Clinical trial phase simulation method and clinical trial phase simulator for drug trials

A technology for clinical trials, simulation methods, used in electronic clinical trials, computer-aided drug prescription/delivery, medical simulation, etc.

Inactive Publication Date: 2007-06-06
BRACCO IMAGINIG SPA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Therefore, it cannot be said that the forecasts made are very reliable

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  • Clinical trial phase simulation method and clinical trial phase simulator for drug trials
  • Clinical trial phase simulation method and clinical trial phase simulator for drug trials
  • Clinical trial phase simulation method and clinical trial phase simulator for drug trials

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Embodiment Construction

[0071] The method involved in the present invention is explained below through two experiments.

[0072] Both experiments were performed using the same starting database, generated using a database of Phase III trials with known and established outcomes on known drugs. The initial database is generated to simulate Phase II trial database. Also, from each group, select the reduced number of individuals that make up the group. The choice was made to provide results of this trial that did not lead to a clear indication of the efficacy of the drug being tested, contrary to the results of Phase III trials, which had shown that the drug was effective for the The disease has a clear curative effect.

[0073]A typical phase 2 trial scenario is thus constructed whereby the phase 2 trial does not give a clear indication of the efficacy of the drug being tested, when in fact the drug is effective.

[0074] The experimental database used as the basis for constructing the simulated pha...

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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; carrying 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.

Description

technical field [0001] The invention relates to a method for simulating the clinical trial period of a drug test, which can predict the trend of the drug clinical trial period results. Background technique [0002] Before a new drug or biological product is released on the market, it needs to be tested. Testing is done by way of clinical trials. Clinical trials consist of three phases. In the first phase, the drug is tested on healthy volunteers. If the results are positive, a phase 2 clinical trial is conducted, in which the drug is tested on a limited number of patients for which the drug is believed to be effective for the disease. At this stage, patients were divided into three groups. Two of the three groups were treated with a different kind of placebo or with an existing drug. People in the remaining group were treated with the drug to be tested. [0003] In the third phase, a clinical test is carried out on a very large number of volunteers. [0004] The cost ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G06F19/00
CPCG06F19/3456G06F19/3437G16H10/20G16H50/50
Inventor P·M·布谢马E·格罗西
Owner BRACCO IMAGINIG SPA
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