SYSTEMS AND METHODS FOR TRACKING AND DESIGNING CLINICAL TRIALS
First Claim
1. A computer-implemented method of conducting a clinical trial including multiple clinical trial sites, comprising:
- receiving progress data for the clinical trial;
creating database entries in a database based on the progress data;
determining projection ratios of clinical trial subjects screened, enrolled, and randomized at each clinical trial site based on the database entries;
modeling a projected outcome of the clinical trial based on the database entries and the determined ratios;
supplementing the database entries based on the progress data with additional data received from one or more of the clinical trial sites;
updating the modeled potential outcome based on the additional data; and
adjusting, via a user interface linked to the database, the number of clinical trial sites in the clinical trial based on the ratios and the updated modeled scenario.
1 Assignment
0 Petitions
Accused Products
Abstract
Systems, apparatuses, and methods are provided for planning, activating, analyzing, and monitoring clinical trials. A planning process gathers clinical trial initiation parameters and produces a clinical trial plan. An activation process prepares and activates clinical sites in various countries to screen, enroll, and provide clinical trial drugs or devices to subjects. An analysis process tracks the rate at which trial completion objectives are completed and models progress scenarios (e.g., best case, worst case, base, etc.) and potential outcomes. Finally, a monitoring process allows a clinical trial manager to monitor the progress of the clinical trial and modify the clinical trial plan as needed to meet trial completion objectives.
9 Citations
20 Claims
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1. A computer-implemented method of conducting a clinical trial including multiple clinical trial sites, comprising:
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receiving progress data for the clinical trial; creating database entries in a database based on the progress data; determining projection ratios of clinical trial subjects screened, enrolled, and randomized at each clinical trial site based on the database entries; modeling a projected outcome of the clinical trial based on the database entries and the determined ratios; supplementing the database entries based on the progress data with additional data received from one or more of the clinical trial sites; updating the modeled potential outcome based on the additional data; and adjusting, via a user interface linked to the database, the number of clinical trial sites in the clinical trial based on the ratios and the updated modeled scenario. - View Dependent Claims (2, 3, 4)
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5. A computer-implemented method of conducting a clinical trial including multiple clinical trial sites in multiple countries, comprising:
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establishing a plan for the clinical trial that comprises a time period, a target number of clinical trial subjects to be randomized in the clinical trial, and a list of one or more countries in which the clinical trial will be conducted; storing the clinical trial plan in a database; activating, via a user interface linked to the database, one or more clinical trial sites for the clinical trial to enable the activated sites to begin screening subjects; receiving first progress data for the clinical trial from one or more clinical trial sites; creating database entries in a database based on the first progress data; determining ratios based on the database entries, the ratios corresponding to the number of clinical trial subjects screened, enrolled, and randomized per activated clinical trial site per month; receiving updated progress data from one or more of the activated clinical trial sites; supplementing the database entries based on the updated progress data; monitoring the clinical trial based on the first progress data and the updated progress data; and modifying the clinical trial plan in the database based on the monitoring. - View Dependent Claims (6, 7, 8, 9, 10)
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11. A computer-implemented method of conducting a clinical trial including multiple clinical trial sites in multiple countries, comprising:
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establishing a plan for the clinical trial, wherein the plan comprises a number of countries required for successful completion of the clinical trial and a number of clinical trial sites within each country; storing the plan for the clinical trial in a database; activating, via a user interface linked to the database, one or more countries required for successful completion of the clinical trial based on the clinical trial plan; activating, via a user interface linked to the database, one or more clinical trial sites within each country based on the clinical trial plan to enable to the activated sites to begin screening subjects; receiving progress data from one or more clinical trial sites; creating database entries in the database based on the received progress data; modeling a potential outcome of the clinical trial based on the database entries; modifying the clinical trial plan based on the modeled potential outcome. - View Dependent Claims (12, 13, 14, 15)
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16. A system for conducting a clinical trial including multiple clinical trial sites, comprising:
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a memory containing instructions; and one or more processors configured to execute the instructions to; receive progress data for the clinical trial; create database entries in a database based on the progress data; determine projection ratios of clinical trial subjects screened, enrolled, and randomized at each clinical trial site based on the database entries; model a projected outcome of the clinical trial based on the database entries and the determined ratios; supplement the database entries based on the progress data with additional data received from one or more of the clinical trial sites; update the modeled potential outcome via a user interface linked to the database based on the additional data; and adjust, via a user interface linked to the database, the number of clinical trial sites in the clinical trial based on the ratios and the updated modeled scenario. - View Dependent Claims (17, 18, 19)
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20. A clinical trial manager system for conducting a clinical trial, comprising:
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a memory containing instructions; and one or more processors configured to execute the instructions to; receive progress data for the clinical trial from a plurality of clinical sites; determine one or more projection ratios of clinical trial subjects screened, enrolled, and/or randomized by at least one of the clinical sites based on the received progress data; make a projection of the clinical trial based on the received progress data and the one or more projection ratios; store the one or more projection ratios and the projection in the memory; and model a scenario of the clinical trial by reviewing at least one of the one or more projection ratios or the projection stored in the memory.
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Specification