Systems and methods for drug development

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:
• create at least a portion of a clinical trial for testing at least one drug or a use of the at least one drug 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 of the clinical trial for testing one or more drugs;
• finalize the criteria for executing the at least the portion of the clinical trial based on the interactive input;
• a drug development subsystem configured to:
• receive, via a communication interface, remote trial execution data from patient monitoring devices;
• 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 from the protocol builder subsystem;
• accept user input regarding the at least the portion of the trial execution data;
• 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.

A computer implemented method for transparent drug development, the method comprising:

• creating, by at least one processor, at least a portion of a clinical trial for testing at least one drug or a use of the at least one drug responsive to receiving interactive input from users including at least clinicians or physicians, and potential patients wherein the users collectively define, modify, and accept the parameters of the clinical trial for testing one or more drugs;
• finalize, by the at least one processor, the criteria for executing the at least the portion of the clinical trial based on the interactive input;
• a drug development subsystem configured to:
• receiving, by the at least one processor, a communication interface, remote trial execution data from patient monitoring devices;
• controlling, by the at least one processor, execution of the patient monitoring devices according to the finalized criteria for executing the at least the portion of the clinical trial communicated by from the protocol builder subsystem;
• accepting, by the at least one processor, user input regarding the at least the portion of the trial execution data;
• altering, by the at least one processor, 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
• updating, by the at least one processor, 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.

A drug development system implementing a transparent clinical protocol development model, the system comprising:

• a protocol builder subsystem for open clinical study protocol creation wherein the protocol builder system 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 for testing one or more drugs, that once defined can be used to test the drug on patients during subsequent execution of a complete clinical trial, wherein the protocol builder subsystem comprises:
• at least one processor operatively connected to a memory;
• a first user interface, executed by the at least one processor, 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 measurable 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;
• 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 clinical trial and wherein a complete clinical study protocol represents the collection of aspects of a scientific experiment for testing the one or more drugs with human subjects;
• a challenge generation component configured to identify candidate challenges for protocol development, wherein each candidate challenge is configured to define at least one aspect of the clinical trial for a drug;
• an evaluation component configured to present candidate challenges for acceptance, wherein the evaluation component is further configured to receive approval for at least some of the candidate challenges;
• wherein the second user interface is further configured to:
• execute iterative development of candidate challenges, the execution including requests for responses from the users including at least clinicians or physicians and potential patients, wherein the responses confirm, modify, or define the at least one aspect of the clinical trial for a drug associated with a candidate challenge;
• accept a plurality of submissions from the plurality of users in response to presentation of the candidate challenges and the requests for responses;
• display the plurality of submissions from the plurality of users for review by subsequent users responsive to receipt;
• display modifications to the candidate challenges responsive to receiving the plurality of submissions;
• and
• wherein the protocol builder subsystem is further configured to:
• finalize, using the at least one processor, for each respective one of the at least one protocol development project, the criteria for executing at least a portion of the clinical trial responsive to review information received and responses to the candidate challenges based on at least the review information received, the modifications to the candidate challenges, and any other responses to the candidate challenges;
• communicate the finalized criteria for executing at least a portion of the clinical trial protocol to a drug development subsystem.