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.
