Statistical Issues in Regulatory Review

• 作 者: MeyWang;
• 机 构: Division of Clinical Sciences Center for Drug Evaluation Taiwan
• 出 处: 中国上海第七届国际新药发明科技年会
• 发表日期: 2009年期

　　The regulatory standards for the approval of a new drug in the claimed indication are that it needs substantial evidence of efficacy and safety from clinical trials.Considering the critical role of clinical trials in the drug approval process,the regulatory agencies often require the sponsors to provide adequate and well controlled trials with high level of confidence in the validity of the results.An adequate statistical design can minimize bias and variability associated with the trial,and an appropriate statistical method can provide a fair and unbiased assessment of the effectiveness and safety of the study drug with certain assurance.In this presentation,it will first be introduced briefly the guideline of statistical principles for clinical trials.Following for a scientifically meaningful clinical trial,issues that are often debated will be discussed with regards to sample size,efficacy endpoint,combined drug efficacy,non-inferiority/equivalence margin,adaptive trial design,etc.