Method and system for increasing the efficacy of a clinical trial
First Claim
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1. A method for increasing the efficacy of a clinical trial, the method comprising the steps of:
- (a) obtaining information regarding a clinical trial participant;
(b) configuring a clinical trial compliance system according to the parameters of a clinical trial protocol and information obtained regarding the clinical trial participant;
(c) activating the clinical trial compliance system; and
(d) transmitting a plurality of clinical trial compliance messages to the clinical trial participant, whereby a clinical trial investigator obtains information regarding a clinical trial participant, a clinical trial compliance system is configured according to the parameters of a clinical trial protocol and the information obtained regarding the clinical trial participant, the clinical trial compliance system is activated to transmit a plurality of clinical trial compliance reminders to the clinical trial participant, and a plurality of clinical trial compliance messages is transmitted to the clinical trial participant by the clinical trial compliance system.
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Abstract
The present invention provides a method and system for increasing the efficacy of a clinical trial, whereby a plurality of clinical trial compliance messages are transmitted to a clinical trial participant so that the clinical trial participant may more closely adhere to the parameters of a clinical trial protocol.
74 Citations
53 Claims
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1. A method for increasing the efficacy of a clinical trial, the method comprising the steps of:
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(a) obtaining information regarding a clinical trial participant;
(b) configuring a clinical trial compliance system according to the parameters of a clinical trial protocol and information obtained regarding the clinical trial participant;
(c) activating the clinical trial compliance system; and
(d) transmitting a plurality of clinical trial compliance messages to the clinical trial participant, whereby a clinical trial investigator obtains information regarding a clinical trial participant, a clinical trial compliance system is configured according to the parameters of a clinical trial protocol and the information obtained regarding the clinical trial participant, the clinical trial compliance system is activated to transmit a plurality of clinical trial compliance reminders to the clinical trial participant, and a plurality of clinical trial compliance messages is transmitted to the clinical trial participant by the clinical trial compliance system. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A method for increasing the efficacy of a clinical trial, the method comprising the steps of:
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(a) obtaining information regarding a clinical trial participant;
(b) configuring a clinical trial compliance system according to the parameters of a clinical trial protocol and information obtained regarding the clinical trial participant;
(c) activating the clinical trial compliance system;
(d) transmitting a plurality of clinical trial compliance messages to the clinical trial participant;
(e) requesting or obtaining a response of the clinical trial participant to the clinical trial compliance message;
(f) storing a clinical trial participant'"'"'s response to a clinical trial compliance message; and
(g) attempting to retain a clinical trial participant upon the failure of the clinical trial participant to respond as directed to a clinical trial compliance message, whereby a clinical trial investigator obtains information regarding a clinical trial participant, a clinical trial compliance system is configured to generate a schedule of clinical trial reminder messages to be transmitted to the clinical trial participant, where the content of and intervals between clinical trial reminder messages are determined according to the parameters of a clinical trial protocol and the information obtained regarding the clinical trial participant, the clinical trial compliance system is activated to transmit a plurality of clinical trial compliance reminders to the clinical trial participant, a plurality of clinical trial compliance messages is transmitted to the clinical trial participant by the clinical trial compliance system, the clinical trial participant is requested to respond to the clinical trial compliance message or a response is obtained by a clinical trial participant to the clinical trial compliance message, a response by the clinical trial participant to a clinical trial compliance message is stored for later analysis, and an attempt is made by the clinical investigator to retain a clinical trial participant upon the failure of the clinical trial participant to respond as directed to a clinical trial compliance message.
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34. A clinical trial compliance system for increasing the efficacy of a clinical trial, comprising:
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(a) a data storage unit capable of storing information regarding a clinical trial participant, a clinical trial investigator and a clinical trial protocol;
(b) a main central processing unit operably linked to the data storage unit, wherein the main central processing unit comprises at least one program to (i) store information regarding a clinical trial participant, (ii) store information regarding a clinical trial investigator, (iii) store information regarding a clinical trial protocol, (iv) generate a clinical trial compliance message according to the parameters of the clinical trial protocol, and (v) transmit the clinical trial compliance message according to a schedule determined by the parameters of the clinical trial protocol;
(c) a telecommunications system operably linked to the main central processing unit, and (d) a message unit operably linked to the telecommunications system, wherein the message unit allows the clinical trial participant to receive clinical trial compliance messages transmitted by the main central processing unit. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. A clinical trial compliance system for increasing the efficacy of a clinical trial, comprising:
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(a) a data storage unit capable of storing information regarding a clinical trial participant, a clinical trial investigator and a clinical trial protocol;
(b) a main central processing unit operably linked to the data storage unit, wherein the first central processing unit comprises at least one program to (i) store information regarding a clinical trial participant, (ii) store information regarding a clinical trial investigator, (iii) store information regarding a clinical trial protocol, (iv) generate a clinical trial compliance message according to the parameters of the clinical trial protocol, (v) transmit the clinical trial compliance message according to a schedule determined by the parameters of the clinical trial protocol, and (vi) decode and store responses by the clinical trial participant to a clinical trial compliance message;
(c) a telecommunications system operably linked to the main central processing unit;
(d) a message unit operably connected to the telecommunications system, wherein the message unit allows the clinical trial participant to both receive clinical trial compliance messages transmitted by the main central processing unit and to transmit responses to the clinical trial compliance messages, where the responses to the clinical trial compliance messages are transmitted via the telecommunications system to the main central processing unit; and
(e) a contact unit of the clinical trial investigator operably connected to the telecommunications system, wherein the contact unit allows the clinical trial investigator to receive messages from the main central processing unit in the event that the clinical trial participant fails to respond as directed to a clinical trial compliance message.
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Specification