#InternationalClinicalTrials

Successful International Clinical Trials

EGFR inhibitors

Lung cancer is the most deadly cancer of all — it takes close to two million lives every year. EGFR gene mutations are responsible for a large proportion of lung cancers, and these occur more commonly in Asian women who have never smoked. A number of hugely successful EGFR Inhibitors have been developed over the last decade with significant Chinese contributions, including AstraZeneca’s Tagrisso — which went from first-in-human trial to United States FDA approval in two and a half years instead of 10 to 15 years.

This racial-ethnic diversity and the sheer scale of the Chinese population helped ensure that China’s participation in international trials of EGFR inhibitors significantly accelerated the pace of such cancer drug development worldwide.

Traditionally, international trials have been largely focused on the United States and Europe. Asian participation allows for increased diversity of participants, leading to more rapid discovery and accelerated approvals — reducing the testing period from 10 to 15 years to just two to three years. Now is the time to expand international trials and the diversity of participants to all racial-ethnic backgrounds and geographies, which may accelerate biological discovery and the cure for cancer.

HPV Vaccine

The HPV vaccine Gardasil 9 for cervical cancer was approved in nine days in China after China joined the International Council for Harmonization (ICH) in June 2017. This has meant that, for the first time, mainland China now recognizes the validity of foreign data rather than requiring a repeat of the same trial again in China over an additional period of 10 to 15 years. Reducing that period to just nine days will have an enormous impact in terms of the number of lives saved.

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Dr. Bob Li

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East Asia Clinical Trial Success with Non-Small-Cell Lung Cancer

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Memorial Sloan Kettering and the Chinese Thoracic Oncology Group Urge International Harmonization to Accelerate Cancer Drug Approvals at Annual Event

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