US 7,970,550 B2Granted

Interactive technique for optimizing drug development from the pre-clinical phases through phase-IV

AssigneeOptimata Ltd.

InventorsLevon Arakelyan, Vera Selitser, Zvia Agur

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Abstract

A method of performing interactive clinical trials for testing a new drug. A pre-clinical phase is performed in which a computer model for pharmacokinetics and pharmacodynamics of the drug is created and adjusted based on in vitro studies and in vivo studies in animals. A phase I clinical research is performed in which a clinical trial on at least a single dose is performed in parallel with performing computer simulation studies using the computer model. An optimal protocol is determined for the most responsive patient populations and indications for a phase II clinical trial. Phase II clinical trial is performed where a number of small scale clinical trials are performed in parallel based on results of the above. Phase III clinical research is performed for chosen indications by chosen protocols. Phase IV studies are performed for post-marketing subpopulation analysis and long term product safety assessment.

A method of performing interactive clinical trials for testing a new drug for cancer related studies, resulting in clinical trial designs, the method comprising:

a) performing a pre-clinical phase in which a computer model for pharmacodynamics of a drug is determined;
b) obtaining data to determine the computer model for the pharmacodynamics of the drug of (a) from in vitro studies of the effect of the drug in animal cells, and optionally, in vivo studies in animals, and obtaining data for the pharmacokinetics of the drug of (a) from in vivo studies in animals;
c) performing a phase I clinical trial in which a clinical trial on at least a single dose of the drug of (a) is administered to at least one human, and the phase I clinical trial is performed in parallel by performing computer simulations using the computer model constructed in step (a);
d) adjusting the computer model based on comparison of the results of the clinical trial and computer simulations using the computer model, wherein the at least a single dose of step (c) is incrementally increased in at least one dose escalation step;
e) calculating the dose escalation step by the computer simulations performed using the computer model in step (d) to obtain a maximal tolerated dose, minimum effective dose, and a recommended dose;
f) checking the patient for cumulative drug effects after administration and providing this information to the computer model;
g) performing multiple simulations using the computer model with different doses and dosing intervals for different indications and patient populations;
h) determining, based on step (g) simulations results, an optimal regimen for the most responsive patient populations and clinical indications for a phase II clinical trial;
i) performing at least one phase II clinical trial where a number of small scale clinical trials are performed in parallel in order to test the optimal treatment regimen from step (h) for different pairs of clinical indications and patient populations;
j) performing at least one phase III clinical trial for a clinical indication chosen in step (h) using a regimen that was chosen in step (i);
and
k) performing at least one phase IV clinical trial, based on, at least, one previous clinical trial, for post-marketing subpopulation analysis that may identify differences in efficacy and toxicity between the subpopulations, and long term product safety assessment.

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Facts

Application

10/662,345Filed 16 Sep 2003 · us provisional application

Priority

16 Sep 2002

Published

US 2004/0107084 A13 Jun 2004

Granted

28 Jun 2011

Term ends

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Classification5 codes

G16H 50/50
ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or…: for…
G16C 20/30
Chemoinformatics, i.e. ICT specially adapted for the handling of physicochemical or structural data of chemical particles, elements, compounds…
G16H 10/20
ICT specially adapted for the handling or processing of patient-related medical or healthcare data: for electronic clinical trials or questionnaires
G16H
Healthcare informatics, i.e. information and communication technology [ict] specially adapted for the

Abstract

Claims21