Methods and apparatus for planning and management of clinical trials

Abstract

A tool for planning and management of clinical trials. The tool computes a patient enrollment timeline in a clinical trial using multiple factors that bear on the rate of patient enrollment. The factors may be site-dependent factors or may be country-dependent factors. When these factors are applied, different sites may have different rates of enrollment in the same interval. Further, the factors may be time dependent such that even the same sites may have different enrollment rates in different intervals. Once the timeline is created, the tool may use it to calculate a schedule of monitor visits, project trial completion or otherwise generate output used in management of the clinical trial.

What is claimed is: 
     
         1 . A method of operating a computer system comprising a processor to implement a tool for facilitating management of resources during a clinical trial to be performed at a plurality of sites, the method comprising:
 computing a predicted performance of each the plurality of sites;   receiving information relating to conduct of the clinical trial from the plurality of sites;   processing the received information to determine actual performance of each of the plurality of sites;   classifying sites of the plurality of sites based on their actual performance relative to predicted performance;   selectively performing a data processing operation in relation to one or more selected sites based at least in part on the classifications of the sites, wherein the selected data processing operation comprises generating and outputting a schedule for reviewing data generated at the one or more selected sites.   
     
     
         2 . The method of operating the computer system of  claim 1 , wherein:
 receiving information comprises receiving information over a wide area network.   
     
     
         3 . The method of operating the computer system of  claim 2 , wherein:
 receiving information comprises receiving information via a web application.   
     
     
         4 . The method of operating the computer system of  claim 1 , wherein:
 receiving information comprises receiving actual enrollment data.   
     
     
         5 . The method of operating the computer system of  claim 1 , wherein:
 outputting a schedule for reviewing data generated at the site comprises directing a clinical research associate to visit a site.   
     
     
         6 . The method of operating the computer system of  claim 1 , wherein:
 the data processing operation in relation to one or more selected sites is selectively performed based at least in part on an amount of data collected at the selected sites.   
     
     
         7 . The method of operating the computer system of  claim 1 , wherein:
 computing the predicted performance comprises computing a patient enrollment timeline.   
     
     
         8 . A non-transitory computer storage medium encoded with computer-executable instructions that, when executed by a processor, perform a method for executing a clinical trial at a plurality of sites, the method comprising:
 receiving information relating to the performance of the clinical trial from the plurality of sites;   processing the received information to determine actual performance of each of the plurality of sites;   classifying sites of the plurality of sites based on their performance relative to a performance goal; and   selectively performing a data processing operation in relation to one or more selected sites based at least in part on the classifications of the sites, wherein the selected data processing operation comprises generating and outputting instructions for a monitor to review performance of the clinical trial at the one or more selected sites.   
     
     
         9 . The non-transitory computer storage medium of  claim 8 , wherein:
 generating and outputting instructions for a monitor to review performance of the clinical trial at the one or more selected sites comprises generating and outputting a schedule for reviewing data generated at the one or more selected sites.   
     
     
         10 . The non-transitory computer storage medium of  claim 8 , wherein:
 generating and outputting instructions for a monitor to review performance of the clinical trial at the one or more selected sites comprises generating the instructions in part based on progress at the selected sites.   
     
     
         11 . The non-transitory computer storage medium of  claim 10 , wherein:
 generating the instructions in part based on progress at the selected sites comprises computing a projection of patient enrollment at the selected sites based on factors associated with the selected sites.   
     
     
         12 . The non-transitory computer storage medium of  claim 11 , wherein:
 generating the instructions in part based on progress at the selected sites comprises determining whether monitor workload at the individual sites, computed based on the projection of patient enrollment at the selected sites, exceeds a threshold for a site of the selected sites.   
     
     
         13 . The non-transitory computer storage medium of  claim 12 , wherein:
 the factors associated with the selected sites are country-dependent and time-dependent.   
     
     
         14 . A computer system for managing a clinical trial, the system comprising:
 a processor;   an output device;   a computer memory storing, for each of a plurality of sites, factors impacting a rate of patient enrollment;   computer storage medium encoded with computer executable instructions, that when executed, perform a method comprising:
 computing a projected patient enrollment timeline at each of a plurality of sites based on factors in the computer memory associated with each of the plurality of sites; 
 computing a monitor workload timeline based on the projected patient enrollment timeline; 
 generating and outputting instructions for a monitor to review performance of the clinical trial at the one or more selected sites based in part on the computed monitor workload at the one or more selected sites exceeding a threshold; and 
 providing an outcome projection for the clinical trial based on the reviewed clinical trial data. 
   
     
     
         15 . The computer system of  claim 14 , wherein:
 generating and outputting instructions for a monitor to review performance of the clinical trial at the one or more selected sites is further based in part on a passage of time since a review at the one or more selected sites.   
     
     
         16 . The computer system of  claim 14 , wherein the method further comprises:
 displaying a user interface on the output device indicating, for at least one geographic region, a difference between a planned number of monitor visits to sites in the geographic region and the actual number of monitor visits.   
     
     
         17 . The computer system of  claim 14 , wherein:
 the method further comprises receiving through a user interface entries indicating patient retention in each of a plurality of treatment intervals of the clinical trial; and   computing the projected patient enrollment timeline at each of a plurality of sites is based at least in part on received entries.   
     
     
         18 . The computer system of  claim 14 , wherein:
 the computer system comprises a smartphone comprising a user interface; and   outputting instructions for a monitor to review performance of the clinical trial at the one or more selected sites comprises providing the instructions through the user interface of the smart phone.   
     
     
         19 . The computer system of  claim 14 , wherein:
 the computer member stores factors for each of the plurality of sites that are country-dependent and time-dependent.   
     
     
         20 . The computer system of  claim 14 , wherein:
 providing the outcome projection for the clinical trial comprises providing a projection of whether the clinical trial will achieve a recruitment goal.