To start a clinical trial in Australia you need to consider a range of issues, including:
- trial design
- resource issues
- ethics review
- regulatory oversight
- institutional policies
- research governance.
Clinical trial design
Things you need to consider when designing a clinical trial:
- What is the exact research question you want to answer?
- What is the primary outcome variable? How will you measure it?
- Is it a direct measure of outcome or will you rely on surrogate endpoints?
- Are these measures specified by guidance documents as the preferred measures for the outcome of interest? This applies if the trial will be part of a marketing submission – see the Therapeutic Goods Administration’s list of European Union Guidelines adopted in Australia.
- Is the trial design appropriate?
- Will the trial clearly answer the proposed research question or will the data be ambiguous? Human research ethics committees will carefully evaluate this as part of their ethics review, so it needs professional statistical consideration.
- You must consider the ongoing treatment of any trial participants who respond to the intervention you’re testing. This is one way to meet Good Clinical Practice (GCP) requirements and it means treatment can continue after the initial trial ends.
Participant and staff numbers and resources
Consider these questions when planning trial numbers and resources:
- Will your trial centres provide enough participants for the trial?
- Do you include extra trial sites to make sure you have enough participants? Dealing with this early on means you’re
- more likely to meet statistical requirements
- less likely to need extra Clinical Trial Notification scheme applications later on.
- Do you have enough resourcing, facilities and oversight of the protocol?
Some legal requirements to consider:
- Do you have enough indemnity and insurance cover for the trial, including for the staff involved? Some indemnity cover does not include clinical-trial-related activities or the use of experimental treatments. Read the National Health and Medical Research Council's report on indemnity and insurance arrangements for clinical trials.
- Does your Participant Information and Consent Form contain a full description of the requirements, risks and benefits of trial participation? These can be in plain English, to help participants make an informed decision.
- Have you labelled and packaged the interventions you’re testing in line with the Pharmaceutical Inspection Co-Operation Scheme?
For more information on conducting clinical trials in Australia, read the