Clinical trials are carefully designed research studies that investigate a new medical test or treatment for people. Trials may look at whether a treatment is safe and its side effects, or how well a treatment or procedure works. Some trials look at how well treatments control symptoms or whether they improve quality of life.
Important stakeholders in clinical trials
There are 3 main stakeholders involved in developing, conducting and reporting on a clinical trial – sponsors, investigators and ethics committees. These stakeholders work together to ensure the safety of the participants and the scientific rigour of the research.
Sponsors
The sponsor is responsible for the overall ethical and safe conduct of the trial. The term sponsor does not necessarily refer to the body that funds the research. But, in some cases, the sponsor may also be the funding body.
The sponsor signs contracts, sets up the study and manages it in accordance with guidelines and legislature. They ensure that:
- the studies are well designed and run according to guidelines
- staff involved in the research are qualified and appropriately trained
- the participants are safe.
Investigators
The investigator is responsible for:
- getting ethics approval
- gaining appropriate informed consent from potential participants
- administering the intervention to trial participants
- collecting the trial data
- reporting adverse reactions to the treatment under investigation
- reporting to the sponsor on the conduct of the trial at the site.
In drug and medical trials, the investigator is the treating clinician (the participant’s doctor). In clinical trials groups, the responsibilities of the investigator often sits with a few roles:
- the lead researcher (also known as the principal investigator)
- the study management team
- the study coordinator or the research assistant.
Ethics committees
The ethics committee assesses human research against the standards outlined in relevant regulations and guidelines. They also assess whether the risks to the participants resulting from the research are justified by the potential benefits. Human research cannot proceed without approval from the ethics committee.
Australian universities, local health districts and some research institutes have their own ethics committees. A research project usually must be cleared by all of the participating sites’ ethics committees. This means that if the same trial is run in multiple local health districts and hospitals, each site’s committee must approve the study.
How clinical trials are funded
Clinical trials are expensive to run. There are costs associated with the medicines, matching placebo (if relevant), medical devices, operations, imaging and training. The transport, storage and dispensing of the treatment are also expenses.
In Australia, patients are not responsible for any of the costs. Trial costs are covered by, for example:
- government organisations such as the National Health and Medical Research Council (NHMRC) or the Medical Research Future Fund (MRFF)
- universities, which provide PhD scholarships, post-doctoral fellowships, career development awards and other research fellowships
- non-government cancer organisations
- commercial companies, which may provide full or part funding, or trial medication and devices
- fundraising, which may be led by established institutes that engage in community-based fundraising.
Many trials will be funded by more than one source.
How clinical trials are governed in Australia
Australia has various laws, guidelines and entities to ensure that clinical trials research is conducted ethically and effectively. These laws and guidelines apply to any research involving human subjects, not just for drug or medical intervention trials.
National Health and Medical Research Council (NHMRC)
The National Health and Medical Research Council (NHMRC) supports and advises on funding for medical research.
The NHMRC published the National Statement on Ethical Conduct in Human Research 2023, which is a series of guidelines that align with the National Health and Medical Research Council Act 1992. The statement outlines the responsibilities of institutions and researchers for the ethical design, conduct and dissemination of results of human research, as well as the responsibilities of review bodies in the ethics review of research.
The NHMRC also published the Australian Code for the Responsible Conduct of Research 2018, which establishes a framework for responsible research conduct. The framework provides a foundation for high-quality research, credibility and community trust in the research endeavour.
Researchers in Australia must follow the National Statement on Ethical Conduct in Human Research 2023 and the Australian Code for the Responsible Conduct of Research 2018.
Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) regulates medical products, including drugs and medical devices. The TGA’s the Australian Clinical Trial Handbook and guidance on unapproved therapeutic goods sets out the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.
Therapeutic Good Act 1989
The Therapeutic Goods Act 1989 and its associated documents set out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. These requirements cover advertising, labelling, product appearance and appeal guidelines of therapeutic goods listed in the Australian Register of Therapeutic Goods (ARTG).
Organisational policies
Each organisation that engages in human research will also have their own organisational policies. For example, they may have standard operating procedures regarding disciplines for specific clinic trials and study protocols specifically written for each trial or research study.
