Proposed changes to Pharmaceutical research for application of a new drug

Order Description principal focus is Australia and the role of the TGA Secondary focus is the US and the role of the FDA. Purpose - Both TGA and FDA have a particular model of Phased (tiered) research, see https://www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials BUT its generally accepted that this model is overly costly and time consuming. Both the TGA and FDA have over the past 10 years considered changes to this model - 1/. what are those changes? 2/. was any facet of the recommendation for change, incorporated into that current phased trial agenda? 3/. what changes have been proposed, and subsequently failed, why? 4/. What are both agencies attitude towards simulated trial data? its use for drug registration? and its ability to potentiate really world likeness? 5/. What are the agencies attitude to the collect of big data from multiple trial sources?