Sather Mike R, Raisch Dennis W, Haakenson Clair M, Buckelew Julia M, Feussner John R
VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Research and Development, Albuquerque, New Mexico, USA.
Control Clin Trials. 2003 Oct;24(5):570-84. doi: 10.1016/s0197-2456(03)00074-6.
The ever-increasing concern for the welfare of volunteers participating in clinical trials and for the integrity of the data derived from those trials has generated the concept of Good Clinical Practice (GCP). The Veterans Affairs Cooperative Studies Program, in anticipation of the need to comply with GCP guidelines, developed a Site Monitoring and Review Team (SMART), which consists of a Good Clinical Practice Monitoring Group and a Good Clinical Practice Review Group. The review group conducted 335 site reviews from fiscal years (FY) 1999 through 2001 to assess and encourage adherence to GCP. Data from reviews were compared for two time periods, a 2-year implementation period (FYs 1999/2000, n=204) and a continuing follow-up period (FY 2001, n=131). Overall, high GCP adherence was exhibited by 11.3% (n=23) of study sites in FY 1999/2000 versus 20.6% (n=27) in FY 2001, average to good adherence was exhibited by 84.3% (n=172) in FY 1999/2000 versus 77.0% (n=101) in FY 2001, and below average adherence was exhibited by 4.4% (n=9) versus 1.5% (n=3) in these two periods. These changes were statistically significant by chi square analysis (p=0.029). Moreover, GCP adherence was assessed within eight GCP focus areas: patient informed consent, protocol adherence, safety monitoring, institutional review board interactions, regulatory document management, patient records in investigator file, drug/device accountability, and general site operations. Median assessment scores for all 62 GCP review elements improved from 0.82 to 0.89 (p<0.001). Median assessment scores for the 14 selected critical GCP items improved from 0.78 to 0.89 (p<0.001). Median scores for five of the eight GCP focus areas improved significantly (p<0.001) between the two time periods. These data suggest that the site-oriented activities of SMART combined with centralized quality assurance activities of the coordinating centers represent an integrated, versatile program to promote and assure GCP adherence and data integrity in Cooperative Studies Program trials.
对参与临床试验的志愿者福利以及源自这些试验的数据完整性的日益关注催生了良好临床实践（GCP）的概念。退伍军人事务部合作研究计划预计需要遵守GCP指南，因此组建了一个现场监测与审查团队（SMART），该团队由一个良好临床实践监测小组和一个良好临床实践审查小组组成。审查小组在1999财年至2001财年期间进行了335次现场审查，以评估并鼓励对GCP的遵守情况。对审查数据在两个时间段进行了比较，一个是为期2年的实施期（1999/2000财年，n = 204），另一个是持续的随访期（2001财年，n = 131）。总体而言，1999/2000财年有11.3%（n = 23）的研究站点表现出高度遵守GCP，而2001财年这一比例为20.6%（n = 27）；1999/2000财年有84.3%（n = 172）的站点表现出中等至良好的遵守情况，2001财年这一比例为77.0%（n = 101）；在这两个时间段中，低于平均遵守水平的站点比例分别为4.4%（n = 9）和1.5%（n = 3）。通过卡方分析，这些变化具有统计学意义（p = 0.029）。此外，在八个GCP重点领域对GCP遵守情况进行了评估：患者知情同意、方案遵守、安全监测、机构审查委员会互动、监管文件管理、研究者档案中的患者记录、药物/器械 accountability以及一般现场操作。所有62个GCP审查要素的中位数评估得分从0.82提高到了0.89（p < 0.001）。14个选定的关键GCP项目的中位数评估得分从0.78提高到了0.89（p < 0.001）。在两个时间段之间，八个GCP重点领域中的五个领域的中位数得分有显著提高（p < 0.001）。这些数据表明，SMART以站点为导向的活动与协调中心的集中质量保证活动相结合，代表了一个综合、多功能的计划，以促进并确保合作研究计划试验中对GCP的遵守以及数据的完整性。
