Paul Komesaroff, Monash University; Colin Thomson, University of Wollongong, and Ian Kerridge, University of Sydney
CLINICAL TRIALS – Human clinical trials are an important last hurdle in the development of new drugs and therapies. Today, The Conversation takes a closer look at this vital scientific endeavour with three articles that look at different aspects of the process.
Testing new drugs in clinical trials is a billion-dollar industry in Australia, with most of the money coming from international pharmaceutical companies. But as investment grows in India, China, and other emerging competitors, some people argue we need to make Australia more attractive to such investment. One of their solutions is to water down the ethics approval process.
Responding to these concerns, the Coalition’s election policy on medical research promises to “move swiftly” with reforms to the ways in which clinical trials are conducted, by developing:
a nationally consistent approach to ethical standards to reduce complexity, speed up the process and where possible, rationalise the number of ethics committees to reduce the large number that currently exist.
Before major changes are introduced, however, it is important to remember that ethics committees are the very bodies that ensure the safety of clinical trials and maintain public confidence.
Developed in response to concerns about the untrammelled power of medical institutions in the 1970s, as well as reports of egregious excesses by researchers in the United States and elsewhere, the ethics committee system has become highly refined in both its processes and in the substance of the issues it addresses.
In Australia, it is also remarkably devolved and democratic, drawing in thousands of men and women from different walks of life across the country to engage in conversation, for no personal gain, about ethical issues in health care and research.
Established by hospitals and universities, the panels review research proposals and ensure they’re ethically acceptable. Their deliberations cover potential risks and benefits to both individuals and the wider society and issues relating to consent, confidentiality, privacy, conflicts of interest and protection of vulnerable participants. Continue reading