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1. (WO2005031509) SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF AN ONGOING CLINICAL TRIAL
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2005/031509 International Application No.: PCT/US2004/030922
Publication Date: 07.04.2005 International Filing Date: 22.09.2004
IPC:
A61B 5/00 (2006.01) ,G01N 33/48 (2006.01) ,G06Q 10/00 (2006.01) ,G06Q 50/00 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
B
DIAGNOSIS; SURGERY; IDENTIFICATION
5
Measuring for diagnostic purposes; Identification of persons
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
33
Investigating or analysing materials by specific methods not covered by groups G01N1/-G01N31/131
48
Biological material, e.g. blood, urine; Haemocytometers
G PHYSICS
06
COMPUTING; CALCULATING; COUNTING
Q
DATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
10
Administration; Management
G PHYSICS
06
COMPUTING; CALCULATING; COUNTING
Q
DATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
50
Systems or methods specially adapted for a specific business sector, e.g. utilities or tourism
Applicants:
MEDIDATA SOLUTIONS, INC. [US/US]; 79 Fifth Avenue New York, NY 10003, US (AllExceptUS)
IKEGUCHI, Edward, F. [US/US]; US (UsOnly)
DEVRIES, Glen, M. [US/US]; US (UsOnly)
SHERIF, Tarek, A. [US/US]; US (UsOnly)
Inventors:
IKEGUCHI, Edward, F.; US
DEVRIES, Glen, M.; US
SHERIF, Tarek, A.; US
Agent:
FULBRIGHT & JAWORSKI L.L.P.; 666 Fifth Avenue New York, NY 10103-3198, US
Priority Data:
10/667,84822.09.2003US
Title (EN) SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF AN ONGOING CLINICAL TRIAL
(FR) SYSTEME ET PROCEDE D'ANALYSE CONTINUE DE DONNEES D'UN ESSAI CLINIQUE EN COURS DE REALISATION
Abstract:
(EN) System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researches because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.
(FR) L'invention concerne un système et un procédé destinés à analyser, de manière continue, des données d'essai d'un essai clinique en cours de réalisation. Une analyse statistique est réalisée sur une base de données d'essai contenant des données d'essai de sujet. Si le résultat de l'analyse statistique ne dépasse pas une valeur seuil prédéterminée, l'analyse statistique est réitérée pendant que l'essai clinique est en cours de réalisation. Dans un essai clinique à l'insu, une base de données groupée est générée à partir de la base de données d'essai et de la base de données d'insu avant la réalisation de l'analyse statistique. La base de données groupée groupe les données d'essai de sujet selon les groupes d'études. La possibilité de surveiller et d'analyser de manière continue les données d'essai en vue de la détermination d'une signification statistique conjointement avec la collecte de données pendant que l'essai est en cours de réalisation offre de nombreux avantages aux chercheurs étant donné que la base de données d'essai cesse d'être un goulot d'étranglement pour l'obtention de résultats utiles, l'analyse statistique pouvant être réalisée en temps presque réel sans qu'il soit nécessaire d'attendre la fin de l'essai.
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Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RU, SC, SD, SE, SG, SK, SL, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IT, LU, MC, NL, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)
Also published as:
EP1673678JP2007506198US20050075832