Medidata: Challenges and coping strategies for overseas clinical research of innovative drugs in China

Today, with the increasingly fierce competition in the global pharmaceutical market, China's innovative pharmaceutical companies are ushering in unprecedented development opportunities. With the growing demand for high-quality drugs in the international market and the continuous optimization of the domestic pharmaceutical innovation environment, more and more Chinese innovative pharmaceutical companies have begun to look to overseas markets and seek broader development space. However, in this process, Chinese pharmaceutical companies are facing many challenges and difficulties. Recently, Yan Xiaoming, Senior Manager of the Strategic Consulting & Solutions Business Unit of Dassault Systèmes Medidata Greater China, and Song Le, Senior Solutions Expert of Greater China, had an in-depth discussion on the dilemma of overseas clinical research of China's innovative drugs and how Medidata can use AI and other technologies to provide solutions for pharmaceutical companies.

Three major challenges in overseas clinical research

2023 is undoubtedly a milestone year for China's innovative drugs to go overseas. Since the successful approval of zanubrutinib in the U.S. in 2019, although the drug has continued to gain new indications in the following years, few domestic pharmaceutical companies have been able to commercialize their drugs overseas with their own commercialization teams, which is also due to the challenges and impacts of the epidemic. However, with the arrival of the second half of 2023, BeiGene's tislelizumab has been approved by the EMA and FDA, and Hutchison Whampoa's fruquintinib, Junshi's PD-1 and Yifan Pharma's innovative drugs have also been approved by the FDA.

At the same time, we also see that China's innovative drugs still face many difficulties in going overseas. Yan Xiaoming said that the first difficulty was the challenge of research design. Due to the differences in disease treatment standards and clinical practices between China and abroad, pharmaceutical companies need to fully understand and adapt to the treatment status and regulatory requirements of the target market when designing clinical trials. However, because the medical sector relies heavily on published literature, which is often based on marketed drugs and population-specific studies, there is uncertainty in the exploration of uncharted territory.

"By leveraging historical clinical trial data and AI algorithms, Medidata can help pharmaceutical companies quickly find information on niche and competing drugs, and provide strong support for pharmaceutical companies to formulate research strategies, which can not only reduce uncertainty in the decision-making process of pharmaceutical companies, but also improve the pertinence and effectiveness of research. Yan Xiaoming said.

In addition to the challenges of study design, research execution and research quality are also difficulties that need to be overcome in the process of China's innovative drugs going overseas. Yan Xiaoming pointed out that domestic pharmaceutical companies lack practical experience in global trial centers, and it is difficult to control the recruitment speed of overseas research centers, which may lead to lower than expected trial enrollment stage. In addition, 100% SDV (Source Data Verification and Confirmation) is generally used in China, while risk-based monitoring is more used abroad, which not only increases the cost of adaptation for pharmaceutical companies, but also may affect the quality of trial data.

Medidata also provides targeted solutions for this. In terms of research operations, Medidata uses big data and machine learning technology to predict and analyze the recruitment speed of global trial centers to provide pharmaceutical companies with scientific enrollment plans. At the same time, through real-time monitoring and analysis of trial progress, it helps pharmaceutical companies find and solve potential problems in a timely manner to ensure the smooth progress of the trial. During the study execution phase, Medidata offers flexible monitoring options to support pharmaceutical companies to adopt a risk-based monitoring approach or a traditional SDV approach based on their actual needs. In addition, Medidata uses technologies such as electronic clinical outcome assessments (eCOAs) to improve the accuracy and efficiency of data collection and meet international regulatory requirements.

"As the world's leading provider of life sciences cloud solutions, Medidata is committed to advancing pharmaceutical discovery through innovative technologies. In response to the difficulties encountered by China's innovative drugs in going overseas, Medidata has supported the approval of 4 domestic innovative drugs in the FDA and EMA based on a comprehensive solution. Yan Xiaoming said.

Digital health technology has become an important engine

Nowadays, digital health technology (DHT) is playing an increasingly important role, not only changing the traditional drug research and development model, but also providing a new path for Chinese innovative pharmaceutical companies to integrate with international standards. DHT is not only a technical concept, but also a new medical and health service model, which realizes the organic combination of remote data collection, clinical research participants and medical applications through electronic platforms, networking, software, sensors and other technical means.

"At present, the most widely used DHT technology in China and abroad is eCOA/ePRO technology. Song Le said that eCOA (electronic clinical outcome assessment) and ePRO (electronic patient-reported outcomes) are playing an increasingly important role in clinical trials of drug development, which can more accurately collect and analyze patients' clinical data and provide strong support for the efficacy and safety evaluation of drugs.

Song Le further explained that eCOA determines the key data layer for the successful marketing of clinical investigational drugs. The electronic collection of clinical outcome evaluation data can not only improve the accuracy and completeness of the data, but also reduce the impact of human factors on the data, so as to ensure the scientific and reliable drug development.

In terms of ePRO, Song Le pointed out that patients are one of the main contributors to the data, and the results reported by them are also of great significance for drug development. By collecting patient-reported data electronically, we can better understand the real feelings and medications of patients, and provide more comprehensive information for the efficacy and safety evaluation of drugs.

In addition to eCOA/ePRO technology, Song Le also mentioned the current hot DHT technology in Europe and the United States - wearable sensors. She emphasized that this sensor technology is different from the smart bracelets and smartwatches that consumers use every day, and it must undergo strict medical-grade certification to ensure the reliability and accuracy of the data. Although the application of wearable sensors in clinical trials in China is still relatively small, with the continuous development and improvement of technology, it is believed that there will be more breakthroughs and applications in this field in the future.

When it comes to the reasons why DHT has received so much attention and attention, Song Le believes that there are four main aspects. The first is the global spread of patient-centricity concepts. DHT technology can improve the patient experience and reduce the burden of participating in clinical research, making drug development more in line with the needs and expectations of patients. The second is the safety monitoring of patients after the use of new drugs. Through DHT technology, the feedback data of patients after medication can be continuously and uninterruptedly collected, and potential safety problems can be detected in time to ensure the safety of patients. In addition, DHT technology can also improve the efficiency and accuracy of clinical research, shorten the drug development cycle, and reduce the cost of research and development. Finally, with the rapid development and popularization of digital technology, DHT technology has also been more widely used and promoted.

"Some Chinese innovative pharmaceutical companies have begun to try to apply DHT technology to drug research and development in overseas markets, and have achieved remarkable results. The data collected by these companies through DHT technology not only improves the quality and efficiency of drug research and development, but also enhances communication and cooperation with overseas regulatory agencies, providing strong support for the internationalization process of drugs. Song Le said.

Of course, DHT technology also faces some challenges and problems in the application process. Song Le pointed out that how to ensure data security and privacy protection is one of the important issues. In addition, factors such as laws and regulations, healthcare systems, and cultural backgrounds in different countries and regions may also have an impact on the application of DHT technology. Therefore, when applying DHT technology, it is necessary to fully consider these factors and formulate corresponding strategies and measures to ensure the compliance and effectiveness of the technology.

Looking forward to the future, Song Le is full of confidence in the development of DHT technology. She believes that with the continuous advancement of technology and the expansion of application scenarios, DHT will play a more important role in many fields such as innovative drug research and development, clinical trials, and patient management. At the same time, she also called on more enterprises and institutions to join the research and application of DHT technology to jointly promote the competitiveness and influence of China's innovative drugs in the global market. (Text/Medical Valley Network Kathy)