RE: Clinical Trials - PD-(L)14 Nov 2019 21:38
From the same article.................. China Again!!..................
China has the highest recruitment rate
We calculated the median patient recruitment rate per clinical site in the USA, China, six other major markets (France, Germany, Italy, Japan, Spain and the UK), and the Asia-Pacific area (Australia, Hong Kong, Korea, New Zealand, Taiwan and Thailand) by using the patient recruitment rate of 629 clinical sites from 55 completed or ongoing PD-1/PD-L1 clinical trials managed by IQVIA. The USA has the lowest patient recruitment rate, probably owing to the highest penetration of PD-1/PD-L1 mAbs as standard of care. By contrast, the patient recruitment rate in China is almost six times higher for monotherapy trials and about four times higher for combination therapy than in the USA (Fig. 3). China has more than 4 million new cancer cases per year and most Chinese cancer patients do not receive PD-1/PD-L1 mAbs, which means the country has the largest number of patients who are eligible to join clinical trials.
Indeed, the clinical development of the three China-derived marketed PD-1 mAbs (sintilimab, toripalimab and camrelizumab) by Chinese companies was rapid (26–45 months) compared with the rest of the approved PD-1/PD-L1 mAbs, which was aided by the fast patient recruitment for these clinical trials. As China recently joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), data generated from trials in China may support market applications in other ICH member countries. The global PD-1/PD-L1 trial community should make use of this precious patient resource to accelerate clinical development.
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