment, maximizing the value of each study supported.
“Our commitment to using robust datasets that mirror the diversity of the disease population helps mitigate bias, fostering trust and reliability in the AI-enabled tools we develop.”
— Todd Rudo, Chief Medical Officer, Clario
Navigating Regulatory Evolutions with Forethought and Inclusivity
The regulatory environment surrounding AI is complex, necessitating a nuanced understanding of bioethics and a commitment to adherence to varying regulatory guidelines like the EU AI Act and the US AI Bill of Rights. One of the key elements in these guidelines is the importance of transparency in model development, which serves to reduce the "black box" apprehensions often associated with AI technology.
At Clario, our commitment to using robust datasets that mirror the diversity of the disease population helps mitigate bias, fostering trust and reliability in the AI-enabled tools we develop. We recognize the pitfalls of training AI models on incomplete or potentially inaccurate datasets. Only by incorporating the right data in training our models, will AI-enabled tools evolve to reliably support tailored healthcare outcomes. Prioritizing inclusivity, especially of historically marginalized communities in clinical trials, is ethically and scientifically sound from many perspectives, including the contribution to the development of tools that can best serve patients from a variety of backgrounds with a range of medical conditions.
Embracing the Future: AI, Predictive Analytics and Equitable Representation
AI’s potential to meaningfully impact clinical research is nearly limitless. Models to support predictive analytics, and to enhance data quality and operational efficiencies, will drive success in the conduct of clinical studies. From enhancing adaptability in study protocols and endpoint selection to ensuring patient safety, the tools under development today are sure to provide broad benefits to sponsors and patients alike. Our industry now has the opportunity to shape a new healthcare landscape enhanced by AI-enabled tools, marked by unmatched precision and efficiency. This is much more than innovation; it’s a substantial leap forward in data science, which used responsibly, will transform the pace of progress in developing therapies to address unmet medical needs worldwide.
ABOUT Todd Rudo, M.D.
Dr. Todd Rudo is the Chief Medical Officer at Clario. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials while minimizing patient and site burden.
ABOUT Kim Nguyen
Kim has 15 years of healthcare experience, supported by his Data Science Master's from UC San Diego. His academic journey included groundbreaking Alzheimer's imaging research using electron microscopy, collaborating with a dedicated team during his graduate program. In his current role as Director of Data Science at Clario, Kim is at the forefront of utilizing the latest machine learning techniques. His mission is to create advanced predictive models, harnessing the power of data to provide innovative solutions that drive results for Clario.