NHMRC to establish national clinical trials register

The National Health and Medical Research Council (NHMRC) is to spend AUD$1.5 million to establish a national clinical trials register.

Trials entered on the register will range from those researching new drugs and treatments to new and/or improved surgical procedures and medical devices.

"The register will increase collaboration, improve awareness and make it easier to find clinical trials," said Davina Ghersi, director of systematic reviews and healthcare assessment at the NHMRC Clinical Trials Centre in Sydney.

The register will help researchers identify gaps in their own research or prevent unnecessary duplication of clinical trials and provide researchers with new insights by having access to information about trials underway in Australia.

People will be able to find out where research is happening -- for example, a woman with breast cancer can find out about trials of new therapies for the disease. The register could include consumer or lay summaries with "different interpretations of a trial so that people are not put off by medical jargon," said Ghersi.

"[The register] will continue to evolve as we get more feedback from stakeholders," she said.

From July 1, the International Committee of Medical Journal Editors will not publish the results of any clinical trials not included on an authorised register. At present, the only clinical trial register that meets the committee's requirements is the US National Institutes of Health register (www.clinicaltrials.gov), said Ghersi.

The European metaRegister does not comply because it charges a fee for issuing an international standard random control trial number.

Ghersi said that while it may be a year before Australia has a comprehensive register available, a short-term solution will be provided so that Australian researchers can meet the committee's requirements, with a minimum dataset established by mid-June.

A more comprehensive register should be available within a year, but it will take three years to be fully developed.

Public HIV trials register

Meanwhile, a number of specific clinical trial registries already exist in Australia. The latest is a public HIV clinical trials register, established by the University of Queensland (UQ).

"It was initially set up to inform clinicians that are working in Queensland in HIV who was doing what. It has ended up being a point of information for people with HIV," said Stephen Lambert, coordinator of UQ's School of Medicine HIV Education Program. "People with HIV don't get the full story about what's happening from their doctor, mostly because their doctor doesn't know."

Lambert said the register was receiving about six hits a day from outside the university.

He said he was aware of the NHMRC's plans for a national clinical trials register, and that ultimately he would like to see the UQ's HIV register superseded by the national one.

The HIV Clinical Trials Register is available at http://www.som.uq.edu.au/hivandhcvprojects/hiv/hiv_clinical_trials_register.shtml