Emerging markets, such as the Asia-Pacific region, have garnered a lot of attention over the last few years, notably for its vast potential in resources, patient access and infrastructure. Nevertheless, against that backdrop, companies who venture east find themselves faced with a deluge of issues having to navigate stringent regulatory barriers that can often derail a trial before it even gets started.
Tom Guntly is the director of Clinical Development at FibroGen. Having extensive experience in overseeing trials conducted in China, Guntly understands firsthand the ups and downs of conducting studies in the Asia-Pacific region. Below he sits down with CTA Editor Henry Kerali to share his experiences and offers advice to fellow to professionals looking to journey east...
Henry Kerali: Explain the landscape of clinical trials in China. What are some of the challenges you’ve come across?
Tom Guntly: First and foremost, China’s role in clinical R&D is growing, so it’s important that companies, large and small, understand that if they enter the region they need to be ready for a lot complexities and they have to be prepared for the time that it will take for certain activities. You also need to be aware of the culture and how they run clinical trials.
HK: To that end, what are some of the complexities companies face when conducting trials in China?
TG: The regulatory pathway can be complex depending on whether you’re applying for an imported drug registration or developing it through a domestic trial application. Therefore you have to be very familiar with that process either as a multinational pharma company or with an outsourcing partner who’s very familiar with China drug development. The start-up activities and CTA approval will take time, but development activities can be expeditious.
HK: What’s the patient population like in China – is it fair to say it’s large?
TG: Yes, there are 1.5 billion people in China and so there’s a large patient pool that’s available and incredibly eager to do research. Their access to treatment and to drugs is limited, and the personal health insurance compared to the western world is inconsistent. Furthermore, it’s also a treatment naïve population. When you consider there are 318 million people in the U.S., it’s very competitive and there are assorted limitations in terms of certain disease states that you can study. Nevertheless, in China, what you have is a good environment for developing drugs, and bringing treatments to a wide range of people.
HK: What are some of the disadvantages in going to China? You alluded briefly to the regulatory barriers that companies could face, but what else do sponsors need to be aware of?
TG: Time, for one. And it can be costly. If you’re a domestic company developing a drug there, you’re already entrenched in that environment and have fully committed to marketing your drug in China. Efficiencies of a domestic company can be realized. If you're a multinational company coming into China, it's fairly straightforward and there’s a high probability of success, but time and cost are obviously factors.
HK: When you’re running a trial in China, how can you oversee a site and make sure site staff are conducting the study correctly?
TG: You need to have a good partnership with a CRO in China. It’s imperative to have a vendor that not only knows China, but is familiar with the regulations. Additionally, most sites need a clinical research coordinator (CRC) to help run the trial, in terms of regulatory submissions, EDC and so forth, so you are providing a resource to them. Even though this is a necessity, I find it a huge benefit to the sponsor because, one, you’re helping the site do what you want them to do for you, and two, the CRC provide oversight and management directly at the site level for a sponsor who is displaced from the site. This is important.
HK: How do you engage with a site, do you adopt a hands-on approach, or do you hand full control over to a CRC as you mentioned?
TG: Every trial has different requirements in terms of outsourcing needs and ownership. I’ve worked for large pharma companies in the past where they have engaged the CRO to handle all the business. On this occasion, I would go out and conduct surveillance co-monitoring with some of these CRO partnerships. I was amazed when an investigator would be surprised to see a sponsor at the site because they were only engaging with the outsourcing partner once the investigator meeting was concluded.
At my current organization, when we send out contracted regional monitors, which enables us to be involved in the trial at an intimate level. We feel the need to be true sponsor ambassadors to the study and introduce those contract regionals as our own company members even though they’re under contract. In China, relationships are genuine and are very, very important, and we routinely have our management staff visit our investigative sites to not only show our support, but to listen. We respect this relationship.
HK: Is it important that sponsors partner with vendors that have localized knowledge of China?
TG: Absolutely. Sponsors may have subsidiaries entrenched in various countries around the world, but employing localized vendors that are China-based professionals who know the laws and procedures is key. It’s important to employ Chinese-based organizations because they have special knowledge of China, a strong local team, as well as experience dealing with regulatory bodies. Therefore, it's important to work with the system and the professional that they have. You will need strong vendor management once you do that, for sure.
Overall, we know that China is an emerging country with a lot of development growth to be tapped. In terms of development, the pharma industry has made modest strides compared to the country’s size, but you can see the continuing grow this there. The Chinese government is making every effort to streamline processes. When I talk about time due to regulatory requirements, you may need to slow down a little bit during the application process first in order to pick up speed in your development phase. Right now a lot of the evolution and changes are going on in the country, so if someone is planning on going into China within the next decade or so, they'll see enhanced efficiencies in how they run trials there in terms of time, quality and access.