Medidata: AI spearheading dramatic changes in clinical trials

Digital innovation and artificial intelligence are revolutionizing the pharmaceutical and life sciences sectors, with AI speeding up the process, according to speakers at the NEXT Shanghai 2023, a conference organized by Medidata, a Dassault Systèmes company.

Life sciences experts, scholars, and delegates gathered in Shanghai to discuss how artificial intelligence innovation is transforming the patient journey for clinical trial participants, providing improved data management and insights, and accelerating drug research and development.

Clinical trials have entered a new era marked by "dramatic changes," according to Fareed Melhem, SVP and Head of Medidata AI, who supervises a team of over 300 people.

The transformations include methods for collecting data for trials in more decentralized ways, such as sensors, video visits, apps, site visits, labs, genomics, and real-world data. It also includes data integration with diverse data sources to create a "clean, high-quality, and complete" data collection, depending on Medidata's AI investment and management, Melhem told Shanghai Daily in an exclusive interview.

Then AI is used to drive new insights, covering all processes from the initial design of clinical trials to study planning, execution, and evidence generation.

"We introduced our AI business a few years ago by finding smarter ways to design, recruit, and execute studies and generating solid evidence to support drugs' regulatory success," Melhem explained.

In fact, by acquiring, interpreting, and activating data, artificial intelligence is playing a critical role in innovative drug discovery and smart medical treatment. The advancement saves billions of dollars for biomarkers and gets novel treatments out as soon as possible.

For example, the Contract Research Organization (CRO) PPD combined their data with Medidata AI Intelligent Trials’ extensive performance data to confidently forecast double the initial patient enrollment rates with optimized country and site footprints. PPD reduced the number of planned countries by 34 percent, the number of planned sites by 42 percent, and the overall predicted research time by seven months.

Medidata, which officially entered the Chinese market in 2015, has watched the rapid ascent of Shanghai and China's pharmaceutical business, owing to the expedited new drug discovery and development processes. Medidata has supported over 3,160 clinical trials and over 480,000 patients enrolled with 600 customers and 40 CRO partners, making it a prominent leader in China's life sciences sector's digital revolution, according to the company.

With all of this data and complexity, artificial intelligence has the ability to assist individuals on the front lines of trials in making better judgments. However, AI must be used correctly, on the basis of reliable data, and in collaboration with the people and teams working to improve clinical trials, Melhem said in a recently published piece in Pharma Time Magazine.

Melhem pointed out that AI innovation will affect a few things in the future.

First, AI gives users, such as study planners, study managers, or a physician treating a patient, far more real-time access to information and suggestions around the best things to do.

Another focus is on making data and insights more accessible. This is where generative AI may help, by making it easier for non-technical users to gain insights directly from data "rather than having to know how to code in Python or build a dashboard," he said.

Several experts shared their perspectives on the practical application of digital solutions such as Decentralized Clinical Trials (DCTs), Electronic Clinical Outcome Assessment (eCOA), Randomization and Supply System (RTSM), and Risk-Based Quality Management at the NEXT Shanghai conference.