Market Report

Volume 5 Issue 424 Journal for Clinical Studies

Asia nowadays is considered definitively as the fastest-growing market, and a consolidated area for drug development. Asia not only offers the highest number of treatment-naïve patients able to participate in trials, and a steady improvement of regulations, but it also offers the lowest trial cost in the world. As part of this trend, Taiwan has developed and continues to show the world its unique capabilities for clinical trials. Herein, we would like to show the potential and clinical research environment of Taiwan, considering selected critical cross-points while conducting clinical trials.

Study Management & Subject RecruitmentOne can consider that the diversity in languages can

be a burden while conducting trials in Asia. However, communication should not be an issue, considering that most of the management involved in a trial should and can speak professional applied English or Chinese. A good example of this situation is Taiwan, where the majority of medical records, guidelines and daily research interaction is done in English.

Asia is expected to account for 60% of the world’s population by 20501. This huge population presents a distinctive opportunity for recruitment of patients into clinical trials. It is no secret that Asian countries are characterised by their diversity in terms of population segments, disease patterns, literacy rates, and mortality rates, which very often offer a sufficient pool of research subjects. This factor, considered along with the demography, infrastructure upgrading and grade of compliance with research standards, help us to understand why Asian countries are more involved in large-scale and pivotal trials in comparison with past decades. For example, according to the ClinicalTrials.gov website, between April 2008 and March 2011, 33.8% and 17% of all Phase III and II trials respectively were conducted in Asia. All these features make Asian countries, and especially those which have all the above advantages (Taiwan, Korea, China) as potential key centres for conducting clinical trials in Asia.

Regulatory Affairs The environment surrounding the regulation of drugs and

devices in Asian countries has shown steady improvement in recent years.

Figure 1 Timeline for IND and NDA in China, Taiwan and Korea.

Clinical trial facilities in China have been working on streamlining government regulations and becoming aligned with international standards of practice. The Korea FDA (Food and Drug Administration) also revised their KGCP in 2000, separating the IND (Investigational New Drug) process from the combined IND/NDA (New Drug Application) to streamline the IND review system in 2007. The Taiwan health authority (TFDA) has also been reformed to improve the efficiency of the process from policy planning to execution, and to increase administration efficiency. In 2010, TFDA set up fast-track (priority, abbreviated) review processes for IND and NDA. For INDs, the fast-track review process was issued for trials that have the same FDA-approved IND number as in the US, or for multi-national INDs issued by ICH member states. The fast-track review process for NDAs has shortened the review process time by up to two-thirds for studies considered as targeting unmet medical needs and/or with clinical advantages. In addition, for new chemical entities approved by USFDA or EMA, the expected NDA approval time has been reduced to half of the previous review period.

Figure 2 Pharmaceutical Regulations in Taiwan

Clinical Research Environment in Taiwan

Source: CFDA, TFDA, KFDA

websites.

Timeline information in

parenthesis is based on real-time

experience. A+ Inc. files.

Source: TFDA website.

Figure 3 Lower Trial Costs in Asia-Pacific

Source: Optimer Pharmaceuticals, Inc. Economic Cooperation

Framework Agreement: Potential for Taiwan/China Biopharma.

Mar 2011.

Clinical Research Cost The cost for conducting a trial in Asia-Pacific is much

lower than in other regions. Figure 3 shows the average principal investigator’s total cost2. Investigator and site fees are approximately one-half of those in the United States. Cost savings of global clinical trials in Asia could be resulting from the following factors: further costs to the sponsor for providing trial-related medication, investigations, and hospitalisation could be as low as 30% of those in America. Domestic travel costs for monitoring sites are lower because of the concentration of sites in the major cities and comparatively less costly fares and tariffs. Support services, such as printing, translation, and local courier fees are also less expensive3. By means of the high quality clinical research resources and relatively low costs, there are more and more international companies conducting their clinical trials in Asian countries.

Logistics & Supply of Clinical Materials and Sample Management

With the growing complexity of clinical trials, more challenges will need to be overcome in managing the clinical trial material supply chain. Clinical research organisations (CROs) are now been tasked with managing clinical supply chains, which lead to a strategic relationship between CROs

Figure 4 More industries conducting their clinical trials in

Asian countries

and clinical supply chain service providers. Cooperation with a regional CRO can help to set up efficient and applicable supply chains to adapt to potential and current supply challenges.

In conclusion, Asia offers a standard streamlined clinical trial environment which, along with all the cost-effective variables involved, should lead to any serious industry player considering Asia - especially those developed regions such as Japan, Taiwan, Korea, and China - as a natural niche for drug development and marketing expansion.

Market Report

Journal for Clinical Studies 25www.jforcs.com

Penny Chen, PhD in biopharmaceutical science is a medical writer in A+ Inc. A+ Inc. is a unique Asian regional CRO dedicated to assist sponsors worldwide for drug development and marketing. As a part of the PPC Group, A+ Inc. is committed to win recognition as a

sustainable and critical partner of the pharmaceutical industry in Asia. Email: penny.chen@apluscro.com