This study assesses the impact of the 1993 NIH Revitalization Act

This study assesses the impact of the 1993 NIH Revitalization Act on the inclusion and subgroup analysis of women and minorities in trials of FDA-approved smoking cessation pharmacotherapy. NIH recommendations, minority EMCN organizations included Hispanic or Latino, American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or Additional Pacific Islander. Published papers reporting the primary findings from a given trial as well as secondary publications were evaluated. Given that the NIH Revitalization Take action was approved in June 1993 and the producing NIH requirements for the inclusion of ladies and minorities were released in 1994, we compared tests initiating subject recruitment before 1994 with tests initiating subject Tolvaptan IC50 recruitment during and after 1994. When day of initiation of subject recruitment was not included in a report, we contacted the related author to obtain this info. We also recognized funding resource (i.e., NIH or pharmaceutical organization) wherever possible and reviewed published reports for results of subgroup analyses to determine whether gender or racial variations existed in results. All info was retrieved from content articles by two investigators in order to reduce the probability of error. Statistical Analysis Our analysis plan was similar to a prior review of female and minority representation Tolvaptan IC50 in medical trial study (15). First, independent Chi-square analyses were conducted to compare the number of studies reporting the gender and ethnic/racial breakdowns of their samples and the number of tests reporting results of end result analyses by gender and by race/ethnicity according to 1 1. recruitment Tolvaptan IC50 period (before 1994 and Tolvaptan IC50 from 1994-on) and 2. funding resource (NIH versus pharmaceutical sponsored). Funding comparisons were limited to NIH versus pharmaceutical sponsored because there were insufficient numbers of tests funded through additional means to permit a comparison. Hierarchical logistic regressions were then used to examine effects of all variables of interest in the same analysis. Recruitment period, funding resource and sample were came into in the 1st step of the analysis. The purpose of the sample variable was to assess effect of the sample size of the trial. In the second step, we examined the connection of recruitment period and funding source to address the possibility that the passage of the NIH Revitalization Take action led to a greater change in reporting in NIH-funded tests than in pharmaceutical sponsored tests. Trials enrolling specifically females or specifically users of minority organizations were not included in these analyses because neither examination of representation nor subgroup analyses was possible. An analogous process was used to assess variations regarding the percentage of female and minority participants included in tests that reported this information. Separate was included like a covariate and recruitment period was the sole self-employed variable. A second set of was then conducted including these two variables as well as funding type and the recruitment period x funding interaction. Tests enrolling specifically females or users of minority organizations were excluded from these analyses because the inclusion of these tests would dramatically alter sample variance and potentially produce misleading results. Confirmatory analyses were carried out by collapsing across tests and comparing the overall representation of females and minorities among the group of tests beginning recruitment before 1994 and the group of tests beginning recruitment Tolvaptan IC50 from 1994 to the present, using chi-square. Tests enrolling only females or users of minority organizations were included in the confirmatory analyses collapsing across tests. Results A total of 127 published reports from 80 United States-based smoking tests were included in the review. Forty-four tests (55%) began recruitment before 1994 and thirty-six (44%) began recruitment during 1994 or later on. We were able to identify the funding resource for 75 of the 80 tests (NIH-sponsored = 40, pharmaceutical-sponsored = 31, additional funding = 4). Sixty-two of the tests tested NRT, 14 tested bupropion, 1 tested varenicline, 2 tested both varenicline and bupropion,.

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