Systems and methods for improved assessment and reporting of the efficacy and safety of drug, biologic, botanical, vitamin, medical food and medical device treatments
First Claim
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1. A method for improved assessment of medical treatment of disease, comprising:
- obtaining from a subject one or more measurements of the effects of said medical treatment;
selecting at least one physiologic state during which said measurements are taken; and
determining based on said measurements the safety and efficacy of said medical treatment.
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Abstract
A system and method are described to identify risks and assess the efficacy and safety associated with drug, biologic, nutritional, medical food and medical device therapies throughout the treatment development process. The data measured are evaluated in relation to a patient'"'"'s specific physiologic state (for example, data collected throughout a biological cycle) to determine the attribution to specific organ systems, functions or mechanisms, and are reported within this context. Further, the system and method enable real time access and entry of patient data stored in a centralized database via the internet or other computing device.
38 Citations
28 Claims
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1. A method for improved assessment of medical treatment of disease, comprising:
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obtaining from a subject one or more measurements of the effects of said medical treatment;
selecting at least one physiologic state during which said measurements are taken; and
determining based on said measurements the safety and efficacy of said medical treatment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A system for centralized assessment of treatment development program data, comprising:
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at least one development program server comprising at least one development program database and assessment analysis software module operative to analyze treatment development program data stored in the at least one development program database;
at least one development program site located at a secure network location and including at least one site device for collection of development program data; and
a communications link providing communication between the at least one development program server and the at least development program site. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A method for improved assessment of medical treatment of disease, comprising:
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obtaining from a subject one or more measurements of the effects of said medical treatment;
selecting at least one physiologic state during which said measurements are taken;
providing a secured network site device for a user to input measurements from said subject;
establishing a communications link between the site device and a central database;
transferring the measurements to said central database;
analyzing the measurements; and
determining based on said measurements the safety and efficacy of said medical treatment. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification