# US 2013/0158951 A1 · Methods and apparatus for analyzing test data in determining the effect of drug treatments > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158951 A1 - Document ID: US20130158951A1 - Status: Published application - Kind: A1 - Application number: 13/678,598 - Filed: 2012-11-16 - Published: 2013-06-20 - Earliest claimed: 2011-11-30 - Assignees: Boehringer Ingelheim International GmbH - Inventors: Xidong JIN; Timothy MUIR - Web page: https://patentgrep.com/patent/US20130158951A1 ## CPC - G06F 17/18: for evaluating statistical data {, e.g. average values, frequency distributions, probability functions, regression analysis (forecasting specially adapted for a specific administrative, business or logistic context G06Q10/04)} - G16H 10/20: for electronic clinical trials or questionnaires - G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients - G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract Methods and apparatus provide for: receiving pre-clinical data measured during drug treatment of a plurality of mammals including at least two treatment groups; performing at least one EXACT, non-parametric, statistical hypothesis test comparing the pre-clinical data for the at least two treatment groups; and performing a Multiple Comparison Procedure (MCP) on the pre-clinical data for at least two comparisons, where the EXACT, non-parametric, statistical hypothesis test and the MCP are conducted on the pre-clinical data to produce one or more p-values, each p-value representing whether an associated one of the treatment groups has experienced a statistically significant improvement or decline in one or more conditions of the mammals associated with the treatment. ## Claims ### Claim 1 A method, comprising: receiving pre-clinical data measured during drug treatment of a plurality of mammals including at least two treatment groups; performing at least one EXACT, non-parametric, statistical hypothesis test comparing the pre-clinical data for the at least two treatment groups; and performing a Multiple Comparison Procedure (MCP) on a result of the EXACT, non-parametric, statistical hypothesis test for at least two comparisons resulting from comparing the pre-clinical data, wherein the EXACT, non-parametric, statistical hypothesis test and the MCP are conducted to produce one or more p-values, each p-value representing whether an associated one of the treatment groups has experienced a statistically significant improvement or decline in one or more conditions of the mammals associated with the treatment. ### Claim 2 (depends on 1) The method of claim 1, wherein the EXACT, non-parametric, statistical hypothesis test is taken from the group consisting of: the EXACT Mann-Whitney test, and the EXACT Kruskal-Wallis test. ### Claim 3 (depends on 1) The method of claim 1, wherein the EXACT, non-parametric, statistical hypothesis test is the EXACT Mann-Whitney test. ### Claim 4 (depends on 1) The method of claim 1, wherein the MCP is taken from the group consisting of the Holm-Bonferroni Correction, the Bonferroni Correction, the false discovery rate (FDR) correction, and the Benjamini-Hochberg Correction. ### Claim 5 (depends on 1) The method of claim 1, wherein the MCP is the Holm-Bonferroni Correction test. ### Claim 6 (depends on 1) The method of claim 1, further comprising: monitoring an amount of time elapsing during the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data; and determining whether the amount of time exceeds a predetermined threshold. ### Claim 7 (depends on 6) The method of claim 6, further comprising interrupting the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data of one or more of the comparisons when the determination is in the affirmative. ### Claim 8 (depends on 7) The method of claim 7, further comprising: performing a Monte Carlo simulation/estimation method of statistical analysis on the pre-clinical data of the one or more of the comparisons, after interrupting the performance of the EXACT, non-parametric, statistical hypothesis test; and performing the MCP on results of at least one of the EXACT, non-parametric, statistical hypothesis test and the Monte Carlo simulation method for the at least two comparisons to produce the one or more p-values. ### Claim 9 A method, comprising: receiving pre-clinical data measured during drug treatment of a plurality of mammals including at least two treatment groups; performing at least one EXACT, non-parametric, statistical hypothesis test comparing the pre-clinical data for the at least two treatment groups; monitoring an amount of time elapsing during the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data; determining whether the amount of time exceeds a predetermined threshold; completing the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data when the determination is in the negative, and interrupting the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data when the determination is in the affirmative; performing a Monte Carlo simulation method of statistical analysis on the pre-clinical data of at least one of the comparisons, if the determination is in the affirmative and the performance of the EXACT, non-parametric, statistical hypothesis test is interrupted; performing a Multiple Comparison Procedure (MCP) on the results of at least one of the EXACT, non-parametric, statistical hypothesis test and the Monte Carlo simulation method for at least two comparisons, wherein the EXACT, non-parametric, statistical hypothesis test, the Monte Carlo simulation method, and the MCP are conducted to produce one or more p-values, each p-value representing whether an associated one of the treatment groups has experienced a statistically significant improvement or decline in one or more conditions of the mammals associated with the treatment. ### Claim 10 An apparatus, including a processor operating to perform actions in response to executing computer program instructions, the actions comprising: receiving pre-clinical data measured during drug treatment of a plurality of mammals including at least two treatment groups; performing at least one EXACT, non-parametric, statistical hypothesis test comparing the pre-clinical data for the at least two treatment groups; and performing a Multiple Comparison Procedure (MCP) on a result of the EXACT, non-parametric, statistical hypothesis test for at least two comparisons, wherein the EXACT, non-parametric, statistical hypothesis test and the MCP are conducted to produce one or more p-values, each p-value representing whether an associated one of the treatment groups has experienced a statistically significant improvement or decline in one or more conditions of the mammals associated with the treatment. ### Claim 11 (depends on 10) The apparatus of claim 10, wherein the EXACT, non-parametric, statistical hypothesis test is taken from the group consisting of: the EXACT Mann-Whitney test, and the EXACT Kruskal-Wallis test. ### Claim 12 (depends on 10) The apparatus of claim 10, wherein the EXACT, non-parametric, statistical hypothesis test is the EXACT Mann-Whitney test. ### Claim 13 (depends on 10) The apparatus of claim 10, wherein the MCP is taken from the group consisting of the Holm-Bonferroni Correction, the Bonferroni Correction, the false discovery rate (FDR) correction, and the Benjamini-Hochberg Correction. ### Claim 14 (depends on 10) The apparatus of claim 10, wherein the MCP is the Holm-Bonferroni Correction. ### Claim 15 (depends on 10) The apparatus of claim 10, further comprising: monitoring an amount of time elapsing during the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data; and determining whether the amount of time exceeds a predetermined threshold. ### Claim 16 (depends on 15) The apparatus of claim 15, further comprising interrupting the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data of one or more of the comparisons when the determination is in the affirmative. ### Claim 17 (depends on 16) The apparatus of claim 16, further comprising: performing a Monte Carlo simulation/estimation method of statistical analysis on the pre-clinical data of the one or more of the comparisons, after interrupting the performance of the EXACT, non-parametric, statistical hypothesis test; and performing the Multiple Comparison Procedure (MCP) on results of at least one of the EXACT, non-parametric, statistical hypothesis test and the Monte Carlo simulation method for the at least two comparisons to produce the one or more p-values. ### Claim 18 An apparatus including a processor operating to perform actions in response to executing computer program instructions, the actions comprising: receiving pre-clinical data measured during drug treatment of a plurality of mammals including at least two treatment groups; performing at least one EXACT, non-parametric, statistical hypothesis test comparing the pre-clinical data for the at least two treatment groups; monitoring an amount of time elapsing during the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data; determining whether the amount of time exceeds a predetermined threshold; completing the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data when the determination is in the negative, and interrupting the performance of the EXACT, non-parametric, statistical hypothesis test on the pre-clinical data of one or more comparisons when the determination is in the affirmative; performing a Monte Carlo simulation method of statistical analysis on the pre-clinical data of the one or more comparisons, if the determination is in the affirmative and the performance of the EXACT, non-parametric, statistical hypothesis test is interrupted; performing a Multiple Comparison Procedure (MCP) on results of at least one of the EXACT, non-parametric, statistical hypothesis test and the Monte Carlo simulation method for at least two comparisons, wherein the EXACT, non-parametric, statistical hypothesis test, or the Monte Carlo simulation method, and the MCP are conducted to produce one or more p-values, each p-value representing whether an associated one of the treatment groups has experienced a statistically significant improvement or decline in one or more conditions of the mammals associated with the treatment. ### Claim 19 (depends on 18) The apparatus of claim 18, wherein: the at least two treatment groups include at least a control group and at least two further treatment groups; and the apparatus operates to query a user of the apparatus to select which treatment groups are to be compared using the EXACT, non-parametric, statistical hypothesis test, or the Monte Carlo simulation method, and the MCP. ### Claim 20 (depends on 19) The apparatus of claim 19, wherein the apparatus operates to query a user of the apparatus to select the predetermined threshold.