Methods and apparatus for data-driven monitoring

Abstract

Methods and apparatus for facilitating monitoring in a clinical trial. The method includes acts of receiving data from at least one information technology system configured to process clinical trial data, and assigning a site prioritization to each of a plurality of sites for at least one clinical trial associated with the at least one information technology system. Assigning a site prioritization is based, at least in part, on the received data. The method further includes an act of outputting an indication of the site prioritization.

What is claimed is: 
     
         1 . A method of facilitating monitoring in a clinical trial, the method comprising:
 receiving data from at least one information technology system configured to process clinical trial data;   assigning, using at least one processor, a site prioritization to each of a plurality of sites for at least one clinical trial associated with the at least one information technology system, wherein the assigning a site prioritization is based, at least in part, on the received data; and   outputting an indication of the site prioritization.   
     
     
         2 . The method of  claim 1 , further comprising:
 receiving criteria for a clinical trial and/or a clinical trial sponsor, wherein the criteria includes at least one workload task and/or at least one risk indicator; and   wherein assigning a site prioritization is further based, at least in part, on the criteria.   
     
     
         3 . The method of  claim 2 , wherein the criteria includes at least one workload task, and wherein the method further comprises:
 determining a workload for each of the plurality of sites based, at least in part, on the data received from at least one information technology system associated with the at least one workload task.   
     
     
         4 . The method of  claim 3 , further comprising:
 outputting, via a user interface, an indication of the workload determined for one or more of the plurality of sites.   
     
     
         5 . The method of  claim 3 , wherein determining a workload for at least one of the plurality of sites comprises:
 assigning a time component to each task of the at least one workload task;   determining a total workload time for each task of the at least one workload task for the site, wherein the determining a total workload time is based, at least in part, on the assigned time components and the data received from at least one information technology system associated with a corresponding task of the at least one workload task for the site; and   determining a total workload for the site is based, at least in part, on the total workload time for each task of the at least one workload task for the site.   
     
     
         6 . The method of  claim 2 , wherein the criteria includes at least one risk indicator, and wherein the method further comprises:
 determining a risk score for each of the plurality of sites based, at least in part, on the data received from at least one information technology system associated with the at least one risk indictor; and   wherein assigning a site prioritization based, at least in part, on the criteria comprises assigning the site prioritization for each of the plurality of sites based, at least in part, on a corresponding risk score determined for the site.   
     
     
         7 . The method of  claim 6 , further comprising:
 outputting, via a user interface, an indication of the risk score determined for one or more of the plurality of sites.   
     
     
         8 . The method of  claim 2 , wherein determining a risk score for at least one of the plurality of sites comprises:
 grouping the plurality of risk indicators into risk factors by generating a score for each of at least a portion of the plurality of risk indicators;   determining a risk score for each risk factor; and   determining the risk score for the site based, at least in part, on the risk scores for each of the risk factors.   
     
     
         9 . The method of  claim 8 , wherein the risk factors include a risk factor selected from the group consisting of patient safety, protocol adherence, site issues, and data quality. 
     
     
         10 . The method of  claim 2 , wherein the at least one risk indicator includes a risk indicator selected from the group consisting of a screening failure rate, an adverse event reporting rate, an absence of reported adverse events, a concomitant medication reporting amount, a number of reported serious adverse events, a number of protocol deviations, a number of site issues, and a data entry correction amount. 
     
     
         11 . The method of  claim 2 , wherein the criteria includes at least one workload task and at least one risk indicator, and wherein assigning a site prioritization based, at least in part, on the criteria comprises:
 determining a workload score for a site based, at least in part, on the data received from at least one information technology system associated with the at least one workload task;   determining a risk score for the site based, at least in part, on the data received from at least one information technology system associated with the at least one risk indicator; and   assigning the site prioritization for a site based, at least in part, on the workload score for the site and the risk score for the site.   
     
     
         12 . The method of  claim 2 , wherein the criteria further includes at least one trigger factor selected from the group consisting of a serious adverse event, a reported protocol deviation, and an emergency code break; and
 wherein assigning a site prioritization is further based, at least in part, on the at least one trigger factor.   
     
     
         13 . The method of  claim 2 , wherein the criteria further includes an indication of whether work can be performed remote from a site, and wherein assigning a site prioritization based, at least in part, on the criteria comprises assigning the site prioritization based, at least in part, on the indication of whether work can be performed remote from a site. 
     
     
         14 . The method of  claim 2 , wherein receiving the criteria comprises receiving the criteria via at least one user interface. 
     
     
         15 . The method of  claim 2 , wherein receiving the criteria comprises programming at least one processor with the criteria. 
     
     
         16 . The method of  claim 1 , wherein assigning a site prioritization is further based, at least in part, on a geographic location of a site. 
     
     
         17 . The method of  claim 1 , further comprising:
 sending a request to the at least one information technology system to provide the data; and   wherein the receiving data from at least one information technology system comprises receiving the data from the at least one information technology system in response to sending the request.   
     
     
         18 . The method of  claim 1 , wherein the at least one information technology system includes at least one system selected from the group consisting of an electronic data capture (EDC) system, a clinical trial management system (CTMS), a randomization and trial supply management (RTSM) system, a medical imaging system, an ECG management system, an electronic patient reported outcomes system, a drug safety system, and a central laboratory data system. 
     
     
         19 . The method of  claim 1 , wherein assigning a site prioritization to each of a plurality of sites for at least one clinical trial comprises assigning a site prioritization to each of a plurality of sites for at least two clinical trials associated with the at least one information technology system. 
     
     
         20 . The method of  claim 1 , wherein outputting an indication of the site prioritization comprises displaying, on a user interface, an output visualization with which a user may interact to perform at least one task. 
     
     
         21 - 27 . (canceled)