Pharmacokinetic, quality of life and pharmacoeconomic studies can be designed as add-on or as free standing clinical studies.

Golden rules help a company decide where they are in terms of standards and where they want to be. Golden rules also provide a path to help guide changes toward the goals.

Consider the degree of extrapolatability of every clinical trial and every pre-clinical experiment designed. For example, it is generally desirable to use strict inclusion criteria in Phase 2 to obtain a fairly homogeneous and narrow patient population, whereas in Phase 3 it is usually the opposite. Thus, large Phase 3 trials include patients with other diseases, other drugs and other types of medical status to enable the sponsor to be able to extrapolate the data to a greater proportion of the entire patient population to be treated.

Zero based inclusion criteria means that each protocol starts with a tabular rosa. Only those criteria that are essential are added. Each criterion is kept as broad and least restrictive as necessary (e.g.,age limits).