A government report says that clinical trials for new medicines are taking too long and should be sped up so patients can access urgently needed treatment. The states and territories have been urged to adopt uniform rules on approving trials so the scientific experiments can be conducted more efficiently and effectively.
The Clinical Trials Action Group report says the time taken to complete trials was “becoming increasingly lengthy”. It has also called on the National Health and Medical Research Council to make information on existing clinical trials more accessible and more regular. Links should also be made with other existing trials. Overall reforming the clinical trial scenario would give patients faster access to potential new treatments, the report said. The report was commissioned in October 2009.
The report found that clinical trials are worth around $1 billion to the Australian economy each year, including around $450 million of foreign investment with Australia attracting trials from around the world. However, the very increase in popularity of trials has placed a heavy burden on the infrastructure to approve, manage and monitor trials.
The report recommends a streamlined and nationally standardized ethical approval process that based on the National Health and Medical Research Council’s (NHMRC) Harmonisation of Multi-centre Ethical Review (HoMER) scheme. This would mean that a trial conducted at more than one center would need a single ethical approval. To hasten approvals, trial operators can pay an additional fee to have trials approved within 30 calendar days, with a standard maximum of 60 days for governance and ethical approvals.
The report also makes a commitment to a single nationalized standard for how clinical trials receive governance approval according to NHMRC guidelines. The cost of clinical trial approval will also be standardized across private and public organizations with the fee based on cost recovery principles rather than a blanket higher fee for privately run trials.
The government will also make an effort to better integrate clinical trials with e-health technologies, including patient records and data collection. The report also recommends a new central web portal along the lines of the US’s clinicaltrials.gov website for prospective trial patients to find out information about all trials being run in Australia and better facilitating patient recruitment. The NHMRC will also work to improve communication and collaboration between institutions academia and trial providers to help promote trials that serve an unmet medical need.
Federal Health Minister Nicola Roxon has agreed to adopt the report recommendations. “The changes that will occur will boost pharmaceutical research and development and improve the clinical trials approval process,” she said. Various government departments would work to implement all the reports recommendations, she assured. Innovation Minister Senator Kim Carr also voiced support of the report. The Clinical Trials Action Group is an initiative of the Pharmaceutical Industry Working Group which is co-chaired by Ms Roxon and Senator Carr.
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