Early Phase Trials Best Practice Toolkit
Timeline: Q1, 2019 – Q4, 2019.
Issue: There is currently no single source of best practice outlining expectations for the conduct of Early Phase clinical trials in Australia.
Purpose: Increased assurance on safety and performance of Early Phase clinical trials in Australia
Objectives: ID broadly, summarise & test recommendations for best practice conduct of Early Phase clinical trials.
- National & international environment scan & literature review.
- Qualitative analysis: Survey &/or interview relevant stakeholders.
- Host Expert Meeting to define Australian Best Practice to define minimum site standards.
- Road test minimum standards at a variety of sites.
- Literature review providing summary of international guidance.
- Best practice guidance recommendations.