Anne Poli of Stat reports that in China, with its huge population and its position as the second-largest pharmaceutical market in the world, should be poised to become a world leader in clinical trials for new drugs and devices. But it isn’t quite ready for that.
Problems with protecting clinical trial participants, inadequate clinical trial infrastructure, and poor transparency make China an unreliable country in which to conduct a clinical trial. As a clinical research professional with more than a decade of global industry experience, I’ve seen clinical trials conducted in many countries but have yet to work with a U.S. company that has opted to conduct a clinical trial in China.
Protecting human subjects is a fundamental part of clinical trials. When deciding where to conduct one, pharmaceutical and medical technology companies must select countries that have adequate protections in place. China has had issues and challenges with protecting human subjects for years. A historical lack of clinical research infrastructure in China has led to problems adhering to Good Clinical Practice, the international gold standard for maintaining ethical and quality standards in clinical trials. See the rest of this interesting article: https://www.statnews.com/2018/