Japan to be hot destination for trials in 2015 say experts, despite drop in MRCTs last year

By Gareth Macdonald

- Last updated on GMT

Tokyo, Japan - will see more multiregional trials in 2015 says Tufts and PPD
Tokyo, Japan - will see more multiregional trials in 2015 says Tufts and PPD
Japan was involved in fewer drug industry-sponsored multi-regional clinical trials (MRCT) in 2014 than any year since 2008 according to the Pharmaceuticals and Medical Devices Agency (PDMA).

The Tokyo regulator told Outsourcing-pharma.com that, to the end of October, 110 MRCT had been registered in Japan, which is down from the 169 drug industry-sponsored research programmes filed in 2013.

The 2014 figure is the lowest since 2008 when, according to the PDMA, 82 MRCTs were registered with Japanese authorities.

MRCTs came to prominence in Japan in 2006 when the International Conference on Harmonisation (ICH)​ suggested they could be used to conduct bridging studies required by the country’s regulators at the same time as the wider research programme.

Before 2006, bridging studies – which are used to assess if findings from foreign trials are applicable to Japanese patients – were often conducted after the study programme was completed, lengthening approval timelines.

After the ICH document the number of MRCTs including a Japanese site trended upwards, apart from in 2011.

2012 saw a 30% leap in the number of MRCT’s including a Japanese site after the PDMA introduced greater flexibility regards IRBs in good clinical practices (GCP) guidelines, which made the country more attractive.

Insiders confident of growth

Whether the drop in MRCTs involving a Japanese site was because fewer multiregional trials were conducted global in 2014 is hard to assess – differing regional registration requirements mean accurate data on the number of studies registered is not readily available.

However, observers we asked were confident the decline does not indicate drugmakers are losing interest in conducting research in Japan.

Kenneth Getz, Director of Sponsored Programs at the Tufts Centre for the study of drug development, told Outsourcing-pharma.com that: “Tufts CSDD recently conducted an analysis of new clinical trial starts in Japan relative to other parts of the world.  Our research indicates that Japan is the fastest growing region at this time though growth is based on a historically low number of active trials there.​ 

Regrettably, we don’t have a good understanding of why this [the rapid growth] is the case.  We believe it may be due to a number of factors including growing regulatory agency and health authority receptivity to conducting trials in Japan​.”

This echoed what US contract research organisation (CRO) Pharmaceutical Product Development (PPD) said this week during a discussion of its partnership with Tokyo-headquartered contractor SNBL.

PPD spokesman Randy Buckwalter told us “pharma companies are now accelerating the inclusion of Japan in global drug development programs concurrently with development in the US and Europe markets.

The inclusion of Japan in global trials has resulted in sponsors attempting to consolidate Japan development with global CRO partners in order to gain efficiencies. As a result, Japan capabilities have become a major factor in the selection of CROs during global strategic partnership decisions​.”   

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