Researchers initiating clinical trials in Australia must attend to trial design, resource issues, ethics review, regulatory oversight, institutional policies, research governance and many other issues. Information on ethics processes, principles of research conduct, regulatory considerations and research governance are found in this section of the website.
NHMRC have developed learning modules on the Australian clinical trials environment, ethical issues related to clinical trials and governance relevant to clinical trials. Whether you are a researcher, in a research office or just wanting to find out more about how clinical trials are conducted, these modules use interactive learning, interviews with experts and knowledge reviews to provide an overview of the nature and importance of the clinical trials environment and approval process in Australia.
There are numerous considerations that should be made when planning a clinical trial – some of these are as follows:
Clinical trial design
- What is the exact research question this clinical trial is intended to answer?
- What is the primary outcome variable? Is this readily measured?
- Is it a direct measure of outcome or do you intend to rely on surrogate endpoints?
- Are these outcomes those specified by guidance documents as the preferred measures for the outcome of interest? (This of particular relevance if you intend the trial to be part of a marketing submission; see European Union Guidelines adopted in Australia).
- Is the trial design appropriate?
- Are subject numbers or event numbers sufficient to give adequate statistical power to detect a difference in treatments should one exist, or demonstrate non-inferiority (i.e. can the trial answer the proposed research question or will the data be equivocal)? (This aspect of design represents a genuine ethical consideration undertaken by Human Research Ethics Committees and needs professional statistical consideration).
- Have you considered the ongoing treatment of trial subjects should they respond to the unapproved medical product under investigation? Building in a trial extension provision into the original protocol design not only fulfils Good Clinical Practice (GCP) requirements but also can allow such treatment to continue without having to put together another trial proposal after the initial trial ceases. Of course, this is not the only way to provide ongoing treatment post-trial, but is a point to consider in the planning process.
Participant and staff numbers and resources
- Are your trial centre(s) likely to be able to provide an adequate number of participants for the trial?
- Should the trial be extended to additional sites to ensure recruitment? (Dealing with this early on reduces the likelihood of additional CTN applications being required later on. It also works towards adequate recruitment to satisfy statistical requirements.)
- Do you have adequate resourcing, facilities and oversight of the protocol?
Some legal requirement to consider are:
- Are adequate indemnity provisions in place for the trial, including for the staff involved? Note that some indemnity cover does not include clinical trial related activities or the use of experimental treatments.
- Do participant informed consent documents contain a full description of the requirements, risks and benefits of trial participation, in plain English, such that participants can make an informed decision?
- Are the investigational products correctly labelled and packaged according to the Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme?