MedKarway Launches 'COPD Initiative' Phase I Report and Builds a Real-World Evidence Data Middle Platform

“Comprehensive research data covering the entire continuum of care for COPD patients—from hospital admission and discharge to follow-up—constitutes a critical foundation for analyzing the real-world safety, efficacy, and pharmacoeconomic value of various medications,” stated Dr. Yang Ding, Director of the Department of Respiratory Medicine at China-Japan Friendship Hospital, at the 2019 Summary Meeting of the China COPD Tiered Diagnosis and Treatment Project held in Beijing.

However, the underdiagnosis and inadequate treatment of chronic obstructive pulmonary disease (COPD) in China have made the collection of scientific research data on this condition a challenging task.

In 2018, the “COPD Special Project” was established under the advocacy of Academician Wang Chen, relying on the National Clinical Research Center for Respiratory Diseases and the Chinese Respiratory Specialist Medical Consortium.

As the first registry study on acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in China, this study fills a gap in clinical research on COPD in the country. It also serves as the largest and most influential real-world research platform for COPD in China, providing a solid foundation for the development and capacity building of the national clinical research system for COPD.

One year since the establishment of the COPD Special Project, its reach has been rapidly expanding with the support of MedCoffee. On this year’s World COPD Day, Dr. Yang Ding, Director of the Department of Respiratory Medicine at China-Japan Friendship Hospital, released the analysis report on the Phase I results of the Clinical Research Special Project for Chronic Obstructive Pulmonary Disease (hereinafter referred to as the “COPD Special Project”). Dr. Yang pointed out that the COPD Special Project has currently engaged 265 tertiary and secondary hospitals, covering landmark Western medicine and traditional Chinese medicine hospitals across all provinces, municipalities, and autonomous regions, with nearly 10,000 cases of COPD-related data submitted.

In real-world studies, real-world data (RWD) are diverse and voluminous, yet real-world evidence (RWE) remains scarce. Constrained by certain key deficiencies in the level of hospital informatization in China, it is extremely challenging to transform large amounts of single-dimensional RWD into RWE.

The COPD Collaborative Network is a model example of the “data middle platform” construction for real-world studies by MedCoffee.For all stakeholders, the “COPD Collaborative Network” provides a robust “data bank” for subsequent mining of the value of scientific research data.

Zhang Yaowen, Medical Director of MedCoffee, stated, “Through the COPD-specific initiative and the National Clinical Research Collaboration Network for Respiratory Diseases, higher-quality and more reliable real-world evidence will be generated. These data will provide substantial support to governments, healthcare institutions, patients, and pharmaceutical and medical device companies, carrying significant social implications and economic value.”

First, through specialized initiatives on chronic obstructive pulmonary disease (COPD), we can gain a more effective understanding of the risk factors, etiology, and pathogenesis of COPD in China, which holds significant importance for regional policy formulation, disease mapping, and new drug development;

Second, evaluate the benefits and risks of current clinical diagnosis and treatment for patients with chronic obstructive pulmonary disease (COPD), conduct comparative effectiveness studies of Chinese and Western medicines in natural populations, and perform more comprehensive assessments of respiratory pharmaceuticals and medical devices (such as ventilators) in terms of efficacy, safety, medication regimens, and economic benefits.

Third, during the diagnosis and treatment of chronic obstructive pulmonary disease (COPD), explore the optimal traditional Chinese medicine (TCM) treatment regimens through clinical medical evidence, thereby providing an objective basis for TCM and integrated traditional Chinese and Western medicine therapies for COPD;

Fourth, for drugs that have already been marketed, long-term clinical practice may reveal the need to expand their indications. This is particularly evident in the fields of pediatric medication and traditional Chinese medicine (TCM), where off-label use is common in clinical practice.As an effective complement to randomized controlled trials (RCTs), real-world studies can significantly reduce the time and cost associated with indication expansion or new drug development.

Fifth, it can address issues such as standardized diagnosis and treatment of chronic obstructive pulmonary disease (COPD), rational medication use, and the impact of medication adherence on long-term prognosis; monitor these aspects in medical quality control and patient health management; propose optimization strategies; and provide a basis for the design of subsequent research studies.

Given the prolonged course and complexity of respiratory diseases, as well as the fact that a large proportion of patients are managed at the primary care level, clinical data collection and research collaboration in respiratory specialties require coordination and cooperation among tertiary hospitals, secondary hospitals, and primary healthcare institutions and physicians. To build a high-quality data platform for respiratory diseases, standalone technical services can no longer meet practical needs.

To this end, MedCafe has developed a comprehensive solution covering the entire lifecycle of clinical research, which has been validated and refined through its application in specialized chronic obstructive pulmonary disease (COPD) projects.

First is the O2O scientific research training. Leveraging its strong foundation in scientific education, MedCoffee has conducted 19 offline training sessions focused on chronic obstructive pulmonary disease (COPD) over the past year, averaging one research training session every two to three weeks. Meanwhile, a dedicated training platform has been launched on the MedCoffee website, allowing primary care physicians to study research protocols and key points of data collection via the web or mobile app, thereby laying a solid foundation for high-quality scientific data collection.

In clinical research, physicians as variables are relatively controllable; however, data are dispersed across every stage of the clinical process, making it impossible to ensure quality solely through increased manpower.

To this end, the second step for MedCoffee is to provide data technology services. MedCoffee has established a specialized research collaboration network and data platform for chronic obstructive pulmonary disease (COPD). By designing scientifically sound and standardized data elements, and building an electronic data capture system, it facilitates multi-center collaborative data collection and integration. This approach accumulates high-quality clinical research data, freeing physicians from traditional, inefficient paper-based data collection and management methods.

Zhang Yaowen introduced, “Through the research collaboration network, China-Japan Friendship Hospital, as the central hub, can monitor in real time the progress of each participating center in this registry study and provide immediate assistance to resolve issues, thereby establishing a truly seamless, bidirectional, and mutually empowering collaborative mechanism.”

Even though existing electronic data capture (EDC) systems incorporate data logic validation rules and provide solutions for source data collection in formats such as images and audio, clinical research data still require medical monitoring and verification. To address this issue, MedCoffee has partnered with professional contract research organizations (CROs) to jointly assist physicians in quality control of clinical research data.

From methodology and technology to implementation, MedCafe’s third step fills a critical gap in the clinical research chain by adding academic services for clinical research.

In the COPD-specific project, MedCafe participated in the design and refinement of research protocols, and revised and improved case report forms to encompass various clinical and scientific questions. Meanwhile, its professional data management and statistical analysis team was deeply involved throughout the entire process of data standardization, cleaning, collection, and analysis, thereby fully ensuring the quality of clinical research data.

From achieving breakthroughs at individual points to developing comprehensive solutions that cover the entire clinical trial process, MedSci Club has established an integrated framework encompassing “scientific education, research big data, and research services.” This enables MedSci Club to effectively help researchers improve the efficiency of clinical studies and ensure high-quality data and analytical translation.

In the field of clinical data research, few products are designed with physicians as the primary users; instead, most clinical research products are developed to ensure compliance with clinical trial regulations. Consequently, physicians, who serve as the designers, collectors, and investigators of clinical research data, are unable to play their due pivotal role in this process.

Therefore, a real-world study “data middle platform” that centers on physicians as core users, governs data from the source, and is oriented toward clinical research scenarios has emerged as an effective solution.MedCafe integrates extensive medical scenarios with the generation of research data through a highly specialized, vertically integrated approach, establishing a full-lifecycle clinical research platform to collect, integrate, and manage high-quality real-world data. More importantly, the high-level medical evidence generated within this sustainable data cycle is closely aligned with clinical diagnosis and treatment, truly enabling the improvement of clinical practice through clinical research.

“We have chosen to serve the entire lifecycle of clinical research to better ensure accountability for its quality. Omitting any single phase could compromise the integrity of the study. Our strong medical and technical teams provide professional support to physicians from the clinical design stage through to final data analysis, which constitutes our core competitive advantage,” stated Zhang Yaowen.

“When we have successfully established this pathway for the respiratory specialty, we will also be fully confident in delivering better services to other specialties,” stated Zhang Yaowen. “The construction of a clinical research data middle platform requires the joint participation of all sectors in the healthcare industry to improve the data quality of real-world studies, ultimately realizing the promising vision of using scientific research to enhance clinical practice and driving medical innovation through data.”