Research – Proposed changes to Pharmaceutical research for application of a new drug

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Research – Proposed changes to Pharmaceutical research for application of a new drug

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principal focus is Australia and the role of the TGA

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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 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.

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