Japan Relaxes Clinical Trial Regulations; China Still Strict

Parexel's President & COO Mark Goldberg sat down with Applied Clinical Trials for a quick discussion on the trials market in Asia Pacific.

When you look at trends for where the newest opportunities are for sponsors, our clients, to sell their drugs certainly Asia Pacific is the biggest growth area. There are other emerging regions, certainly, but if you had to pick one, Asia Pacific would be the one you would pick. Not as much India at the moment.

Lots of growth in Japan at the moment, driven by the fact that the government is really trying to address their historical drug lag. Approvals are happening sooner and there is more flexibility about the inclusion of data from other Asian populations. Japan is a little more relaxed now in terms of trial participants, not to the point that they would be willing to look at Western data but certainly from different Asian countries.

In China you have a lot of demand for clinical trials. You have a reshuffling of the regulatory authority, which is creating some delays in getting trials started. Right now it is taking between 12 and 24 months to get new trials started in China. It depends to what degree the indication is viewed as a priority by the Chinese government for their population.

In the case of biologics, all phases of development, Phase I through Phase III, have to be done in China. This is relatively new requirement in the biologic space. For other indications that is not the case and you can include a sub-population in China within a larger global study. You have to agree with the Chinese authorities about how many patients from China would be required to meet their needs for local registration.

Another aspect that makes conducting trials in China a little more difficult is the fact that to be an investigator you have to be certified by the government. There are still a relatively limited number of certified investigators. I think China is picking and choosing a little bit on what their priorities are.