By Uwe Amann
In the years 1996 to 2003 the number of NMEs approved by the FDA thus halved, while the research expenditure in the same period almost doubled. Only roughly one in 5000 researched substances can be developed into a new drug.
At the same time scientists are confronted not only with financing problems, but also with increasing security requirements imposed by the authorities, triggered last but not least by frequently occurring undesired effects of preparations that have been market launched.
The recall of the COX2 inhibitors Vioxx is cited as a current example. The high security requirements and the compulsion to achieve consistent data increase the complexity of clinical studies though. More studies and studies with a higher number of participants are required, which in turn can lead to longer development times.