In order to obtain results that are clearer to interpret, clinical trials are often performed within a rigid phase framework (from Phase I to Phase IV) in groups of people that are very similar to each other but there can be scientific reasons why these are sometimes not the same as the people who are most likely to take the medication once it is on the market. New, more flexible approaches to drug development must be explored because the current model does not work well for all diseases1. All approaches take as a given that safety and quality standards are maintained.
As we develop medicines in increasingly complicated therapeutic areas, new approaches may be more appropriate such as:
1The Lancet, Volume 375, Issue 9712, Pages 357–359, 30 January 2010
2The future of drug development: advancing clinical trial design. Nat Rev Drug Discov. 2009 Dec;8(12):949-57. Epub 2009 Oct 9