Trending Toward a Global Clinical Development Future
In the past, global drug and medical device approval lag stemmed from complications in international development. Fundamentally, the Asian medical community felt that Asians required lower doses than were tested and approved in the West. Consequently, the same drugs were being developed separately, in Japan and other Asian countries. Furthermore, language complications, differences in facilities, higher costs, and a lack of specialists all contributed to extraneous regional development processes. These complications often led to hang-ups in the approval process, raising development costs and extending timelines.
The problem was most evident in Japan, peaking in 2007 when lag times were averaging 3.4 years, which sometimes prevented products from ever reaching the market. Higher development costs led to a promotion of cheaper, lower-risk drugs that would garner easier approval. Overall, the drug lag led to complications for developers and consumers alike, with safe, effective treatments being kept off the market based almost entirely on logistical complications.
Seeking a Resolution
In 1998, well before the drug lag peaked, the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) was aware that regional development problems were not being addressed, and could foresee increased delays if solutions were not immediately pursued. Their solution: Ethnic Bridging.
Rather than conducting a full series of trials in each region to account for regional differences, the ICH Guidance provided for “Bridging” in circumstances where a medication had been fully developed in one region of the world and was seeking approval in a region where development had not been undertaken or was incomplete. The Ethnic Bridging studies that WCCT conducts are in support of launching Global Phase II/III clinical development programs in countries such as Japan.
The Impact of Ethnic Bridging
The concept of Global Drug Development has paved the way for timely access to needed medications. While some Sponsors have elected to retain existing strategies, WCCT has embraced the trend toward global clinical development, updating our Phase 1 Unit capabilities to more easily implement Ethnic Bridging trials. Since 2004, WCCT has conducted over 185 Ethnic Bridging trials, and has conducted the largest Ethnic Bridging trial ever recorded. As a result, partners have been able to expedite global development, reduce costs, and present effective treatments to the FDA and PMDA in a timeframe concurrent with technological advancements in the industry.
As Ethnic Bridging continues to develop into a mainstream strategy, we anticipate the overall trend toward global clinical development to continue. With anticipated increases in treatment technologies, humanity is best served with development plans that bring effective treatments to market as quickly as possible while still addressing all safety and efficacy concerns. With over 15 years of current experience conducting Ethnic Bridging trials, WCCT looks forward to being at the forefront of the trend toward more effective global clinical development, adapting as necessary to promote global health.
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