Risk management in medicines evaluation; lessons learned from software development
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Increasing pressure is put on the current pharmaceutical regulatory field. Demands for quicker patients’ access to drugs are in contrast with the need for reliable information regarding the benefit and risk of pharmaceutical products. Therefore evaluation of drug research, regulation and prescription is ongoing. In order to evaluate the drug regulatory process, a comparison is made between software development and pharmaceutical product regulation. In software development, evolution of the traditional ‘waterfall’ development model, by user demand, has resulted in ‘incremental’, ‘spiral’ and ‘agile’ models along with the radical change seen in open source software development. Two aspects most evolved in these software development models are early market access and user feedback. Translation of these aspects to the pharmaceutical regulatory field would result in a regulatory pathway of experimental early market access. However, we think implementation of such a new regulatory pathway should not be persued at the moment, in the light of current uncertainty about the possible increased safety risk and ethical considerations regarding the early availability of these medicines. We think further research should clearify these issues before experimental early market access can be beneficial for the pharmaceutical regulatory field.