Expanding Data Management Services in China

EDC has become the data management platform of choice around the world, offering advantages such as increasing the quality and timely collection of data. Medrio, an EDC company that offers eClinical software solutions, has quoted that 70% of clinical trials are using EDC as a forms of collecting data in the United States. In China, we have seen adoption rates for EDC increase dramatically in recent years, fuelled by improved technology developments in mobile applications, and the increasing experience with EDC usage in clinical research. 

It is widely accepted that the introduction of EDC globally has led to greatly improved data collection quality as well as timeliness of activities. Lead time for database set up can be 20% to 35% less than a traditional paper database, data is in the database within days or even minutes of a patient visit, and the number of queries can be reduced by 70% to 80%. However, some sponsors still view EDC as an expensive solution because they view the licensing costs of the software without considering the efficiencies in process across broader trial activities. There have been a number of published estimates that show EDC to be a more cost efficient method, effecting cost reductions from 20% to even 50% to 60% when efficiencies are taken into account. Importantly, EDC also enables targeted monitoring and the ability to analyze data quicker, which are invaluable. 

The use of EDC in China remains a mixed story. China is still a relatively new environment for studies and a preference for paper data collection persists in some areas. Generally, international pharmaceuticals conducting trials in Chinese sites will use EDC, as the technology already exists at the core of their data collection, and the experience is readily available within the organization. However, familiarity with EDC at the sites is rising as the number of regional and global studies in China--typically sponsored by international organizations-increases. But many domestic Chinese pharmaceuticals still prefer the paper method, as the experience of using electronic data capture is still limited. In contrast, we have seen startup/biotech companies pursue this new technology more willingly, likely because their core competition is high technology.

There are several reasons why EDC is not as prevalent in China as other parts of the world. Investment in implementing new software, language limitations of software, and technology limitations/connectivity at sites are still real hurdles. Specifically, those connectivity issues exist particularly in the lower grade hospitals and community health centers. However, at major research hospitals, connectivity limitations no longer exist. In these centers, we have found little or no difference in training required compared to Western sites.

As EDC technology has been driven from US and Europe, it initially did not cater for the use of Chinese language. However, as China emerged as a major contributor to clinical trials, software was developed to meet the requirements of Chinese sites. Local language availability was a broader issue, not one just limited to China, but over recent years we have seen translation tools developed that allow eCRFs switch text to a variety of languages. Whether this be Spanish, German or indeed Mandarin, this has vastly increased the number of sites that are able to participate in EDC trials.

As China is adjusting to this new technology, there is a heavy focus on training depending on the experience of sites. Training will be focused on the usage, as it is imperative that Investigators be familiar with the change to dataflow. Furthermore, once the data has been collected, we can identify any further need for training as there will be immediate signs of errors such as incorrect or missing data, and direct monitor resources as appropriate. Monitors must also be familiar with the EDC system and any new programs that are introduced, as they conduct the training on the new sites and investigators. Training includes guiding investigators through a series of screens, inputting the data into the system and how to access different information on the subject.

The variety of EDC providers also means there is great competition in the field, and hence a range of tools with broadening functionality are ever emerging. These software now allow data from different sources, or for different tasks, to be centrally held, with pre-defined integrations. For example, randomization modules (IWRS) can sit alongside drug supply management tool, endpoint adjudication hinges upon robust data being accessible remotely in a timely manner, electronic Patient Reported Outcomes (ePRO) are increasingly being utilized, risk based monitoring relies on near real time data for success, and lab data is now routinely sent electronically from a central laboratory. And yet, despite the increasing functionality, we also see a variety of competitive licensing options being offered. Robust EDC solutions have become accessible to smaller budgets and even with investigator initiated studies.

The increasing exposure to EDC technology will increase the number of sites who are able to participate in regional and global trials, and in a cyclical effect, dramatically increase in the number of such trials conducted in China. This rising familiarity and experience, not just at site level but across service providers and sponsors, is essential in a clinical trial environment that is fast becoming electronic. There is no doubt that China will be part of this shift, and it is imperative that highly experienced resources are available in country to support it.

Paul Donnelly is Associate Director, Data Management and Project Systems at George Clinical, an Asia Pacific CRO headquartered in Sydney, Australia.