Inclusion in clinical studies: PPD talks 'ethno-bridging'
The challenge for drug developers looking to provide their products to the Asian market begins with the fact that people of Asian ethnicity tend to metabolize pharmaceutical products differently than other ethnicities, according to PPD.
Specifically in Japan, regulatory authorities require sponsors to provide Japanese-oriented pharmacokinetic (PK) data prior to Phase II efficacy studies conducted in Japan or a Phase III global trial.
Through its 'ethno-bridging' offering, PPD enables developers to include Asian populations in their clinical trials conducted in the US or Western Europe, in order to test for potential intrinsic/extrinsic ethnic differences and prepare the required PK data.
Outsourcing-Pharma.com spoke with Darin Brimhall, the medical director of PPD early development’s Clinical Research Unit in Las Vegas, US, about ethno-bridging and how it can assist in the drug development process.
“During the past few years, the Asian markets are leading sales growth in global pharmaceuticals, and industry focus is shifting from North America and Europe to Asia,” Brimhall noted; however, adding that “for many global companies, the first filing with regulators occurs in the US or Europe, and that can result in a loss of revenues in Japan.”
By including Asian patients in early clinical studies outside of Asia, “The Phase I process can be completed more quickly, and costs can be reduced,” the executive noted.
Instead, “ethno-bridging allows developers to prevent unnecessary duplication of clinical trials, minimize costs and solve the drug lag issue simultaneously,” as well as to “fully and separately develop new medicines for each geographic market,” if the opportunity appears.
“Quicker development time leads to increased valuation of the sponsors’ assets, while it also increases the ability to achieve commercial milestones earlier,” Brimhall told us.
Brimhall explained to us the criteria to select Japanese patients as participants in clinical trials conducted in the US. These include that the patient must be a native Japanese, and living in the US for less than 10 years.
The criteria set by Japanese regulators also include that the lifestyle and diet, as well as other health-related factors, must not have changed significantly since relocation, and that the patient lives in high-density Japanese locations, in order to ensure that they maintain a 'native routine'.
Moreover, the conditions during the ethno-bridging study must be strictly controlled as well, Brimhall noted, and that is why the company’s services look to maintain a Japanese environment, in multiple ways.
According to the executive, patients in the trial are provided with ‘authentic’ Japanese meals to maintain their diet, as well as ‘culturally-appropriate’ entertainment, including Japanese books, magazines, newspapers, comic books, news and TV shows.
Finally, during the studies, patients are located in a unit with other Japanese patients, as well as being looked after by Japanese physicians and healthcare providers.