2. Clinical Trials in Australia

2. Clinical Trials in Australia

[Start of recorded material]

Introduction

Each country and jurisdiction has the right to develop specific guidelines and legislation to guide clinical research. Australian authorities have developed a range of laws and guidelines relevant to clinical research. We will discuss these in brief but recommend you familiarise yourself with these documents.

Transition

Guidelines and Legislation

Click on the boxes to find out about the different rules in Australia.

-Medical Research Endowment Fund

In Australia the regulation of human research began with the Medical Research Endowment Fund Act in 1937. The Commonwealth Parliament had established the Medical Research Endowment Fund. Responsibility for the Fund was vested in the Minister for Health who could determine its use for medical research and in the training of persons in medical research, acting on the advice of the National Health and Medical Research Council, which was constituted in 1936.

-Statement on Human Experimentation

In 1966 the Council issued the Statement on Human Experimentation that expressly drew on the Declaration of Helsinki. It outlined the ethical principles that guide the conduct of human experimentation, in particular how the rights of human subjects are to be protected. In 1972 a review committee was convened to revise the Statement. Their report and recommendations were handed down in 1976 and included a supplementary note to the original Statement explicitly requiring institutional ethical review of research be obtained. It was amended to explicitly state coverage of all human research - medical, social and behavioural.

-Therapeutic Goods Act and Registration

In 1989 the Australian government passed the Therapeutic Goods Act which sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods.

-Governance

So how are clinical trials governed in Australia? There are three tiers of clinical trials governance. The Australian legislation underpinning the legal governance of clinical trials is contained in two main documents - the Therapeutic Goods Act 1989 and its associated documents – which set out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia, and the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling, product appearance and appeal guidelines, Access to Unapproved Therapeutic Goods in Australia 2004 which sets out the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial. It is primarily directed at sponsors and investigators, but will also provide useful guidance to Human Research Ethics Committees.

There are also three guideline documents which researchers in Australia are required to follow. The first is the International Guidelines, the ICH-GCP annotated with comments from the Therapeutics Goods Administration;the NHMRC National Statement on Ethical Conduct of Research in 2007, which in Australia supersedes the ICH-GCP section on ethics; the Australian Code for Responsible Conduct of Research 2007. It is worth noting that even though these documents were specifically written for drug or medical intervention trials, it is generally accepted that the principles apply to any research involving human subjects.

[audio cuts out] the legislation and the guidelines, each organisation which engages in human research will 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.

-National Statement on Ethical Conduct of Research

The 1999 National Statement addressed many issues not discussed in the previous version, or issues discussed in less detail. It was a response to the request for clearer guidance for those conducting research and those involved in its ethical review without compromising the protection of participants. The revised National Statement provided greater flexibility in the practice of ethical review depending on the type and area of research and the degree of risk involved.

Research often involves public interaction between people that serves a public good. There is, therefore, a public responsibility for seeing that these interactions are ethically acceptable to the Australian community. That responsibility is acknowledged and given effect in the wide-reaching authority of this National Statement which sets out national standards for the ethical design and review of conduct in human research. Its content reflects the outcome of wide consultation with Australian communities who participate in design, conduct, fund, manage and publish human research.

-Australian Clinical Trials Handbook

In 2006 the TGA released the Australian Clinical Trials Handbook intended to be a simple, practical guide to conducting clinical trials to international good clinical practice standards in the Australian context.

-Access to Unapproved Therapeutic Goods

In 2004 the Therapeutic Goods Administration released the document, Access to Unapproved Therapeutic Goods and Clinical Trials, in Australia which are the regulations allowing patients access to unapproved medicines or medical devices via participation in a clinical trial. The changes reflected amendments to the Therapeutic Goods Act, particularly the inclusion of medical devices. The Clinical Trial Notification, or CTN, scheme and the Clinical Trial Exemption scheme, or CTX scheme, continued to operate governing access to therapeutic drugs and devices not yet included on the Australian Register of Therapeutic Goods.

-Australian Code of Responsible Research

The Australian Code for the Responsible Conduct of Research was developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia in 2007. The Code has broad relevance across all research disciplines. It replaces the National Health and Medical Research Council and Australian Vice-Chancellors Committee statement and guidelines on research practice developed in 1997. The two main parts of this Code detail the principles and practices encouraging responsible conduct of research, as well as a framework for resolving allegations of misconduct in research. It is a Code governing the practice of research for individual researchers as well as institutions involved in research.

Resources

[End of recorded material]

- 1 -