摘要
偏离及违反方案的情况及发生率尽管不可避免,但是要尽一切努力,并采取积极措施,减少其发生,因为严重的违反方案会直接影响试验数据的质量,进而影响试验的结果,甚至左右该新药能否通过政府药政主管机构的核决。
Although bias and violation to the clinical trial protocol cannot be avoided,any effort should be exerted and positive measures should be taken to reduce its occurrence,because serious violation of the clinical trial protocol can directly affect the data quality of clinical trial,thereby affecting the trial result,and even can influence the verification and approval of a new drug by the regulators.
出处
《中国处方药》
2010年第10期70-71,共2页
Journal of China Prescription Drug
