CLINICAL OPERATIONS AND OUTSOURCING
commercial company is involved. For example, just 1% of single-country trials in China involve anti-inflammatory drugs, compared with 5% of single-country trials in China with a commercial Western sponsor. This is also the case for steroid therapy (0.6% versus 4%) and synthetics (0.5% versus 4%). Multi-country trials in China for haematological disorders and respiratory disease are more likely to include commercial Western sponsors (78% and 66% respectively). But these therapy areas also see above-average Western involvement in multi-country trials in Japan (71% and 58%) and South Korea (72% and 55%).
Trends in China regulatory approvals IQVIA clinical project management senior director Yuanjing Xu points to treatments approved by China’s Center for Drug Evaluation (CDE) in 2020, noting that the country has mostly approved class 1 innovative chemical drugs, with 694 total treatments approved. cardiovascular therapies are dominating areas of focus. In addition, there were 500 biological products approved, with oncology, dermatology and endocrinology being key therapy areas. Our analysis shows that in recent years, a handful of prominent Western pharmaceutical companies have increased their activity in
China.Novartis, for instance, has conducted 9% of its single-country trials in China since the beginning of 2016, compared with only 3% between 2010 and 2015. Roche has also increased its share of single-country trials in China, from 4.5% to 7.5%. Apart from big pharma, several other
companies based in the West have also begun to focus on China. Sandoz has conducted over 60% of its single-country trials since 2016 in the country. Meanwhile, over 90% of CRO Catalent’s collaboration on single-country trials have been with Western companies on trials based in China, particularly in oncology.
Why China as a trial destination? There are several reasons why clinical trial sponsors are intrigued about running clinical trials in China. Cisema’s King says the main driver is for the sponsor to sell a product locally. While it’s possible to secure market approval without local data, it would be a challenging obstacle to
20 | Outsourcing in Clinical Trials Handbook
overcome, he adds. Cisema focuses on China and the Hong Kong market. Still, regardless of sponsor intentions in
marketing locally, China data is desirable as a part of collective global data either for early development or a registrational trial, Xu notes. It’s not expensive to run clinical trials in China
– even sponsors with a limited budget can do so, says Cleveland Clinic professor Daniel Sessler. Patients in the area are seeing clinical trials as opportunities to access new therapies, and this can help accelerate recruitment, Xu adds.
Large pool of patients for trials China has a large patient population that meets eligibility criteria and is treatment-naïve, Xu notes. Cleveland Clinic vice chair of research Dr Andrea Kurz says that if the trial requires more than 5,000 patients, large hospitals in China become attractive. Sessler and Kurz are primary investigators in an ongoing non-small lung cell cancer trial that is only recruiting in Shanghai. The country also has a robust clinical trial infrastructure. With many established clinical trial sites with skilled teams, a network of experienced therapeutic experts, and advanced technologies in use, there is a sturdy foundation to support clinical trial operations successfully in China. Meanwhile, the number of trials using remote, virtual or decentralised rose during the COVID-19 pandemic and continue to rise. Focused on improving its regulatory system,
China’sNational Medical Products Administration (NMPA) has made updates to its product review and registration processes to help enhance says. Regulatory acceleration mechanisms from the NMPA, such as breakthrough and orphan designations, priority reviews and reimbursement reforms, encourage earlier application and accelerate approval for innovations, he adds.
Clinical trial challenges in China King says it hasn’t been a challenge to run clinical trials in China in the past two years owing to the country’s zero-COVID approach. However, on-site visits have been impeded by travel restrictions from overseas, Kurz notes. The situation in certain major cities has been affected by severe lockdowns imposed to maintain the lockdowns are in various areas, and you need
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