Research - 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? The purpose of the paper is to define a potentially better way of conducting this type of medical research reducing costs and time, but still being efficacious and allowing for potential drug registration. Key outcomes: 1/. highlight what has been demonstrated, if accepted, what was it, if not accepted, what was it and why? 2/. areas of focus are 1. TGA and 2. FDA 3/. This paper only requires a minor review of the phased research program. No more than 5 pages! 4/. a questionnaire designed for Government and industry stakeholders to determine other acceptable ways to conduct research for drug registration - questionnaire must be validated against a source. Questionnaire must aim to demonstrate, safety and efficacy of the trial mechanism, ways to minimise costs and time.