Why do companies conduct clinical trials?

In brief, clinical trials are a regulatory requirement before a new drug, device or procedure can achieve registration -- a complex process determined by a country's regulatory agency. Registration that allows the use of a new therapy in humans is dependent on the submission to such agencies such as the US Food and Drug Administration and Australia's Therapeutic Goods Administration, of considerable evidence to supports the conclusion that the new therapy is safe and effective.

What does an organisation have to do to conduct a clinical trial?

In Australia, research involving humans can only be undertaken after the detailed design of the study has been scrutinised by, and received approval from, a human research ethics committee, or HREC. An important component of the application to the HREC is the information that will be provided to potential participants and will form the basis of their informed consent to join the trial.

Who can participate in a clinical trial?

Each trial design includes detailed information about who is eligible (and who is ineligible) for inclusion. A trial may specify a number of different selection criteria that potential participants must meet, such as age, sex, severity of target disease and medical history. The selection criteria must be approved as part of the application to an HREC.

What are the advantages of participating in a clinical trial?

Perhaps the best reason is that clinical trials are the necessary forerunner to new drugs and therapies. In addition, participation in a clinical trial is often associated with the best in clinical care, as patients are monitored closely over the course of the trial. Participants are likely to benefit from a successful outcome by being offered continuation of the treatment after the trial or commencement of treatment if they received placebo throughout the trial.

Potential participants should be aware that involvement in a clinical trial does not mean that they will receive a new and promising treatment. They may be allocated to the control group that receives no active treatment, or a group that receives the existing best available treatment.

What risks are associated with participation in a clinical trial?

Any risks will vary from trial to trial and should be clearly spelt out in the information provided to potential participants before they give their informed consent to enrol in the trial.

Where can information be found about what clinical trials are under way?

The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online register of all clinical trials involving Australian/New Zealand researchers or participants being undertaken in Australia and New Zealand. All of the information is publicly available at http://www.anzctr.org.au/.

For trials taking place in the US, the U.S. National Institutes of Health provide information on clinical trials at http://www.clinicaltrials.gov/.