Integrated clinical trial design and design optimization

A method for evaluating and amending a protocol of a target clinical trial associated with a disease wherein said protocol has a plurality of parameters each having a value, comprising:

• 1) obtaining a set of inclusion and exclusion criteria of a target clinical trial associated with a disease;
• 2) transforming said criteria to a filter for filtering a master database storing patient data in historical clinical trials associated with said disease, generating a subdatabase storing filtered data;
• 3) constructing a set of baseline characteristics based on said filtered data stored in said subdatabase;
• 4) conducting a quantitative analysis by comparing said protocol to said set of baseline characteristics;
• and
• 5) making a recommendation based on said quantitative analysis;
• wherein said recommendation comprises one of the following:
• a) no protocol amendment is needed if said quantitative analysis indicates that said protocol would achieve one or more objectives of said target clinical trial;
• and
• b) a protocol amendment is needed if said quantitative analysis indicates one of the following:
• (1) at least one parameter of said protocol shall be removed or added;
• and
• (2) at least one parameter value of said protocol shall be adjusted,
• wherein said protocol amendment would help said target clinical trial achieve one or more objectives according to said quantitative analysis.