抗病毒口服液治疗成人感冒上市后再评价的设计思路与方法

Design Ideas and Methods for Post-market Re-evaluation of Anti-virus Oral Liquid in Treatment of Adult Cold

抗病毒口服液治疗成人感冒的上市后再评价研究在设计阶段综合分析了申办方研究定位、研究背景与研究基础进而提出研究假设,即抗病毒口服液治疗成人感冒扩大剂量后疗效显著,确定选用随机对照试验验证研究假设。其中关键要素如受试者、干预措施、对照和结局指标的设计主要参考了抗病毒口服液组方特点,推测其适合的症状、参考药品说明书、前期网站调查和临床医生访谈结果,并综合国外普通感冒药物的临床试验进行设计。同时本研究针对影响研究质量的潜在风险,在方案中进行了质量控制内容和方法的设计。

During the design of the post-market re-evaluation study of antiviral oral liquid in the treatment of adult cold,the hypothesis was put forward based on the comprehensive analysis of the sponsor＇s research orientation,research background and research basis,which was that the anti-viral oral solution had a significant effect on adult cold after expanding dose. The randomized controlled trial was determined to verify the hypothesis. The key elements such as subjects,interventions,controls and outcome indicators were designed with reference to the characteristics of the Chinese herb combinations in the formula to infer the indications,the instruction,the early website survey,results of clinician interviews and foreign clinical trials of common cold drugs. At the same time,this study designed the contents and methods to control the quality against the potential risks that might affect the quality of study.