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38P Thrombolysis in acute stroke pooling project (TAS-PP): A prospective pooled individual patient database
99S
Abstracts
38P THROMEOLYSIS IN ACUTE STROKE POOLING PROJECT (TAS-PP): A PROSPECTIVE POOLED INDIVIDUAL PATIENT DATABASE Catherine Cornu on behalf of the TAS-PP Group
Unit~ de Pharmacologic Clinique Lyon, France There is increasing interest in the techniques of meta-analysis, mostly applied to summary data from clinical trials. This approach has the advantage of enhanced statistical power. However the individual specificity of the patients is not explored. Performing metaanalysis on indivi~J~ patient d~t~ can overcome this deficiency, enables intention-to-treat and subgroup analyses to be performed and various factors to be studied in relation to a specific event. The Thrombolysis in Acute Stroke Pooling Project (TAS-PP) is a prospective pooling project of d~t, from thrombolysis trials in acute ischem/c stroke. The trials which will be included in the meta analysis have not been completed, and therefore, we can attempt to homogenize the protocols and the d~t~ collected. The objective of TAS-PP is to answer two questions: I) is thrombolysis a beneficial treatment in acute stroke for both short-term total mortafity and long-term disability in stroke survivors? and 2) which patients benefit most from the treatment? Trials which can be considered for inclusion are those which are randomized, have a sample size of more than 10, are completed, on-going or planned clhdcal trials in acute ischennc stroke, involving a thrombolytic treatment. The identified "stroke thrombelytic trialists" who collaborate have defined a common core of d~t~ to be collected, and they will identify other trials and approach other trialists. The analysis will be performed using modelling techniques on the individual d~tm, pooled in a common file. The results of the study will be expressed in the form of subgroups with different levels of benefit, in order to define inclusion criteria for a further study to vali~tqte these results. TAS-PP has two active units: 1) The Steering Committee, composed of representatives from each trial, which is responsible for defining the objectives, elaborating the protocol, deciding on future policies and the publishing policy. 2) The Data Handling Unit, which is responsible for the aot~ collection, updating the common file, checking a~t. and running the analyses. The secretariat of the project is located in the same unit.
39P METHODS FOR MONITORING CLINICAL TRIALS L. Douglas Case, Timothy M. Morgan and C. E. Davis
The Comprehensive Cancer Center of Wake Forest University Bowman Gray School of Medicine W"mston-Salem, North Carolina Accumulating d~t~ from clinical trials are usually reviewed multiple times before the study is complete due to the ethic~d concern for the patient's well-being. Investigators do not want to continue trials in which one therapy is clearly superior, nor do they want to continue trials in which there is little hope of showing a benefit. In many cases, continuous monitoring is not practical, and group sequential methods are used. We present optimal three-stage designs with equal sample sizes at each stage. These designs are compared to fixed sample designs, fully sequential designs, designs restricted to use the fixed sample critical value at the final stage, and to modifications of other designs previously proposed in the literature. Typically, the greatest savings realized with interim analyses are obtained by the first interim
Abstracts
38P THROMEOLYSIS IN ACUTE STROKE POOLING PROJECT (TAS-PP): A PROSPECTIVE POOLED INDIVIDUAL PATIENT DATABASE Catherine Cornu on behalf of the TAS-PP Group
Unit~ de Pharmacologic Clinique Lyon, France There is increasing interest in the techniques of meta-analysis, mostly applied to summary data from clinical trials. This approach has the advantage of enhanced statistical power. However the individual specificity of the patients is not explored. Performing metaanalysis on indivi~J~ patient d~t~ can overcome this deficiency, enables intention-to-treat and subgroup analyses to be performed and various factors to be studied in relation to a specific event. The Thrombolysis in Acute Stroke Pooling Project (TAS-PP) is a prospective pooling project of d~t, from thrombolysis trials in acute ischem/c stroke. The trials which will be included in the meta analysis have not been completed, and therefore, we can attempt to homogenize the protocols and the d~t~ collected. The objective of TAS-PP is to answer two questions: I) is thrombolysis a beneficial treatment in acute stroke for both short-term total mortafity and long-term disability in stroke survivors? and 2) which patients benefit most from the treatment? Trials which can be considered for inclusion are those which are randomized, have a sample size of more than 10, are completed, on-going or planned clhdcal trials in acute ischennc stroke, involving a thrombolytic treatment. The identified "stroke thrombelytic trialists" who collaborate have defined a common core of d~t~ to be collected, and they will identify other trials and approach other trialists. The analysis will be performed using modelling techniques on the individual d~tm, pooled in a common file. The results of the study will be expressed in the form of subgroups with different levels of benefit, in order to define inclusion criteria for a further study to vali~tqte these results. TAS-PP has two active units: 1) The Steering Committee, composed of representatives from each trial, which is responsible for defining the objectives, elaborating the protocol, deciding on future policies and the publishing policy. 2) The Data Handling Unit, which is responsible for the aot~ collection, updating the common file, checking a~t. and running the analyses. The secretariat of the project is located in the same unit.
39P METHODS FOR MONITORING CLINICAL TRIALS L. Douglas Case, Timothy M. Morgan and C. E. Davis
The Comprehensive Cancer Center of Wake Forest University Bowman Gray School of Medicine W"mston-Salem, North Carolina Accumulating d~t~ from clinical trials are usually reviewed multiple times before the study is complete due to the ethic~d concern for the patient's well-being. Investigators do not want to continue trials in which one therapy is clearly superior, nor do they want to continue trials in which there is little hope of showing a benefit. In many cases, continuous monitoring is not practical, and group sequential methods are used. We present optimal three-stage designs with equal sample sizes at each stage. These designs are compared to fixed sample designs, fully sequential designs, designs restricted to use the fixed sample critical value at the final stage, and to modifications of other designs previously proposed in the literature. Typically, the greatest savings realized with interim analyses are obtained by the first interim