Method for integrated analysis of safety, efficacy and business aspects of drugs undergoing development

A method of distinguishing between different ways of dividing a population into dosage application subgroups for treatment with an active pharmaceutical product, the method comprising:

• providing a plurality of sets of subgroupings of said population,
• for said population obtaining economic data,
• for each subgrouping generating an economic value of providing said treatment to said subgroup,
• indexing each set according to economic values of respective subsets, and
• selecting one of said sets based on at least said indexing.

Apparatus for increasing a probability of a positive outcome of application over a population, of a pharmaceutically active product, the apparatus comprising:

• an input for receiving data including patient data of said population, and dosage data, safety result data and efficacy result data of said application,
• an analytical processor for analytically processing said data to form subgroupings within said population showing substantially similar results, thereby to arrive at a safe and efficacious dosage recommendation of said pharmaceutically active product for at least one of said subgroupings, said safe dosage level recommendation being arrived at to maximize said probability of a positive outcome, said analytical processor being able to repeat said analytical processing to provide different sets of subgroupings of said population,
• a first indexer for indexing said subgroupings according to a combination of safety and efficacy levels, and
• an index summing unit for carrying out a summation of said index over respective sets, thereby to provide a means of comparing different sets to find an optimal set.

Combination population subgroup identifier and pharmaceutical application dosage calculator comprising:

• a first input for receiving patient specific categorization data of patients in a population, said data being selected by suitability for define population subgroups with respect to said application,
• a second input for receiving applied dosage data patientwise,
• a third input for receiving efficacy result data of said application patientwise,
• a fourth input for receiving safety result data of said application patientwise,
• a processor for processing data of said inputs to define subgroups of said population showing similar result data,
• a dosage determiner for applying at least one of a safety threshold rule and an efficacy threshold rule to at least one of said subgroups to determine a safe or efficacious dosage level for said at least one subgroup, and
• and indexer for applying to said at least one subgrouping an index expressing a combination of a safety level and an efficacy level of said subgrouping.