HLT & Evidera International Forum on Real-World Evidence Applications and Outlook Concludes Successfully

Nearly 100 domestic and international guests from more than 20 pharmaceutical companies, hospitals, universities, and related institutions attended the forum. Packed with valuable insights, the event featured insightful presentations by industry leaders, which we have compiled for our readers’ benefit.

In her opening remarks, Ms. Yang Jing, President of HLT, stated that the transformation from large volumes of unusable data to usable big data, and ultimately to the generation of evidence, is a systematic and long-term process. This process encompasses not only data but also related IT technologies, research methodologies, and study protocols, as well as the iterative enhancement of methodological rigor and levels of evidence.

Ms. Yang Jing introduced that HLT, in partnership with Evidera, is hosting this forum “with the aim of sharing and exploring how to integrate high-quality data with internationally standardized methodologies and research techniques. We hope to leverage our knowledge and experience to make our own contribution, befitting our era, to the development of the industry. The original aspiration behind the establishment of HLT was to promote green healthcare. We strive to support the industry, collaborate with domain experts to transform the relationship between humanity and disease, and focus on leveraging and developing medical data technologies to empower the industry, thereby enhancing the quality and efficiency of drug R&D, clinical research, medical research, and patient management. We are not merely participating; more importantly, we are jointly witnessing and creating our own era of big data in healthcare.”

Professor Yao Chen, Chair of the Evidence-Based Medicine Professional Committee of the Chinese Medical Doctor Association, Member of the Expert Advisory Committee for Drug and Medical Device Review at the National Medical Products Administration (NMPA), and Director of the Department of Medical Statistics at Peking University First Hospital, shared his insights and experiences accumulated over more than 30 years in the field of medical information.

Although the advantages of electronic data are becoming increasingly prominent, current hospital information systems remain fundamentally oriented toward administration and clinical care, failing to adequately address research needs. Consequently, most clinical studies still require manual transcription of electronic records, leading to issues with research integrity and management gaps. It is essential to motivate frontline physicians and data-handling researchers to ensure the quality of source data. Meanwhile, establishing a universal management process centered on source data—encompassing both source data for research content and source data for research processes—will create a complete, traceable management framework. With data standardization and proceduralization achieved, the formation of a data-sharing mechanism will follow naturally.

Furthermore, Professor Yao Chen emphasized in his speech, “Research should not focus solely on big data and publication of articles; rather, it should aim to practically address clinical issues by collecting and analyzing data with clear research objectives. Only high-quality real-world data will be accepted by regulatory authorities.”

Dr. Mel Formica, Global Head of Market Access Consulting at Evidera, pointed out in his speech that an increasing number of countries worldwide are emphasizing the application of Real-World Evidence (RWE). Even Germany, which places the greatest trust in Randomized Controlled Trials (RCTs), has adopted RWE as one of the guiding bases for drug reimbursement. A key factor driving this trend is technological advancement, which has significantly promoted the generation of high-quality real-world evidence.

The application of Real-World Evidence (RWE) spans the entire product lifecycle, as it addresses the diverse needs of regulators, payers, and other stakeholders, while supporting improved patient access and expanded clinical adoption. With the rapid advancement of novel therapeutic modalities such as precision medicine, cell and gene therapies, cancer immunotherapy, and treatments for rare diseases, the importance of generating RWE has become increasingly prominent. In recent years, there has been a growing number of cases demonstrating the successful use of RWE in submissions to health technology assessment (HTA) agencies, leading to favorable reimbursement outcomes. Looking ahead, with the development of mobile internet and artificial intelligence technologies, RWE will play an increasingly vital role in areas such as early market access for new drugs and long-term patient management.

Dr. Karen Kaucic, President of Evidera, introduced PPD as a leading global clinical research organization dedicated to providing drug discovery, development, lifecycle management, and laboratory services. By combining these capabilities with HLT’s big data technology and technological prowess in the healthcare sector, this powerful partnership “aims to address unmet clinical needs for pharmaceutical companies targeting the Chinese market, as well as for domestic innovative enterprises targeting the global market. It seeks to comprehensively empower clients at key stages, including IND registration, clinical trial protocol design, clinical trial quality management, and patient enrollment efficiency.” Evidera, a business unit of PPD, is a premier provider of real-world evidence (RWE) research, having published an average of 35 peer-reviewed articles annually over the past five years focusing on RWE methods or themes. HLT and PPD are committed to enhancing the global R&D capabilities of innovative pharmaceutical companies, helping more outstanding pharmaceutical enterprises and their products reach the global market.

Hao Yiming, General Manager of the Innovative Commercial Solutions Division at HLT, pointed out that the quality of real-world evidence (RWE) in China urgently needs improvement. He stated, “We need not only high-quality data but also highly skilled researchers who follow rigorous procedures to analyze data and derive reliable study conclusions. This can be achieved by drawing on international experience and enhancing application capabilities.” “High-quality data” is a core element of industry development and the foundation for sound business decisions. Achieving this requires efficient technical processing capabilities and the support of global process quality control experts.

Dr. Xiao Ning He from Tianjin University presented on behalf of Dr. Jing Wu, Professor at the School of Pharmaceutical Science and Technology, Tianjin University; Asia-Pacific Representative of the ISPOR Health Policy Science Committee; and Vice Chair of the Pharmacoeconomics Professional Committee of the Chinese Pharmaceutical Association. She shared insights into the current challenges facing real-world evidence (RWE) research in China. Taking electronic medical records (EMR) as an example, there is currently a lack of access pathways and sharing mechanisms, along with insufficient investment in funding and human resources. Furthermore, registry studies in China need to improve registration quality; it is urgent to develop multi-center registries and establish data linkages. Meanwhile, patient-reported outcomes (PRO) research lacks practical tools in Chinese and a utility scoring system based on the preferences of the Chinese population.

However, in recent years, China has made significant progress in the field of real-world evidence (RWE). For instance, as of December 2018, the Chinese National Rare Disease Registry System had registered more than 30,000 patients, and the China RWE Alliance (ChinaREAL) released five technical guidance documents in July 2019. Regarding the current challenges and recommendations for RWE in China, Dr. He Xiaoning expressed the hope that “the threshold for data access will be lowered in the future. In research practice, prospective studies or registries require prior knowledge of patient distribution and profiles; adding questionnaires to retrospective data can effectively compensate for data deficiencies.”

Dr. Radek Wasiak, Vice President of Evidera’s Global Headquarters, shared the “Framework for FDA’s Real-World Evidence (RWE) Program,” a major announcement made by the U.S. Food and Drug Administration (FDA) at the end of last year. This framework provides a relatively clear roadmap for achieving the goal of using RWE to support regulatory review and decision-making. It is believed that the China Food and Drug Administration (CFDA) will also gradually expand the application scenarios of RWE, which will positively impact shortening the approval timeline for innovative drugs, establishing special pathways for rare diseases and urgently needed medicines, and enhancing post-marketing risk management plans and studies.

In his address, Dr. Radek Wasiak emphasized that patient engagement has become a critical standard in contemporary research, as it effectively enhances patient recruitment rates, shortens recruitment cycles, accelerates new drug launches, and improves return on investment. Customized eCohorts can help improve the interpretation of patient data, thereby optimizing clinical development. Key steps include assessing patient populations, clarifying associations with existing data, collecting precise data to serve research objectives, and ultimately generating evidence or providing corresponding support. Meanwhile, it is hoped that future technological advancements will enable electronic medical records (EMR) to adequately support real-world evidence (RWE) studies, thereby reversing the current situation where healthcare reimbursement mechanisms and structured EMR systems fail to meet the needs of personalized medicine and rely heavily on manual data entry.

The Q&A session between the guest speakers and the on-site audience brought the interactive atmosphere to a climax, leaving all attendees with significant takeaways.

It is believed that the successful holding of this forum will further promote the development of real-world evidence (RWE) in China, help improve the level of clinical research in China, and play a positive role in accelerating the internationalization of RWE in China.

To watch the full forum video, please scan the QR code below to access the conference replay;

Full Video of the Forum