| 摘要 |
The present invention provides a method, apparatus, and computer instructions for improved control of clinical trials. In a preferred embodiment, after a clinical trial is initiated, data is regularly cleaned and processed to statistically analyze the data. The outcome includes a predictive measure of the timing and level by which the study will achieve one or more statistically significant levels, allowing mid-course modifications to the study (e.g., in population size, termination, etc.). Modification can be planned as part of the initial protocol, using thresholds or other appropriate criteria relating to the statistical outcome, making possible pre-approved protocol changes based on the statistical findings. This process has significant implications for the management of clinical studies, including ensuring the minimum possible time and number of patients are used in clinical studies to either prove (or disprove) the clinical efficacy of drugs or treatments. |
