Before new drugs, vaccines, devices or treatments can be introduced onto the market, they must be tested systematically on human volunteers to ensure that they are both safe and effective. These clinical trials are divided into four standard phases, three of which take place before permission to manufacture is granted. For the purposes of international comparison, by convention, clinical trial phases 1, 2, and 3 can be treated as R&D. Phase 4 clinical trials, which continue testing the drug or treatment after approval and manufacture, should only be treated as R&D if they bring about a further scientific or technological advance. Moreover, not all activities undertaken prior to permission to manufacture are considered to be R&D, especially when there is a significant wait after the completion of phase 3 trials, during which activities related to marketing and process development may be started.
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