Updated on 13 January 2015
Global contract research organization, ICON, has been providing outsourced development services including strategic development, management and analysis of clinical trial programs to the pharmaceutical, biotechnology, and medical device industries. Based in Hong Kong, Mr Mei Wing Goh, is the vice-president of ICON in Asia-Pacific region and has over 14 years of experience in the CRO industry. Having worked with global outsourcing firms including Kendle and Quintiles, Mr Goh shares with BioSpectrum Asia the trend of APAC evolving as a preferred site for clinical trial for global companies and how much the region has progressed to tap the surging opportunity.
How do you see Asia evolving as the site for clinical trials? Is the regulatory structure advancing with the onset of clinical trials in the region?
It is recognized that Asia has been rapidly gaining importance in global clinical trials. As 60 percent of the world's population resides in Asia, it offers a tremendous patient pool, which supports patient enrolment strategies that can reduce timelines.
There have also been multiple initiatives introduced by governments, research focused organizations and development societies in the region to help support growth in clinical research. The presence of a well-developed hospital infrastructure and dedicated clinical trial centers in some countries has also supported the growth of welleducated and experienced study workforce.
The regulatory approval has improved drastically in many Asian countries over the last decade. The clinical trial environment has similar characteristics across the region but drug registration requirements and processes differ from country to country. For example it usually takes less than two months to get regulatory approval of a clinical trial in Singapore, Malaysia, Philippines and Indonesia. However, the timeline of regulatory approval in some other countries continue to be a challenge. In China, the average approval timelines can range from 6 to 12 months. China Food and Drug Administration (CFDA) is currently working to improve the application approval process to give higher priority to innovative new drugs and medical devices products. Fortunately, the regulatory delays can be somewhat offset by the availability of treatment-naive populations in these areas.
Also, the government in Korea is reviewing closely the quality of clinical trials. The Ministry of Food and Drug Safety (MFDS), has set up a dedicated team to provide oversight regarding the qualification of sponsors, CROs, institutions, and it has also issued guidelines for the inspection and regulation of all parties involved in clinical trials of new medicines and medical devices. The guidelines aim to protect the rights, safety, and well-being of the patient, to ensure GCP compliance, and to increase the credibility and integrity of the data. The government has also enforced monitoring for post-marketing surveillance studies. The newly-developed regulations and revised guidelines provide stricter control of clinical trials to ensure data quality.
What would be the main factors driving and supporting the clinical research sector in Asia in coming years?
The biggest single driver for conducting trials in Asia is the availability of large numbers of treatment naïve patients-patients that have not previously received treatment for a specific condition. While regulatory start up times can be challenging for some countries the ability to recruit large numbers of patients once the sites are up and running is a major benefit in terms of meeting the timelines required for the overall regulatory approval of the compound. In essence, start-up times can be longer than in Europe or the US for some of countries in Asia but this additional time is more than made up for by the ability to rapidly recruit patients. This is especially relevant for studies that have extended treatment periods (e.g. longer term phase III studies) and enables more rapid drug development and registration, which is a major benefit to the pharmaceutical industry and of course to patients. There are lot of innovations in the medical devices segment. Even integration of pharmaceutical product and medical device is welcomed as an effective approach.