From Data to Treatment: Medidata's Fareed Melhem Discusses AI's Impact on Clinical Trials

As the potential of artificial intelligence (AI) continues to unfold, how is it revolutionizing the intricate landscape of clinical trials? How can vast reservoirs of data be harnessed to enhance patient experiences and accelerate drug discovery? Navigating the maze of global regulations presents its own challenges, but can these be surmounted with technological innovation? And in an era that emphasizes the importance of diversity and inclusion, how can we ensure that clinical trials truly reflect the diverse populations they serve?

In order to answer these and some other questions regarding the growing role of AI in clinical trials, I have talked to Fareed Melhem, Senior VP and Head of AI at Medidata, a Dassault Systèmes company.

Medidata, a provider of clinical trial solutions to the life sciences industry, recently announced a multi-year partnership expansion with Catalyst Clinical Research to support their global oncology brand, Catalyst Oncology. Through this extended partnership, Catalyst can continue to support over 150 oncology studies and manage more than 80 next-generation cancer clinical trials today across Phase I-III. Notably, around 90% of all oncology FDA approvals last year were developed using Medidata software.

Andrii: Fareed, the integration of AI into clinical trial processes is definitely a stride these days. Could you elaborate on how Medidata AI is utilizing artificial intelligence to further enhance the precision, efficiency, and success rates of clinical trials?

Fareed: At Medidata, we’re leveraging the power of AI to analyze the industry’s largest data set – so far, consisting of 30,000 clinical trials and more than nine million study participants – and to assist with the collection, analysis, and operational services for clinical trials. By better understanding and leveraging data, we can ultimately create detailed external control arms to allow for higher patient recruitment and retention, facilitate better study planning, select the most accurate sites and patients, and ultimately lead to better, faster, and safer trials.

The combination of Medidata’s technological solutions help us to improve patients’ experience in clinical trials by reducing the number of patients who receive an outdated standard of care, better detecting adverse events, and bringing treatments to market – and more importantly to patients – sooner.

Andrii: Given your extensive experience with international clients, how does Medidata adapt its technology and services to meet the diverse needs and regulations of global markets? Are there unique challenges or opportunities that you've encountered in different regions?

Fareed: What sets Medidata apart from other clinical trials providers is the immense breadth and depth of our data set and cutting-edge technology that our customers can utilize to execute their studies. We’ve standardized this clinical and operational data so that biopharmaceutical, medical device companies, and contract research organizations across the world can use Medidata AI to derive relevant insights that inform key decision making throughout their clinical trial program.This unique and robust dataset, combined with our over 20 years of industry experience and expertise, helps us to support the needs of our clients worldwide and address and comply with the different regulatory guidelines around the world.

Andrii: The report highlights the importance of real-time data access, scalability, and the capability for mid-study changes. How is Medidata staying ahead in understanding and anticipating the evolving needs of the industry, and ensuring its solutions are not just current but future-ready?

Fareed: Our data set is the foundation for all of our work and is critical to addressing the needs of our customers as they arise. A prime example of this in action is how we use our product, Medidata AI Intelligent Trials, throughout the clinical trial process – from study planning to execution.

Whether it is determining realistic timelines, establishing diversity goals and enrollment sites, and identifying opportunities to improve operational performance, our customers are seeing the benefit from our services. In fact, our top 10 pharma clients experienced a 6+ month acceleration of their clinical trials in a hyper-competitive indication due to our products.

Being quick to understand and address the needs and common pain-points of the clinical trial industry is crucial to continuing to be the leader of this complex and evolving landscape. In doing so, we hope to help customers get their treatments to patients faster, and with fewer roadblocks.

Andrii: Beyond the technology itself, Medidata's solutions significantly affect the pace and success of drug development, ultimately benefiting patients worldwide. Can you share a particular success story or impact narrative that resonates with you, where Medidata's technology made a notable difference?

Fareed: A great example of the power of Medidata AI is our collaboration with Every Cure, a nonprofit dedicated to drug repurposing. We are working with Every Cure to use the power of Medidata AI to unlock new uses for existing medicines across all disease areas. Earlier this year, we were able to identify the most promising treatment for an individual living with idiopathic multicentric Castleman disease (iMCD), a rare, life threatening condition.

Through this AI-guided discovery, the patient—who had exhausted all existing treatment options and was preparing for hospice care — was able to be successfully treated, providing hope to the individual and their loved ones, but also others living with the condition. This success story would not have been possible without the power of AI and reinforces our mission at Medidata which is ultimately to power smarter treatments and healthier people.

Andrii: Can you share insight into any upcoming technological advancements or innovations within Medidata AI that will continue to enhance and expedite the clinical trial process? Maybe some major plans for 2024 you can talk about?

Fareed: A significant area where we are continuing to invest and innovate as a company is helping our customers to ensure greater diversity, equity, and inclusion within clinical trials. Earlier this year, we launched the Medidata Diversity Program, the industry’s most comprehensive solution to this historically prevalent challenge.

AI in particular has been very effective in helping us to accomplish this goal. Medidata AI can promote greater inclusivity in trials by providing customers with baseline and benchmark data and actionable insights so they can integrate a more diverse patient population in their clinical trial program. It can also improve diversity in patient recruitment by identifying and screening potential participants and reducing biases found in manual recruitment processes.

For example, we collaborated with a large sponsor to benchmark their study’s diversity against that of industry performance. Our data and analytics showed the sponsor that they had a significant gap in their patient demographic make-up compared to the industry. We were then able to identify specific areas and means for improvement in order to increase diversity, and ultimately increase the understanding of the therapy’s effectiveness in a larger population

Topics: Emerging Technologies