Systems and methods for drug development
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.
1. A drug development system implementing a transparent clinical trial protocol development model, the system comprising:
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 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 the at least the portion of the clinical trial protocol;
prompt a 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; and
publish the request for protocol development for review by the plurality of users,
wherein the protocol builder subsystem further comprises:
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;
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 protocol 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 protocol 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 the at least the portion of the clinical trial protocol 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; and
communicate the finalized criteria for executing at least a portion of the clinical trial protocol to a drug development subsystem.
2. The drug development system according to claim 1 , wherein the second user interface includes a registration component configured to register the plurality of users, which include at least patients and trial investigators.
3. The drug development 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 drug development 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 drug development 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 drug development system according to claim 2 , further comprising an analysis component configured to aggregate remote trial execution data.
7. The drug development system according to claim 2 , further comprising a storage component configured to store remote trial execution data with an associated patient.
8. The drug development system according to claim 2 , wherein the drug development subsystem is configured to display remote trial execution data associated with the patient to the patient responsive to authentication.
9. The drug development system according to claim 2 , wherein the drug development subsystem is configured to accept user submissions regarding at least a portion of remote trial execution data.
10. The drug development system according to claim 9 , wherein the drug development subsystem is configured to publish the user submissions regarding the at least the portion of the remote trial execution data.
11. The drug development 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 drug development 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.