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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9

Cho thấy các kết quả của các trang web điều trị khác nhau có thể được kết hợp. Nếu điểm cuối là nhị phân trong thành công bản chất so với không sử dụng thử nghiệm (1971) Zelen của các tỷ lệ cược tương đương với tỷ lệ 2 × 2 bảng. Nếu nó xuất hiện một hoặc nhiều địa điểm điều trị nên được loại trừ | that the groups are comparable but rather that randomization was effective. See also Altman and Dore 1990 . Show that the results of the various treatment sites can be combined. If the endpoint is binary in nature success vs. failure employ Zelen s 1971 test of equivalent odds ratios in 2 X 2 tables. If it appears that one or more treatment sites should be excluded provide a detailed explanation for the exclusion if possible repeated protocol violations ineligible patients no control patients misdiagnosis and exclude these sites from the subsequent analysis.46 Determine which baseline and environmental factors if any are correlated with the primary end point. Perform a statistical test to see whether there is a differential effect between treatments as a result of these factors. Test to see whether there is a differential effect on the end point between treatments occasioned by the use of any adjunct treatments. Reporting Primary End Points Report the results for each primary end point separately. For each end point 1. Report the aggregate results by treatment for all patients who were examined during the study. 2. Report the aggregate results by treatment only for those patients who were actually eligible who were treated originally as randomized or who were not excluded for any other reason. Provide significance levels for treatment comparisons. 3. Break down these latter results into subsets based on factors predetermined before the start of the study such as adjunct therapy or gender. Provide significance levels for treatment comparisons. 4. List all factors uncovered during the trials that appear to have altered the effects of treatment. Provide a tabular comparison by treatment for these factors but do not include p-values. If there were multiple end points you have the option of providing a further multivariate comparison of the treatments. Exceptions Every set of large-scale clinical trials has its exceptions. You must report the raw numbers of such .