Graham Bunn at Medidata Solutions Worldwide explores experiences of electronic data capture implementation in Asia Pacific
The Asia Pacific region is becoming increasingly important for biopharmaceutical companies. The emerging markets are demonstrating an increasing need for high quality healthcare, while providing an attractive environment to conduct first-rate clinical trials with rapid access to treatment-naïve patients, excellent investigators and low R&D costs. This shift in the global clinical trial landscape is occurring as the industry rapidly moves from traditional paper-based data management techniques towards more advanced electronic data capture (EDC) and electronic data management (EDM) techniques. This article examines some of the considerations required when conducting EDC/EDM-based trials in the Asia Pacific region, along with the advantages EDC/EDM can bring to these large, remote trials that are often difficult to manage.
The clinical trials market in Asia is continuing to see major, perhaps unprecedented, growth as the balance of the pharmaceutical market continues to swing away from the US and Europe towards the world’s fast developing economies. These are typically defined by a per capita gross national income (GNI) of less than US$20,000 and embody much of the Asia Pacific region. In emerging markets, the availability of healthcare is rapidly expanding, and with it there is an increasing need for treatments for chronic diseases typically associated with developed countries.
The emerging markets currently represent just 17 per cent of the global pharmaceutical market, but in 2007 it is predicted they will contribute 30 per cent of the growth (1). The rising demand for high quality healthcare and the fast growing pharmaceutical market can mean that clinical trials either located fully within the Asia Pacific region, or global trials with sites located within Asia Pacific, are also rapidly on the increase and changing the global clinical trial landscape.
When these business drivers are added to the advantages of conducting clinical trials in Asia Pacific, it’s easy to see why such rapid growth in clinical trials is taking place within this region. Investigators in these areas are frequently more open to new technologies, have fast access to treatment-naïve patients from a culturally diverse population, and because trials in Asia Pacific have reduced R&D costs yet frequently manage accelerated R&D timelines, it’s a win-win situation.
While this change in global trials is taking place, biopharmaceutical companies are rapidly changing the technology used to collect and process clinical data in their drive towards more efficient trials. Paper is being rapidly phased out and EDC is on the way in. As of 2006, an estimated 20 per cent of all study starts now use EDC, and this trend continues to grow at a compound annual growth rate (CAGR) of approximately 30-40 per cent by the end of 2007 (see Figure 1). This is bringing together clinical trials involving both new technology and the Asia Pacific region at an ever increasing rate, so it is important to understand the differences associated with running EDC trials in this region.
Asia Pacific is typically defined in terms of clinical trials space, including countries such as India, Pakistan, China, Indonesia, Singapore, Thailand, Philippines, Taiwan, Japan, Australia and New Zealand amongst others. Indeed, not all of these can be considered as emerging markets, but many of the potential EDC differences are common to all locations.
ASIA PACIFIC CLINICAL TRIALS CONSIDERATIONS AND EDC
There are certainly many differences between running clinical trials in Asia Pacific and the Western world, but many of these (such as those associated with regulatory approval, for example) apply equally to both paper and EDC. This article focuses on major differences that arise when running clinical trials in Asia Pacific where EDC can make a positive impact and improve the situation across the paper world, or where additional attention is required to make sure EDC trials progress normally. Given this mandate, the four most significant differences regarding the conduct of EDC clinical trials in Asia Pacific (in comparison to the US, Canada and Western Europe) can be summed up as language, distance, infrastructure and culture.
