Outsourcing
When choosing and working with a partner for a central lab, there are a number of factors to consider, such as cultural differences.
Sponsors should be alert to the differences between the countries in the region, says Bi. He points out that Labcorp has only one central lab in the US and one in Europe, but has three in Asia- Pacific (in Singapore, China and Japan). “China has very strict import/export rules on biological sample shipments, so it’s not that easy to go in and out, whereas Singapore is an open port, so you can easily do this without any time delay,” he explains. Anything imported into or exported from China requires an extra few days. “You also need to submit for approval, probably a few weeks or months in advance,” he adds. That would make it extremely logistically difficult if the trial was being run in China, but the laboratory was based in Singapore.
“You need the ability to get to the right people, have the right conversation and do this in a manner in which you can affect the change that you’re looking for. Managing central labs at distance is not just a physical distance, it’s also a cultural distance, so you can’t just mail it in.”
Michael W Young
Regulatory processes are very different in many of the Asia-Pacific countries, so it’s worth choosing a central laboratory partner who is experienced at managing the regulatory approval process. “The biggest thing when you’re doing drug development is time, time, time,” says Bi. Time can be saved by launching processes in parallel. Even when steps cannot be carried out in parallel, they can usually be performed in a staggered way to reduce timelines, he says. Sometimes the clinical trials application or Human Genetic Resources Administration of China
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(HGRAC) application comes back with a request for supplemental information. “Every time you do this, that delays the process,” says Bi. “Our goal with clients is always to accomplish one-time submission and one-time approval, so that also saves a tremendous amount of time.”
A global petri dish Finally, when choosing and working with partners in China or other countries in Asia-Pacific, don’t forget the significance of cultural factors.
Bi says that in the past five years “tremendous progress” has been made in China, but certain nuances still exist. For example, he says, in Western countries, if you need to have, for example, an ethics committee meeting, you will simply call a meeting: “Whereas in China the site will say, ‘We do it only once a month,’ so you need to follow that rule. If they [the meetings] are every first Tuesday of the month, then you just have to prepare everything ready to go on the previous Friday.” It’s helpful to remember, adds Young, that in most Asian cultures a “much higher value” is given to professional hierarchy than in the West. If something goes wrong, he says, “You need the ability to get to the right people, have the right conversation and do this in a manner in which you can affect the change that you’re looking for. Managing central labs at distance is not just a physical distance, it’s also a cultural distance, so you can’t just mail it in.”
Perhaps those cultural differences are less important than they used to be. The pandemic has taught us that we’re a “global petri dish”, says Young, and we need to work together to solve global challenges. Between the “harmonisation and standardisation” that central labs provide and the favourable economics of conducting trials in the Asia-Pacific region, he believes there’s a strong opportunity for clinical development as the number of studies continues to increase. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
ImagingStocker/
Shutterstock.com
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