They developed a taxonomy of assessment strategies, and considered the conclusions drawn when using these differing definitions. They determined four main categories of study: Taxol 33069-62-4 “counts of new drugs approved, assessments of therapeutic value, economic outcomes and patents issued.”12 Studies based on counts of new drug approvals reported both positive and negative temporal trends in innovation, depending on the definitions used, geographical locations and time periods studied. However, studies published in the last decade that define innovativeness on the basis of therapeutic value all report a negative trend in the innovativeness of new drugs, despite using different approaches
to measurement and reporting time periods varying from 1990–2003 to 2001–2010. The varied approaches to measuring therapeutic value included: the results from premarketing and postmarketing trials; pharmaceutical or technical innovation; comparison with available marketed alternatives or therapeutic
novelty (giving greater weight to drugs for conditions with no existing effective treatment); and more general public health measures. Regardless of the approach used to measure therapeutic value, all these studies characterised only a minority of new drugs as highly innovative. Motola et al13 considered all drugs approved by the European Medicines Agency (EMA) between 1995 and 2003 according to an algorithm that considered the severity of the target indication, availability of existing treatments and size of therapeutic benefit. The authors characterised 32% of new drugs as representing important therapeutic innovation;
a figure which rose to 39% of drugs for serious conditions. A subsequent update to this work (including drugs approved to July 2004),14 characterised an even lower proportion of new drugs as important therapeutic innovations (28%); for biotechnological products, this figure was just 25%. Joppi et al15 also considered biotechnological products approved by the EMA between 1995 and 2003 and also characterised just 25% as representing therapeutic innovation on the basis of relative efficacy compared with existing treatments (including where no treatment previously existed or offering treatment to patients resistant to existing Dacomitinib therapies). Similar data from Canada found that of all new branded medicines approved between 1990 and 2003, just 6% were designated as ‘breakthrough’ on the basis of providing the first effective treatment for a patient group or substantial improvement over existing products.16 The most recent evidence on numbers of new drug launches suggests that any decline seen since the mid-1990s is now being reversed.17–20 We previously described a decline in new drug launches in the UK from 1997 to 2003, with a rise in new drug launches from 2004 onwards.