Clinical Trial Phase Simulation Method and Clinical Trial Phase Simulator For Drug Trials
First Claim
1. Clinical trial phase simulation method for drug trials, which method allows to predict the trend of the results of a clinical trial phase of a drug comprising the following steps:
- a) providing a database comprising for each of a certain number of individuals a predefined number of independent variables each of which corresponds to a certain clinical parameter which parameters are relevant or characteristic for describing or identifying a disease condition against which the drug to be tested is oriented and at least a further independent variable describing the specific treatment to which the individual has been subjected between at least two different treatment one with the drug to be tested and the second treatment with a placebo or with another known drug, the database comprising also for each individuals one or more dependent variables describing the effects of the said treatments observed on the individuals;
b) carrying out an input variable selection by means of an input variable selection algorithm by feeding the set of independent variables of the database to the said input variable selection algorithm;
c) adding to the independent variables selected as input variables at step b) the one or more dependent variables describing the effects of the treatments;
d) training and validating an autoassociated artificial neural network with the set of selected independent variables as input variables and with the one or more dependent variables;
e) interrogating the trained and validated autoassociated artificial neural network by inputting only the values of the variable describing one of the at least two different treatments to which the individuals has been subjected and obtaining as an output the variable values of the effectiveness of the treatment to which the inputted values of the variable of the treatment correspond according to the trained artificial neural network;
f) repeating step e) for each treatment of the at least two treatments to which the individuals has been subjected;
g) comparing the values of the variables relative to the effectiveness of the different treatments to which the individuals has been subjected which values has been determined at steps e) and f).
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Abstract
A clinical trial phase simulation method for drug trials, which method allows to predict the trend of the results of a clinical trial phase of a drug with the steps of providing a database comprising for each of a certain number of individuals a predefined number of independent variables each of which corresponds to a certain clinical parameter relevant or characteristic for a disease condition against which the drug to be tested is oriented and at least a further independent variable describing the specific treatment to which the individual has been subjected between at least two different treatments one with the said drug and the second with a placebo or with another known drug, the database comprising also for each individuals one or more dependent variables describing the effects of the said treatments; carryings out an input variable selection; adding to the independent variables selected as input variables the dependent variables describing the effects of the treatments; training and validating an artificial neural network with the selected variables as input variables and with the dependent variables; interrogating the said neural network by inputting the values of the variable describing one of the treatments and obtaining as an output the variable values of the effectiveness of the treatment to which the inputted values of the variable of the treatment correspond according to the trained artificial neural network.
51 Citations
23 Claims
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1. Clinical trial phase simulation method for drug trials, which method allows to predict the trend of the results of a clinical trial phase of a drug comprising the following steps:
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a) providing a database comprising for each of a certain number of individuals a predefined number of independent variables each of which corresponds to a certain clinical parameter which parameters are relevant or characteristic for describing or identifying a disease condition against which the drug to be tested is oriented and at least a further independent variable describing the specific treatment to which the individual has been subjected between at least two different treatment one with the drug to be tested and the second treatment with a placebo or with another known drug, the database comprising also for each individuals one or more dependent variables describing the effects of the said treatments observed on the individuals; b) carrying out an input variable selection by means of an input variable selection algorithm by feeding the set of independent variables of the database to the said input variable selection algorithm; c) adding to the independent variables selected as input variables at step b) the one or more dependent variables describing the effects of the treatments; d) training and validating an autoassociated artificial neural network with the set of selected independent variables as input variables and with the one or more dependent variables; e) interrogating the trained and validated autoassociated artificial neural network by inputting only the values of the variable describing one of the at least two different treatments to which the individuals has been subjected and obtaining as an output the variable values of the effectiveness of the treatment to which the inputted values of the variable of the treatment correspond according to the trained artificial neural network; f) repeating step e) for each treatment of the at least two treatments to which the individuals has been subjected; g) comparing the values of the variables relative to the effectiveness of the different treatments to which the individuals has been subjected which values has been determined at steps e) and f). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An apparatus for carrying out a simulated clinical virtual trial phase characterized in that
the said apparatus comprising a first virtual network formed by a computing machine and a program for the said computing machine which program forces the apparatus to work as a neural network of the autoassociative kind; -
The said network being provided with input channels each one for a variable of a certain number of variables describing relevant clinical data of patients and variables describing the treatment to which a the said certain number of patients has been submitted; The said network being also provided with a certain number of output channels each one relating to variables describing the effects of the treatments; the apparatus being also provided with means for reading the variables describing the relevant clinical data of patients and the variables relating to the kind of treatment to which the said patients has been submitted and the corresponding output variables relating to the experimentally ascertained effects of the treatments on the said certain number of patients and for adjusting the network response to the input variables in order to generate the known output variables when the input variable of the said database are fed to the input channels; Means being provided for manually inputting the variable relating to a kind of the treatment and for reading the corresponding output of the network; And means being provided for forcing the outputs of the output channels at a value corresponding to a certain effect and reading the corresponding input values of the network. - View Dependent Claims (19, 20, 21, 22, 23)
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Specification