Medidata Drives Clinical Trial Digital Transformation in China with AI, Partnering Nearly 600 Domestic Pharma Companies

Over the past decade, the number of new clinical trials initiated in China has shown a year-on-year increase. Data from the white paper “The Landscape of Clinical Trials in China” reveals that the number of Phase I–IV trials launched domestically stood at 1,785 in 2016 and doubled to 3,641 by 2020. Globally, China’s total volume of clinical trials has long secured the second position, trailing only closely behind the United States.

As a witness to and participant in this transformation, Medidata, a wholly owned subsidiary of Dassault Systèmes, has been collaborating with Chinese pharmaceutical companies to advance clinical trials. As of June 2023, Medidata had partnered with nearly 600 domestic pharmaceutical companies and more than 40 contract research organizations (CROs), supporting over 3,160 clinical trials in which a total of 480,000 patients and healthy volunteers participated, thereby establishing itself as a key leader in the digital transformation of China’s life sciences sector.

On September 7, 2023, Medidata’s 12th NEXT China Annual Conference was grandly held in Shanghai.

Centered on the theme “Uniting Hearts and Minds, Envisioning the Future,” the summit has invited nearly 30 distinguished guests to focus on three key areas: “Risk-Controllable Intelligent Patient Journeys,” “AI-Driven Data Management and Insights,” and “Digital and Intelligent Drug R&D.” Participants will share digital innovation achievements spanning the entire product lifecycle and jointly explore the development direction of digital and intelligent applications in the life sciences industry.

During the event, VCBeat conducted interviews with Fareed Melhem, Senior Vice President of Dassault Systèmes Medidata and Global Head of Medidata AI, and Li Wei, Vice President of Dassault Systèmes’ Life Sciences Division and General Manager of Medidata Greater China. The discussions aimed to clarify Medidata’s leadership strategy while gaining insights into its future trajectory.

While the rise in the number of new clinical trials is encouraging, the number of trials that successfully reach completion remains limited due to numerous operational challenges.

Fareed Melhem summarizes the three primary causes of clinical trial failures. First is trial design: approximately 15% of trials fail due to flaws in protocol design, while many others suffer from defective designs that require continuous modifications during execution, resulting in significant waste of time and money. Second is patient recruitment: around 90% of clinical trials are delayed because they fail to enroll a sufficient number of subjects. The resulting project delays not only impose additional labor and opportunity costs on companies but also cause patients in urgent need of treatment to miss the optimal therapeutic window. Third is efficacy and trial evidence: approximately 40%–50% of trials fail due to an inability to obtain robust evidence demonstrating drug efficacy, a setback that many innovative enterprises cannot afford.

Having identified the root causes of the issues, the next step is to apply targeted solutions. In Fareed Melhem’s view, all the aforementioned problems can be addressed through data processing technologies and AI.

In terms of trial design and evidence generation, Medidata AI can predict which patients are likely to achieve the best therapeutic outcomes and which patients may experience adverse reactions, thereby enabling proactive measures to mitigate adverse events or safety issues. In clinical data management, Medidata AI automates the verification of all data collected during trials, enhancing efficiency and reducing the workload for data managers. During trial execution, Medidata AI leverages historical clinical trial data to make predictions, assisting sponsors in selecting appropriate investigative sites and classifying the hundreds or thousands of documents generated throughout the trial. Regarding patient engagement, Medidata AI facilitates the identification of digital biomarkers and other data, further reducing the burden on patients participating in clinical trials.

Furthermore, Medidata helps pharmaceutical companies design superior clinical trial protocols by leveraging application data. Fareed Melhem stated that patient enrollment is a major challenge in clinical trials; most trials fail to complete enrollment within the scheduled timeframe, thereby extending trial duration and increasing costs, and potentially even preventing the entire clinical trial from being completed as planned. Through its Medidata AI Intelligent Trials solution for site selection and prediction, Medidata can predict and identify sites suitable for conducting the trial based on its specific characteristics and context. Additionally, Medidata uses data-driven forecasting to ensure that trials proceed according to plan, adjusting predictions in real time as new data becomes available.

Revisiting the Issue of Patient Enrollment. Patients’ initial motivation for participating in trials is often to join the experimental group rather than the control group, particularly among those with severe illnesses. Is there a way to increase the proportion of patients in the experimental group while ensuring the validity of clinical trials? Medidata AI-generated synthetic control arms offer a solution.

In 2020, the U.S. Food and Drug Administration (FDA) approved the use of Medidata AI Synthetic Control Arm® synthetic control solution in Medicenna Therapeutics’ Phase III registrational trial of MDNA55 for recurrent glioblastoma (rGBM). In this trial, Medidata successfully helped Medicenna reduce the enrollment of 100 control patients, marking a pioneering effort in adopting hybrid external control arms for rare disease trials. The application of the synthetic control arm increased the probability of enrolled patients receiving the investigational drug, improved enrollment rates, and accelerated the trial process without compromising the scientific interpretability of the study.

With the further advancement of AI, algorithms are poised to address existing gaps in generative logic, ensuring that synthetic data not only maintains high quality but also accelerates the generation process and scales up volume. Under this trend, Medidata AI solutions are expected to benefit a broader patient population beyond those with rare diseases, while supporting more clinical trials by enhancing data management and trial design, optimizing trial insights, and improving overall trial efficiency.

Although no case involving Medidata’s synthetic control arm solution has yet received approval from the Center for Drug Evaluation (CDE), the company has already made significant contributions to advancing clinical trials in China.

As of September 2023, the Medidata platform has provided support for all PD-1 inhibitors currently included in China’s National Reimbursement Drug List; it has also participated in clinical trials for all domestically developed oral COVID-19 therapeutics marketed in China (including those from Junshi Biosciences and Simcere Pharmaceutical). Furthermore, Medidata has been involved in the development of all 23 major Chinese innovative drug license-out deals (each valued at over USD 500 million), covering nearly all prominent and novel therapeutic targets.

Related achievements continue to expand alongside Medidata’s increased investment in global innovation. This year, Medidata’s Shanghai office has established a new landmark. By setting up roots in Lujiazui, Pudong, Shanghai—a key hub for the life sciences industry—Medidata, together with its parent company Dassault Systèmes, remains committed to the philosophy of “In China, For China, Growing with China.”

As innovative technologies are implemented on the ground, Medidata’s local service team in China is continuously upgrading and refining its capabilities. By leveraging global experience, cutting-edge technologies, and specialized expertise, the team is further advancing the application of frontier digital-intelligence solutions—such as DTC and AI—in China. This helps Chinese clients accelerate clinical trials more effectively, thereby driving the development of the entire pharmaceutical industry and bringing greater benefits to more patients.