Growing China’s capacity to conduct high-quality trials

How companies are engaging new PIs and clinical centers to bring more trials to China

As more companies conduct clinical trials in China, they are facing increasingly steep competition for patients and PIs at the country’s small number of established clinical trial centers. To break the logjam and tap a larger portion of China’s huge patient population, some sponsors and CROs are cautiously working new sites into their networks.

The challenge is not sacrificing data quality at a time when Chinese companies are just beginning to convince the world that they can produce high-caliber clinical research.

Regulatory reforms have paved the way to get innovative drugs on the Chinese market, including shortening NDA review timelines and reimbursing innovative drugs (see “When a First-in-China Regulatory Strategy Makes Sense”).

Just as the sheer volume of patients in China makes the country an attractive market opportunity, it also makes China attractive from a clinical development perspective. The promise of all those patients is faster enrollment.

“If we start thinking of China as a key global center of clinical development, it may have a significant impact on the speed at which drugs can be developed.”

George Baeder, dMed Biopharmaceutical Co. Ltd.

“If we start thinking of China as a key global center of clinical development, it may have a significant impact on the speed at which drugs can be developed,” George Baeder told BioCentury. Baeder is SVP of strategy and business development at CRO dMed Biopharmaceutical Co. Ltd.

And while there have been

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