Aernoud Fiolet

375 Clinical implications and future perspectives research programs. Changing current patent rules is probably essential to this. Extending or redefining the patent possibilities makes it more attractive to enclose such research efforts in the company’s portfolio. Of course, this comes with the important societal notion that if a product is shown to be efficacious, excessive repricing of the drug should be averted. Al these efforts contribute to enabling research on drug repurposing. However, to bring any of these results to the patient, the final step is to guarantee translation of such research to a product dossier that can be submitted to international drug agencies, together with endorsement by clinical guidelines Nature Reviews | Drug Discovery a Overall trend in R&D efficiency (inflation-adjusted) Number of drugs per billion US$ R&D spending* 0.1 1.0 10 100 1950 1960 1970 1980 1990 2000 2010 FDA tightens regulation post-thalidomide First wave of biotechnology- derived therapies FDA clears backlog following PDUFA regulations plus small bolus of HIV drugs Figure 4. Overall trend in efficiency of research and development of drugs. The number of new drugs approved by the United States (US) Food and Drug Administration (FDA) per billion US dollars (adjusted for inflation) spent on research and development has halved roughly every 9 years. Adapted from Scannell et al. 30 Abbreviations: FDA, United States (US) Food and Drug Administration. HIV, human immunodeficiency virus. PDFUA, Prescription Drug User Fee Act. R&D, research and development. Secondly, investigators should rethink methods of data collection. The majority of data collection is still done manually and based on the properties of old-fashioned medical systems, in which all parameters have to be (re)collected using physical investigator-patient interviews. In Chapters 13 and 14 , we have shown that much of the effort of recruiting patients could be spared by using automatic screening systems. In fact, routinely collected clinical data can be used ith high levels of accuracy for the purpose of scientific research. These results are irrespective of electronic health care record system and can be used for cross-sectional baseline