title: Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program.
abstract: 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.
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D017277:Drug Approval; D016903:Drug Monitoring / Q000592:standards*; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D007258:Informed Consent; D011785:Quality Assurance, Health Care; D012108:Research Personnel; D035842:Research Subjects; D012109:Research Support as Topic; D014481:United States; D014493:United States Department of Veterans Affairs
keywords: Biomedical and Behavioral Research; Empirical Approach