FDA Finalizes Guidance on EHR Data Use in Clinical Trials, Emphasizing EDC Interoperability

As the world’s most closely watched drug regulatory agency, the U.S. FDA has been leading the development of pharmaceutical regulations. Recently, the FDA released the Guidance on the Use of Electronic Health Data in Clinical Trials. VCBeat (WeChat ID: vcbeat) obtained the guidance and provided a full translation.

We found that the most significant recommendation in the Guidelines is to promote the integration of Electronic Health Record (EHR) data into Electronic Data Capture (EDC) systems for clinical trials. In light of this, we interviewed Ding Lihua, COO of LinkDoc Technology, and Ma Dong, Vice President of the Clinical Research Division at Taimei Medical Technology. They discussed the importance of applying EDC systems and EHRs in clinical research as outlined in the Guidelines, as well as the impact of these guidelines on the future development of the industry, particularly on the nascent domestic sector in China.

The FDA’s issuance of this guidance marks a step in its clinical trial reforms. Previously, FDA Commissioner Scott Gottlieb noted in a statement that current restrictions on clinical trials were hindering the speed of new drug approvals. The FDA is adopting more modern and scientifically rigorous methods to evaluate clinical data collection in new drug development, including the use of mobile devices and the assessment of clinical data as part of the drug development process.

The issuance of this guideline also fulfills an uncompleted objective of the 21st Century Cures Act signed by President Obama. The Act mandates that the FDA achieve certain deliverables in the use of real-world data, including establishing a framework for programs evaluating real-world evidence and issuing guidance to industry on the use of real-world data in regulatory decision-making.

VCBeat found that the three key components in the FDA guidance are:

1. Clarify the scope of data from EHR systems that can be collected into EDC systems during new drug development;

2. Guidelines for the Integration and Compatibility of EDC and EHR Systems;

3. FDA-Recommended Standards for EHR Systems.

In this guidance, the FDA emphasizes that EHR systems and EDC systems are applicable only to the prospective development of drugs, biologics, medical devices, and other combination products. They also apply to foreign clinical studies conducted under FDA oversight in accordance with relevant regulations, but not submitted to the FDA under an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).

In this guideline, the FDA specifically highlights recommended EHR systems. The FDA recommends using EHR systems certified by the Office of the National Coordinator for Health Information Technology (ONC). Established in 2004 and headquartered in Washington, D.C., ONC is the primary federal agency responsible for coordinating nationwide resources and advancing health information technology and electronic health information exchange.

In its guidance, the FDA recognizes significant advantages in using ONC-certified systems. ONC-certified EHR systems ensure interoperability and stability, while also safeguarding the confidentiality and security of electronic data as well as user privacy.

In its guidance and related statements, the FDA recommends the use of EHR data in EDC systems to enable broader utilization of clinical data, maximize its medical value, and support the development and application of safe and effective drugs.

Electronic Health Records (EHRs) enable clinical researchers to access a wide variety of data types, such as clinical records, physician orders, medical imaging, laboratory data, and medication records. These data can be integrated, aggregated, and analyzed. EHRs allow clinical researchers to obtain real-time data for review and facilitate post-clinical follow-up with patients to assess the long-term safety and effectiveness of medical products. Furthermore, they offer the opportunity to conduct long-term follow-up on large patient populations, which may be particularly important for studies where outcomes of interest are rare, such as prevention studies.

Data elements derived from Electronic Health Records (EHRs), such as demographic data, vital signs, laboratory results, and medications, can automatically populate electronic Case Report Forms (eCRFs) within Electronic Data Capture (EDC) systems. Furthermore, interoperable EHR and EDC systems can provide access to information generated by other clinical information systems, such as Radiology Information Systems (RIS) and Laboratory Information Systems (LIS). Interoperable systems streamline data collection in clinical research, enabling clinical researchers to access source data during patient visits. Additionally, interoperability reduces errors associated with manual data transcription, thereby enhancing data accuracy and improving the quality and efficiency of clinical trial data.

In the field of new drug development, the domestic and international markets are inextricably linked. The primary users of Electronic Data Capture (EDC) systems in China remain multinational pharmaceutical companies operating within the country, which possess stronger payment capabilities. Changes in FDA policies will inevitably impact relevant domestic enterprises as well.

The development of the Electronic Data Capture (EDC) market has been relatively understated, despite its critical role in clinical trials for new drug development. New drug development has consistently accounted for the largest share of investment in the pharmaceutical industry, with an average timeline exceeding ten years. The adoption of EDC systems by pharmaceutical companies or Contract Research Organizations (CROs) not only reduces costs but also serves the primary and direct purpose of ensuring the quality of clinical research data, regulatory compliance, and overall study integrity.

Regarding the FDA’s guidance, both Ding Lihua, COO of LinkDoc Technology, and Ma Dong, Vice President of the Clinical Research Division at Taimei Medical Technology, noted that while the FDA appears to be promoting interoperability between EHR and EDC systems, its fundamental objective is to advance the standardization and structuring of medical data.

Ding Lihua stated that the more pressing issue in China remains the standardization and structuring of clinical data. The interoperability between EHR and EDC systems proposed by the FDA this time implies that achieving true informatization of clinical trials requires enhancing not only the capabilities of EDC systems but, more importantly, the overall normalization and standardization of clinical data.

Ma Dong also stated, “The utilization of EHR data has long been a focal point of global attention, with countless individuals hoping to extract greater value from this seemingly natural large-scale database. However, from the perspectives of data and technology, we need to address the following issues in order from basic to advanced: 1. Establishing unified data standards; 2. Data structuring; 3. Data mining; 4. Value feedback. The FDA’s recent actions clearly aim to introduce standards and promote structuring, which aligns with the approach the United States has consistently adopted. Although this statement explicitly excludes applications in areas such as pharmacoepidemiology and patient recruitment for research, it undoubtedly lays the groundwork for the future implementation of these studies across the industry and establishes a foundation for the broader utilization of health data in diverse scenarios.”

In addition to promoting data standardization and structuring, FDA guidance will also advance the application of clinical data, thereby creating more opportunities for new drug development. As noted in the FDA guidance, interoperability between Electronic Health Record (EHR) systems and Electronic Data Capture (EDC) systems can facilitate preventive research.

Ma Dong further explained, “Electronic Health Records (EHRs) also offer the opportunity to conduct long-term follow-up on large patient cohorts, which is particularly important for studies where outcomes of interest are rare, such as prevention studies. In this context, we recognize that the defining characteristics of prevention studies are large patient populations and long-term follow-up. Currently, large-scale studies still rely on manual execution, leading to prohibitively high data collection costs; it is not uncommon for research expenses to exceed hundreds of millions of yuan. The inability to conduct extensive long-term follow-up results in poor data quality, which in turn prevents the emergence of statistically significant findings of interest. To summarize: high costs, poor outcomes, and extremely low cost-effectiveness.”

EHRs have transformed the fragmented distribution of information, enabling easy access to and sharing of patient data. Ma Dong also believes that EHRs serve as natural collectors of patient health data, allowing for the acquisition of the most authentic and comprehensive data at minimal cost. This effectively improves data quality, thereby reducing sample size requirements and increasing the likelihood of revealing accurate and meaningful results. As a result, the cost-effectiveness of prevention research is significantly enhanced, generating greater interest among more research institutions and enterprises and driving its development.

According to data from a report by the forecasting firm Stratistics MRC, the electronic data capture (EDC) system market is projected to reach a value of $1.16 billion by 2025. Abroad, the EDC adoption rate stands at approximately 90%, whereas in China, this figure is only 30%–40%. Overseas market players include top-tier software company Oracle, as well as Medrio, a startup leveraging blockchain technology to digitize clinical trial information.

Ma Dong believes that although the adoption rate of Electronic Data Capture (EDC) systems in China is relatively low, it is rising rapidly. He attributed the previously low penetration rate to five factors: “1. While the industry’s understanding of clinical research data quality management has improved significantly, it remains insufficient; 2. Compared with the implementation of international data management guidelines and CDISC standards, China is still in the early stages of promoting such guidelines and standards; 3. There is a lack of awareness and understanding of EDC systems within the industry; 4. Some enterprises exhibit resistance to and concerns about informatization; 5. There is a shortage of professionals specializing in data management.”

The rapid increase in domestic adoption rates and the expansion of industry awareness are inseparable from the continuous advancement of clinical research informatics systems in China.

Ma Dong stated that the development of Electronic Data Capture (EDC) systems has far surpassed simple electronic data collection. Taimei Medical’s current EDC system not only standardizes data structures but also expands from electronic data capture and management functions to incorporate artificial intelligence and big data analytics, aiming to eliminate traditional control groups in clinical studies by leveraging historical EDC data. Furthermore, Taimei Medical is implementing a strategic transition toward becoming a research collaboration platform.

Furthermore, EDC is evolving from a standalone project-level tool into a clinical research data management platform. By establishing platform-level metadata and CRF libraries and integrating third-party data sources, it provides enterprises with a more accurate and efficient approach to rapidly building project databases and streamlining data collection and management processes.

China is catching up in terms of data standardization and structuring. Ding Lihua disclosed to VCBeat that after merging with an EDC company last year, LinkDoc has developed its own technical capabilities for EDC systems in accordance with international standards. LinkDoc standardizes and structures hospital data, transforming large volumes of clinical data into application-level data. As a leading enterprise deeply engaged in medical big data, LinkDoc has accumulated nearly 3 million structured medical records. The company also aims to expand the scale of its data resources and promote broader application scenarios for clinical data. For instance, real-world studies based on extensive real-world clinical data can help evaluate the clinical application of drugs, thereby extending drug life cycles and enhancing their commercial value.

It is foreseeable that factors such as improvements in information management and analysis, expansion of product lines, advancements in technology and scientific data, increased outsourcing by pharmaceutical and biotechnology companies, and growing demand for EDC services are all driving the growth of the EDC market. Manufacturers are increasingly adopting cloud-based services and implementing fully integrated solutions, which will create profitable opportunities for growth in the EDC market.

According to an analysis in a report by the forecasting firm Stratistics MRC, the booming CRO market has also driven growth among EDC providers that offer informatics solutions for pharmaceutical R&D. The use of EDC in clinical trials can improve data management quality and reduce costs; therefore, web-based delivery models are expected to capture the largest market share. During the development phase, Phase I is projected to grow at a significant rate, driven by direct data and remote information access, as well as increased spending on new drug development.

CROs are expected to constitute the largest market for EDC, as most of them utilize commercially developed enterprise applications to support Phase II and Phase III clinical development. EDC vendors typically serve both domestic and international pharmaceutical companies. In terms of market volume in China, domestic pharmaceutical companies account for the majority. However, given the stronger payment capacity of international pharmaceutical companies, the business revenue derived from both segments is roughly balanced.

CROs and EDC vendors are not, strictly speaking, in a client–vendor relationship; rather, they are partners, as the ultimate payer is the study sponsor, i.e., pharmaceutical companies. North America is the dominant market for major pharmaceutical companies. The Asia-Pacific region is expected to become the fastest-growing market, as many pharmaceutical companies are adopting eClinical solutions.

Jacqueline Corrigan-Curay, J.D., M.D., Director of the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research, commented on the FDA guidance: “As our understanding of new medical products continues to grow, so does our knowledge of how to maximize their benefits and minimize potential risks, driven by the accumulation of data. Clinical use of each product generates data that help us better understand its safety and effectiveness. This guidance facilitates the use of electronic health record (EHR) data in clinical investigations and supports the integration of data collected during routine care into clinical trials. Leveraging real-world data from EHRs enables clinical investigations to generate appropriate scientific evidence from routine healthcare practice and regulatory decision-making, thereby helping to produce accurate, science-based information that healthcare professionals and patients need to use medical products to maintain and improve public health.”

VCBeat has found that the latest domestic policy on EDC is the "Technical Guidelines for Electronic Data Capture (EDC) in Clinical Trials" issued by the CFDA in July 2016, which encourages the adoption of EDC systems and also specifies standards and requirements for EDC functionality. Through interviews, VCBeat has discovered that with industry development, there is a growing need for regulatory authorities in China to introduce standardized policies.

Regarding the internal factors driving the development of normative policies, Ding Lihua stated that leading enterprises such as LinkCare Technology leverage their accumulated industry experience and standardized data within their development strategies to promote corresponding policy changes, thereby collaborating with policymakers to enhance the broader healthcare industry.

From an external perspective, Ma Dong, Vice President of the Clinical Research Division at Taimei Medical Technology, stated to VCBeat: “China’s pharmaceutical industry is moving toward internationalization. Particularly since joining the ICH, data standards and data management models are inevitably aligning with international norms to ensure that data generated in China is authentic, credible, and acceptable to other regulatory authorities. Therefore, domestic policies will increasingly encourage, standardize, and strictly regulate the use of EDC systems, which will inevitably further promote the development of EDC and raise entry barriers.”

As a systematic tool, Electronic Data Capture (EDC) helps ensure data quality in clinical research and accelerates the market launch of new drugs. Meanwhile, data resource sharing and multi-party collaboration represent breakthrough points in the second revolution of R&D execution. The development of EDC and Electronic Health Records (EHRs) will undoubtedly streamline processes, significantly reduce costs, and greatly improve data quality and overall outcomes. FDA guidelines have promoted the informatization of clinical research from a policy perspective, guiding industry development. It has been two years since the introduction of relevant policies in China. With the acceleration of healthcare reform and the growing demand for medical informatization in China, domestic policies are expected to become clearer and more defined. Consequently, the nascent EDC market in China is poised for significant expansion.