Cancer Drug Developers Cry Foul As Costs Soar In China
Sheer volume of studies and fierce competition to recruit and enroll required numbers of patients in trials, even in a populous country like China, can quickly jack up new drug development costs.
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Any delays caused by unpredictable regulatory reviews related to the export of genetic materials threaten to derail the inclusion of China in international clinical trials, caution two trade groups representing the pharma industry in the country.
As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.
China's drug regulatory authority is taking aim at strengthening randomized, controlled clinical trials conducted domestically for cancer drugs, leaving biotech stocks reeling from the proposed stricter requirements.