Patent Document ID: 9747424
Application ID: 13751413
Patent Flag: 1

Claim One:
1. A drug development system implementing a transparent clinical 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 configured to: display a user interface configured to: accept a first user request for protocol development to create at least the portion of the clinical trial protocol; prompt the first user to specify a disease, one or more drugs, and a treatment regimen for the one or more drugs to be tested; accept input of an overview of the protocol requested; display prompts for first user input of any known objective for the protocol; wherein the protocol builder subsystem is further configured to: identify, responsive to submission of the request for protocol development, for inclusion in the request review criteria to evaluate responsive submissions to the request for protocol development; identify for inclusion in the request for protocol development, testable targets during and at a completion of the protocol for the treatment regimen, including a measureable baseline and treatment characteristics, and further including: dependent and independent variables for the protocol; a relationship between the independent and dependent variables; or a change in the independent variable and an effect on the dependent variable; publish the request for protocol development for review by the plurality of users; create at least a portion of a clinical trial for testing at least one drug or a use of the at least one drug, the at least one portion once defined, can be used to test the at least one drug on patients during subsequent execution of a complete clinical trial and wherein the complete clinical study protocol represents a collection of aspects of a scientific experiment for testing the at least one drug with human subjects, wherein the protocol builder subsystem is configured to define parameters of at least the portion of the clinical trial responsive to interactive input from users including at least clinicians or physicians and potential patients to increase a knowledge base associated with protocol development, wherein the at least the clinicians or physicians and the potential patients define, accept, and modify the parameters of the clinical trial for testing one or more drugs; present candidate parameters through the user interface for acceptance by the users including at least the clinicians or the physicians and the potential patients; the user interface being further configured to: receive a plurality of submissions regarding the candidate parameters, including at least analysis by potential patients of any member of a group or combination of members of the group comprising: clinical endpoints, inclusion criteria, exclusion criteria, dosing, and data analysis used to create at least the portion of the clinical trial, and wherein the plurality of submissions confirm, modify, and define the at least one aspect of the clinical trial for the at least one drug; display, within the interface, the plurality of submissions from the plurality of users for subsequent review responsive to receipt of the plurality of submissions; display modifications to the clinical endpoints, inclusion criteria, exclusion criteria, dosing, and data analysis responsive to receiving the plurality of submissions; wherein the protocol builder subsystem is further configured to resolve the plurality of submissions from the users received regarding the candidate parameters to define the parameters and criteria for evaluating the parameters of the clinical trial; finalize, responsive to resolving the plurality of submissions, the criteria for executing the at least the portion of the clinical trial; and wherein the protocol builder subsystem is configured to publish the input within the interface, including the clinical endpoints, the inclusion criteria, the exclusion criteria, the dosing, and the data analysis, finalized parameters, and finalized criteria for the parameters of the clinical trial for subsequent execution of the clinical endpoints, inclusion criteria, exclusion criteria, dosing, and data analysis; and a drug development subsystem comprising a drug development engine configured to manage execution of the finalized parameters of the clinical trial created and communicated via the protocol builder subsystem, wherein the drug development engine includes: a collection component configured to: receive, via a communication interface, remote trial execution data from patient monitoring devices according to at least one parameter of the clinical trial; control execution of the patient monitoring devices according to the finalized criteria for executing the at least the portion of the clinical trial communicated by the communication interface; receive, via a communication interface, at least health and treatment information from a patient population defined for the clinical trial wherein members of the patient population are associated with at least one patient monitoring device; wherein drug development subsystem is further configured to associate members of the patient population with physical patient monitoring devices for issuance; a user interface configured to publish at least a portion of the trial execution data received from the patient monitoring devices for review on the drug development system, and wherein the user interface is further configured to: accept user input regarding the at least the portion of the trial execution data; publish, within the interface, the user input regarding the at least the portion of the trial execution data; and wherein the drug development subsystem is further configured to: alter at least one parameter defined for executing the clinical trial 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.