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International Clinical Trials

eClinical Solutions in China

Bruce D Schatzman of StudyManager, Inc considers attitudes towards EDC in China, and explains why its uptake has not been as fast as one might expect

Depending on who you talk to, there are different perspectives about the pace of adoption of eClinical solutions such as electronic data capture (EDC) and clinical trial management systems (CTMS). Some people leave you with the impression that EDC is the only ‘real’ choice and that anyone using paper for data capture probably washes their clothes in the river as well. It is true that some biopharma organisations have gone ‘all electronic all the time,’ and that is great. The more the merrier. But eClinical adoption outside the US or Europe is a different story. China is a good example.

We’ve all followed the news about how China is the up-andcoming mega-power, willing to compete in any arena. There is no doubt that China is a rising star in many ways, with pharmaceuticals no exception. China is no longer content solely to provide populations of research subjects for studies sponsored by US and European biopharma. The country has been rapidly building its own pharmaceutical industry with world class scientists inventing novel medications and medical devices that will ultimately be for sale not only inside China but to the rest of the world.

However, visions of China overtaking the US or the EU in pharmaceuticals are premature, to say the least. The Chinese biopharma industry is still relatively new, and so is its adoption of eClinical solutions. On the other hand, the concept of EDC is not new, and EDC has been used extensively in China for years. However, the vast percentage of EDC deployments in China originate with US or EU drug and device makers who need to conduct post-market studies in China in order to gain State Food and Drug Administration (SFDA) approval to sell their drugs to the Chinese people.

EDC ADOPTION IN CHINA

Despite the fact that EDC has been used extensively in China by US and EU companies, when given an option to deploy their own solutions, Chinese CROs and biopharma organisations do not elect to use EDC nearly as frequently as you might think.

There is no doubt that China understands the concept of eClinical and why it is a quantum leap beyond paper. But the landscape in China is different to the US or EU, and this creates some unexpected barriers to eClinical adoption. One of the most important barriers is the Chinese labour market. There are a very large number of educated, hard-working, detail-oriented people available to work within the pharmaceutical industry in China. Not only is there no shortage of entry-level talent, but the average Chinese pharmaceutical industry employee is paid less than half that of the average US or EU employee. As a result, a rich supply of skilled people are available to complete, review and double-data-enter paper case report forms (CRFs) at a relatively low cost. Although EDC delivers on its promise to cut study timelines no matter what country uses it, the overall cost saving of EDC over paper is more modest in China given the high price tags of the larger eClinical vendors.

Without listing them all here, there are many ways to save money by using EDC. It requires far fewer hours of labour by reducing the number of cycles between coordinators and monitors to resolve queries. But just as importantly, EDC saves money by enabling data analysis to begin much earlier during a clinical trial, allowing biostatisticians to detect quickly when the data trend is not leading towards the desired clinical endpoint(s). In this case, the trial can be cancelled months in advance of the point where it would normally be aborted in a paper trial, saving millions of dollars. There are additional cost savings that come from not having to print, copy, ship, handle and double-dataenter thousands of CRF pages. And of course, database lock and site closeouts can happen months earlier than when using paper. So it is not all about reducing labour costs. EDC allows manufacturers to bring drugs to market faster, which increases overall return on investment and gets revenue flowing more quickly – an especially crucial consideration for startups.

UNDERSTANDING THE CHINESE MINDSET TOWARDS EDC

But despite all the other benefits, low labour costs versus the high price of eClinical solutions always seems to be on the mind of the Chinese pharmaceutical executive. In fact, to avoid paying the high price associated with eClinical solutions, some Chinese CROs and biopharma companies actually use SAS for both clinical data management (CDM) and statistics. Although it is possible to use SAS to perform rudimentary CDM functions, it is not designed for that purpose.

Successful selling of eClinical solutions in China therefore requires fresh thinking about pricing. This is why the major EDC vendors have yet to establish a firm foothold in China. In many cases, a product license is given away for free to a Chinese CRO, pharmaceutical company or academic medical centre in order to grab market share and generate a press release about how well things are going in China. But that is not a great business model. Lack of sustainable revenue for the vendor means lack of success for the product, which in turn means lack of support for customers. Chinese business managers understand why a winwin vendor-customer relationship is important. Showering them with free software only makes them nervous that it will ultimately fail and leave them stranded.

BARRIERS TO EDC ADOPTION

The question is whether big EDC vendors can succeed in China, given the price barriers. Big EDC vendors bring large overheads with them, which forces high software prices in order to generate minimum acceptable profit margins. On the other hand, smaller vendors can offer software in China for a price that provides a much greater return on investment for companies while still being profitable for the vendor. Big vendors will still be needed, especially for large trials, but smaller vendors are likely to dominate the market for early-phase trials and postmarket trials initiated on Chinese soil.

But price is not the only barrier to eClinical adoption in China. There are other mountains that EDC vendors need to climb. Among these is that Chinese language support within any EDC product is a must. The vast majority of Chinese people working at CROs or biopharma companies are proficient in English and can read it very well, although they are not necessarily conversant. The reading proficiency means that basic application screens within the software do not have to be translated into Chinese. With appropriate application training, native Chinese speakers can navigate English-language software and read English-language documentation without difficulty. But CRFs are a different matter. On eCRFs, medical field labels can be confusing and open to interpretation – in any language. Consider how many questions we get from English-speaking coordinators on English-language eCRFs. Now consider how much worse it might be when a Chinese coordinator reads medical field labels or clinical questions in English.

From a regulatory perspective, interpretation is a bad thing. If a field label is not crystal clear, the entered data could be suspect. You’ll need to prove that Chinese coordinators were not just guessing what a field label in English actually meant. Field labels on eCRFs (including all forms such as AEs, Con Meds, and basic visit forms) must therefore appear on screen in Chinese. Global EDC vendors already understand this and support many different languages on eCRFs. Smaller vendors looking to do business in China do not necessarily have products that support multiple languages, and this is a big problem. Although it is not technically difficult to upgrade an Englishonly EDC package to support Chinese or other languages, the work can be tedious and take months to develop and test.

CLINICAL TRIAL MANAGEMENT SYSTEMS

Although the focus of this article has been on the EDC side of eClinical, CTMS is a consideration as well. Like EDC, CTMS delivers a range of obvious benefits that US and EU companies have embraced for years. It took a decade longer to catch on, but adoption of CTMS solutions is now widespread within the US and EU pharma and device communities. However, given that EDC is still in its infancy among Chinese companies, CTMS is still years away. As in the US and EU markets, EDC will take the lion’s share of attention in China, and CTMS will follow in a few years.

In addition to the price and language barriers, EDC vendors also face serious difficulty marketing and selling in China. Marketing collateral and ‘messaging’ that works in the US or Europe will not necessarily resonate in China or the rest of Asia. The same can be said of sales techniques and communication styles. People of different cultures respond to different things in different ways. This is a challenge for eClinical vendors trying to do business in China. In China, for example, you can launch expensive marketing and sales campaigns, but until an actual person, trusted by your customer, introduces you personally, you may not have much luck. Trust is a universal hurdle for all companies, but it is expressed differently around the world. Personal networking is extremely important in China, and trust is transmitted through personal introductions. This chain of trust moves from one person to another, and vendors must take great care not to disappoint anyone or the entire chain breaks.

CONCLUSION

An eClinical market will eventually blossom in China, but this will take time. Smaller EDC vendors will pave the way, offering capable systems at a price that small-to-medium size CROs and biopharma companies can afford. This will establish the credibility of EDC within China and prove its value by delivering high return on investment, even in the face of low labour costs. As the Chinese pharmaceutical industry grows, budgets will increase as Chinese drugs and devices make their way into late-stage trials. Labour costs in China will eventually increase as well, and bigger eClinical vendors will occupy the same role in that ecosystem that they currently enjoy in the US and EU communities. But until then, the smaller, faster and less expensive eClinical vendors will receive most of the attention.


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Bruce Schatzman is President of StudyManager, having founded the company in 1993 with the launch of StudyManager version 1. He has spent 20 years in technical and business positions within companies including Microsoft Corporation, Xerox and Tektronix. Bruce received his degree in Applied Mathematics from the University of California at Berkeley.
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