Critical Analysis of a Journal Article Article Review by Top Papers

The paper discusses how Jacobson-Kram and Mills (2008) rely almost entirely on the FDA and maintain that the success of phase 0 trials depends on how well they are guided by the FDA. The paper notes that the authors also use various studies as evidence, and the main argument is about the potential of phase 0 trials since they can reduce costs and lead to improvements in new drugs. The paper explains that the two obstacles to drug development are high costs and risks to patients, and based on the FDA, it is argued that phase 0 studies could speed up the development of drugs and other products. The paper discusses how market entry is made easier by phase 0 trials so that new therapies can be made available, costs are reduced compared to starting with phase 1 studies, and with less need for pharmacology or toxicology testing, costs are decreased and the study process is short.