Distributed randomization and supply management in clinical trials

Abstract

A distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory configurations for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of dispensing medication in a multi-arm clinical trial. In accordance with the method a subject identifier and a trial identifier are received from an electronic data capture system. The trial identifier indicates the multi-arm clinical trial, and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. An arm identifier is retrieved from a database based on the received subject identifier. The arm identifier indicates an arm in the multi-arm clinical trial to which the subject is assigned. Thereafter, treatment is determined for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial. The treatment includes a set of one or more units of at least one article type.

1 . A method of dispensing medication in a multi-arm clinical trial, the method comprising:
 receiving a subject identifier and a trial identifier from an electronic data capture system, the trial identifier indicating the multi-arm clinical trial, the subject identifier indicating a subject enrolled in the multi-arm clinical trial;   retrieving an arm identifier from a database based on the received subject identifier, the arm identifier indicating an arm in the multi-arm clinical trial to which the subject is assigned; and   determining treatment for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial, the treatment including a set of one or more units of at least one article type.   
     
     
         2 . The method of  claim 1 , further comprising transmitting the set of one or more units to the electronic data capture system. 
     
     
         3 . The method of  claim 1 , further comprising:
 uploading a batch of units of article types, the batch indicating units of article types available for shipment; and   receiving an indication that one or more units of the at least one article type have been received and are available at a trial site associated with the subject identifier.   
     
     
         4 . The method of  claim 3 , further comprising determining whether there are sufficient units of the at least one article type for the treatment at the trial site for the subject identifier that comply with dispensation metrics in the treatment design. 
     
     
         5 . The method of  claim 1 , wherein the subject identifier and the trial identifier are received from a dispense custom function of the electronic data capture system. 
     
     
         6 . A system to dispense medication in a multi-arm clinical trial, the system comprising:
 a computing device; and   a machine-readable medium comprising instructions that, when executed by the computing device, cause the computing device to perform operations comprising:
 receiving a subject identifier and a trial identifier from an electronic data capture system, the trial identifier indicating the multi-arm clinical trial, the subject identifier indicating a subject enrolled in the multi-arm clinical trial; 
 retrieving an arm identifier from a database based on the received subject identifier, the arm identifier indicating an arm in the multi-arm clinical trial to which the subject is assigned; and 
 determining treatment for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial, the treatment including a set of one or more units of at least one article type. 
   
     
     
         7 . The system of  claim 6 , wherein the operations further comprise transmitting the set of one or more units to the electronic data capture system. 
     
     
         8 . The system of  claim 6 , wherein the operations further comprise:
 uploading a batch of units of article types, the batch indicating units of article types available for shipment;   receiving an indication that one or more units of the at least one article type have been shipped and are available at a trial site associated with the subject identifier.   
     
     
         9 . The system of  claim 8 , wherein the operations further comprise determining whether there are sufficient units of the at least one article type for the treatment at the trial site for the subject identifier that comply with dispensation metrics in the treatment design. 
     
     
         10 . The system of  claim 6 , wherein the subject identifier and the trial identifier are received from a dispense custom function of the electronic data capture system. 
     
     
         11 . A machine-readable storage medium comprising operational instructions that, when executed by a processor, cause the processor to perform operations comprising:
 receiving a subject identifier and a trial identifier from an electronic data capture system, the trial identifier indicating a multi-arm clinical trial, the subject identifier indicating a subject enrolled in the multi-arm clinical trial;   retrieving an arm identifier from a database based on the received subject identifier, the arm identifier indicating an arm in the multi-arm clinical trial to which the subject is assigned; and   determining treatment for the arm identifier based on a treatment design previously configured for the multi-arm clinical trial, the treatment including a set of one or more units of at least one article type.   
     
     
         12 . The machine-readable storage medium of  claim 11 , wherein the operations further comprise transmitting the set of one or more units to the electronic data capture system. 
     
     
         13 . The machine-readable storage medium of  claim 11 , wherein the operations further comprise:
 uploading a batch of units of article types, the batch indicating units of article types available for shipment; and   receiving an indication that one or more units of the at least one article type have been received and are available at a trial site associated with the subject identifier.   
     
     
         14 . The machine-readable storage medium of  claim 13 , wherein the operations further comprise determining whether there are sufficient units of the at least one article type for the treatment at the trial site for the subject identifier that comply with dispensation metrics in the treatment design. 
     
     
         15 . The machine-readable storage medium of  claim 11 , wherein the subject identifier and the trial identifier are received from a dispense custom function of the electronic data capture system.