Patent Document ID: 20040107084
Application ID: 10662345
Patent Flag: 0

Claim One:
1. A method of performing interactive clinical trials for testing a new drug comprising: a) performing a pre-clinical phase 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; b) performing a phase I clinical research in which a clinical trial on at least a single dose is performed in parallel with performing computer simulation studies using the computer model; c) adjusting the computer model based on comparison of the results of the clinical research and the computer simulation; d) determination of a maximal tolerated dose, minimum effective dose, and a recommended dose based on the phase I clinical research in conjunction with the computer simulations; e) checking the drug for cumulative effects and providing this information to the computer model; f) performing multiple simulations using the computer model with different doses and dosing intervals; g) determining an optimal protocol for the most responsive patient populations and indications for a phase II clinical trial; h) performing phase II clinical trial where a number of small scale clinical trials are performed in parallel based on results of step g; i) analyzing interim results to choose the most promising regimens for continued clinical trials; j) performing phase III clinical research for chosen indications by chosen protocols; and k) performing phase IV studies for post-marketing subpopulation analysis and long term product safety assessment.