Systems and methods for drug development

Abstract

Systems and methods are provided for drug development under a fully transparent development model. The model is configured to provide transparency to the patients, the researchers, clinicians, physicians, and any other registered users of the system who wish to contribute. According to various embodiments, the system and model enable drug development that leverage the combined wisdom and insight of the user population eliminating many of the drawbacks of conventional development approaches. In one embodiment, the system includes drug development engine configured to manage execution of parameters of a clinical trial, including collection of health and treatment information from a patient population. The development engine can publish collected execution data for review and analysis.

What is claimed: 
     
         1 . A drug development system implementing a transparent clinical trial protocol development model, the system comprising:
 at least one processor operatively connected to a memory, the at least one processor when executing provides:
 a protocol builder subsystem for open clinical trial protocol creation, wherein the protocol builder subsystem provides for interactive real time input of a plurality of participants including at least clinicians or physicians and potential patients to create at least a portion of a clinical trial protocol for testing one or more drugs, that once defined can be used to test the one or more drugs on patients during subsequent execution of a complete clinical trial protocol, wherein the protocol builder subsystem is configured to:
 display a first user interface configured to:
 accept a first user request for protocol development to create the at least the portion of the clinical trial protocol; 
 create the at least the portion of the clinical trial protocol, which can be used to test the one or more drugs on patients during subsequent execution of a complete clinical trial, wherein the protocol builder subsystem is configured to define parameters of the at least the portion of the clinical trial protocol responsive to interactive input from users including at least clinicians or physicians and potential patients, wherein the users collectively define, modify, and accept the parameters; and 
 display modifications to clinical endpoints, inclusion criteria, exclusion criteria, dosing, and data analysis responsive to receiving the plurality of submissions; 
 
 display a second user interface configured to register a plurality of users for access to a curated environment, wherein the plurality of users include at least clinicians or physicians and potential patients to increase a knowledge base associated with protocol development, wherein the second user interface is further configured to provide access to at least one protocol development project over a communication network, wherein each respective one of the at least one protocol development project defines criteria for executing the at least the portion of the clinical trial protocol, and wherein a complete clinical trial protocol represents the collection of aspects of a scientific experiment for testing the one or more drugs with human subjects; 
 finalize the criteria for executing the at least the portion of the clinical trial based on the interactive input; and 
 communicate the finalized criteria for executing the at least the portion of the clinical trial protocol to a drug development subsystem. 
 
   
     
     
         2 . The system according to  claim 1 , further comprising the drug development subsystem comprising a drug development engine configured to:
 manage execution of the finalized parameters of the clinical trial protocol created and communicated via the protocol builder subsystem;   receive, via a communication interface, remote trial execution data from patient monitoring devices operating according to at least one parameter of the clinical trial protocol;   control execution of the patient monitoring devices according to the finalized criteria for executing the at least the portion of the clinical trial protocol communicated by the communication interface;   accept user input regarding the at least the portion of the remote trial execution data;   alter at least one parameter defined for executing the clinical trial protocol responsive, at least in part, to the user input and remote trial execution data; and   update control and execution of the patient monitoring devices according to the alterations made to the at least one parameter defined for executing the clinical trial based upon communicating the updates over the communication interface to the patient monitoring devices.   
     
     
         3 . The system according to  claim 1 , wherein the protocol builder subsystem is configured to generate survey questions presented to the plurality of registered users to define at least one parameter of the clinical trial protocol. 
     
     
         4 . The system according to  claim 3 , wherein the survey questions are configured to solicit answers, wherein the system determines a consensus from the answers to define patient priorities regarding clinical endpoints for execution of the clinical trial protocol. 
     
     
         5 . The system according to  claim 2 , wherein the protocol builder subsystem is configured to publish the at least the portion of the remote trial execution data for review on the drug development system during execution of the clinical trial protocol. 
     
     
         6 . The system according to  claim 2 , further comprising an analysis component configured to aggregate the remote trial execution data to generate at least a portion of the remote trial execution data. 
     
     
         7 . The system according to  claim 2 , further comprising a storage component configured to store remote trial execution data with an associated patient. 
     
     
         8 . The system according to  claim 2 , wherein the drug development engine is configured to display the remote trial execution data associated with the patient to the patient responsive to authentication. 
     
     
         9 . The system according to  claim 2 , wherein the drug development engine is configured to accept user submissions regarding at least a portion of the remote trial execution data. 
     
     
         10 . The system according to  claim 9 , wherein the drug development engine is configured to publish the user submissions regarding the at least the portion of the remote trial execution data. 
     
     
         11 . The system according to  claim 10 , further comprising an analysis component configured to identify indicators for altering at least one parameter defined for the clinical trial responsive, at least in part, to the user submissions. 
     
     
         12 . The system according to  claim 11 , wherein the analysis component is configured to identify indicators for terminating the execution of the clinical trial early responsive, at least in part, to one or more of the user submissions and the remote execution data. 
     
     
         13 . A drug development system implementing a transparent clinical trial protocol development model, the system comprising:
 at least one processor operatively connected to a memory, the at least one processor when executing provides:
 a protocol builder subsystem for open clinical trial protocol creation, wherein the protocol builder subsystem provides for interactive real time input of a plurality of participants including at least clinicians or physicians and potential patients to create at least a portion of a clinical trial protocol for testing one or more drugs, that once defined can be used to test the one or more drugs on patients during subsequent execution of a complete clinical trial protocol, wherein the protocol builder subsystem is configured to:
 display a first user interface configured to:
 create the at least the portion of the clinical trial protocol, responsive to interactive input from users including at least clinicians or physicians, and potential patients wherein the users collectively define, modify, and accept the parameters; 
 
 display a second user interface configured to register a plurality of users for access to a curated environment, wherein the plurality of users include at least clinicians or physicians and potential patients to increase a knowledge base associated with protocol development, wherein the second user interface is further configured to provide access to at least one protocol development project over a communication network, wherein each respective one of the at least one protocol development project defines criteria for executing the at least the portion of the clinical trial protocol, and wherein a complete clinical trial protocol represents the collection of aspects of a scientific experiment for testing the one or more drugs with human subjects; 
 finalize the criteria for executing the at least the portion of the clinical trial based on the interactive input; and 
 communicate the finalized criteria for executing the at least the portion of the clinical trial protocol to a drug development subsystem. 
 
   
     
     
         14 . The system according to  claim 13 , wherein the user interface is configured to accept user submissions regarding the at least the portion of the remote trial execution data. 
     
     
         15 . The system according to  claim 14 , wherein the user interface is configured to publish the user submissions regarding the at least the portion of the remote trial execution data. 
     
     
         16 . The system according to  claim 15 , further comprising an analysis component configured to identify indicators for altering at least one parameter defined for the clinical trial, responsive, at least in part to the user submissions. 
     
     
         17 . The system according to  claim 16 , wherein the analysis component is configured to identify indicators for terminating the execution of the clinical trial early responsive, at least in part, to one or more of the user submissions and the remote execution data. 
     
     
         18 . A computer implemented method for transparent drug development, the method comprising:
 displaying a first user interface and, via the first user interface:
 creating, by at least one processor, at least a portion of a clinical trial protocol, for testing one or more drugs or a use of the one or more drugs, responsive to receiving interactive input from users including at least clinicians or physicians and potential patients, wherein the users collectively define, modify, and accept parameters of the clinical trial protocol; 
   displaying a second user interface and, via the second user interface:
 registering a plurality of users for access to a curated environment, wherein the plurality of users include at least clinicians or physicians and potential patients to increase a knowledge base associated with protocol development; and 
 providing access to at least one protocol development project over a communication network, wherein each respective one of the at least one protocol development project defines criteria for executing the at least the portion of the clinical trial protocol, and wherein a complete clinical trial protocol represents the collection of aspects of a scientific experiment for testing the one or more drugs with human subjects; 
   finalizing, by the at least one processor, the criteria for executing the at least the portion of the clinical trial protocol based on the interactive input; and   communicating the finalized criteria for executing the at least the portion of the clinical trial protocol to a drug development subsystem.   
     
     
         19 . The method according to  claim 18 , further comprising:
 receiving, by a communication interface of the drug development subsystem, remote trial execution data from patient monitoring devices;   controlling, by the drug development subsystem, execution of the patient monitoring devices according to the finalized criteria for executing the at least the portion of the clinical trial protocol communicated by from the protocol builder subsystem;   accepting, by the drug development subsystem, user input regarding the at least the portion of the remote trial execution data;   altering, by the drug development subsystem, at least one parameter defined for executing the clinical trial protocol responsive, at least in part, to the user input and remote trial execution data;   updating, by the drug development subsystem, control and execution of the patient monitoring devices according to the alterations made to the at least one parameter defined for executing the clinical trial protocol; and   identifying indicators for terminating the execution of the clinical trial protocol early responsive, at least in part, to analyzing one or more user submissions and the remote trial execution data.