System And Method Of Conducting In Silico Clinical Trials

Abstract

Described herein are computer systems and methods for generating, in silico, one or more virtual patients. The one or more virtual patients can be used, for example, to conduct a virtual clinical trial, such as to determine an efficacy of a therapy or medical device. The one or more virtual patients mathematically represent a physiological system in an actual patient for a health condition. Also, the one or more virtual patients can be used, for example, to determine an adverse effect from a therapy or any other deviation from a therapy, or compliance of a patient suffering from a health condition on a therapeutic protocol.

1 . A method for determining efficacy of a therapy, comprising:
 a) generating in silico a plurality of virtual patients for modeling a health condition based on data collected from a population of previously treated patients;
 wherein the collected data represents at least one measured biological response of said previously treated patients to a previously administered therapeutic regimen; 
   b) applying a simulated therapy to said virtual patients; and   c) determining one or more physiological parameters in said virtual patients in response to said simulated therapy.   
     
     
         2 . The method of  claim 1 , further comprising:
 d) adjusting said simulated therapy based on said determined one or more physiological parameters of said virtual patients;   e) applying said adjusted simulated therapy to said virtual patients; and   f) determining the one or more physiological parameters in response to said adjusted simulated therapy.   
     
     
         3 . The method of  claim 2 , further comprising repeating steps d)-f) so as to optimize said simulated therapy for application to one or more actual patients. 
     
     
         4 . The method of  claim 1 , further comprising determining whether at least one of said determined physiological parameters of at least one of said virtual patients is indicative of an adverse effect from said simulated therapy. 
     
     
         5 . The method of  claim 1 , wherein the simulated therapy includes a simulated noncompliance with a prescribed therapy. 
     
     
         6 . The method of  claim 1 , wherein the determining step further comprises determining values of said one or more physiological parameters at a plurality of times over a predetermined time interval. 
     
     
         7 . The method of  claim 6 , wherein the one or more physiological parameters comprises one or more metabolic parameters. 
     
     
         8 . The method of  claim 7 , wherein the one or more metabolic parameters comprise blood parameters and/or urine parameters. 
     
     
         9 . The method of  claim 8 , wherein the blood parameters comprise any of hemoglobin concentration and hematocrit level. 
     
     
         10 . The method of  claim 1 , wherein each of the virtual patients comprises at least one in silico model representing a physiological system. 
     
     
         11 . The method of  claim 10 , wherein the at least one model is an erythropoiesis model. 
     
     
         12 . The method of  claim 1 , further comprising applying a plurality of different simulated therapies to each of said virtual patients, determining one or more physiological parameters in said virtual patients in response to each simulated therapy, and evaluating each simulated therapy based on the corresponding physiological parameters. 
     
     
         13 . The method of  claim 1 , wherein the therapy comprises any of at least one of: a pharmacological therapy, a non-pharmacological therapy, and a combination thereof 
     
     
         14 . The method of  claim 13 , wherein the at least one pharmacological therapy comprises an anemia therapy. 
     
     
         15 . The method of  claim 14 , wherein the anemia therapy comprises administering at least one of an erythropoiesis stimulating agent (ESA), iron, a drug stimulating endogenous erythropoietin release and/or synthesis, a biosimilar, or a combination thereof. 
     
     
         16 . The method of  claim 15 , wherein the erythropoiesis stimulating agent comprises exogenous erythropoietin. 
     
     
         17 . The method of  claim 13 , wherein the one or more non-pharmacological therapies comprises a fluid therapy, a dietary therapy, an exercise therapy, an extracorporeal therapy, a radiotherapy, a therapy using sound and/or ultrasound, an electrotherapy, or a combination thereof 
     
     
         18 . The method of  claim 1 , wherein the data collected from the population of previously treated patients comprises gender, age, weight, height, ethnicity, metabolic/chemistry parameters, complete blood count, or a combination thereof. 
     
     
         19 . The method of  claim 18 , wherein the data collected further comprises medications used by the previously treated patients, past medical history data, past surgical history data or a combination thereof 
     
     
         20 . The method of  claim 19 , wherein the past medical history data comprises information regarding diabetes, blood pressure/hypertension, cancer, congestive heart failure, or a combination thereof. 
     
     
         21 - 54 . (canceled)