The federal government in Australia needs to maintain the momentum of its efforts to reinvigorate the nation’s clinical trial base, insists the local association for research-based pharmaceutical companies.

Medicines Australia is keeping up the pressure on government to deliver on its promise of implementing the recommendations earlier this year of the Clinical Trials Action Group (CTAG), a panel set up to look at ways of arresting the decline in clinical trial activity in Australia.

“The CTAG plan represents a precious opportunity to help restore Australia’s international reputation as a centre of excellence for clinical trials,” said Dr Brendan Shaw, chief executive of Medicines Australia, as the industry association launched a paper on Keeping clinical trials in Australia: why action is needed at Parliament House in Canberra.

“We are making some progress towards that but it’s critical that we don’t drop the ball,” Shaw commented.

Annual decline

The paper shows that the number of new clinical trials in Australia has been declining over the past three years by an average of 13 per cent per annum.
As Medicines Australia points out, the introduction in 1991 of the Therapeutic Goods Administration’s (TGA) Clinical Trial Notification (CTN) Scheme simplified the regulation of trials and allowed companies and researchers to start them much more quickly.

As a result, the number of clinical studies conducted in Australia increased dramatically, but more recent years have seen this trend reverse. From a peak of 3,182 clinical trial notifications in 2006/2007, according to TGA data, the volume dropped to 2,792 in 2007/8, recovered to 2,986 notifications in 2008/9, but declined again to 2,916 in 2009/10 and 2,820 in 2010/11.

Strengths and weaknesses

A SWOT analysis undertaken in May 2008 by the Pharmaceuticals Industry Strategy Group identified a number of industry strengths in relation to clinical trials in Australia, the Medicines Australia paper notes.

These include a high-quality infrastructure; an ethnically diverse population; a high volunteer rate; a fast-track approval system for Phase I trials; globally recognised clinicians; and strong intellectual property laws.

But the analysis also highlighted weaknesses such as a small and geographically dispersed population (i.e., fewer patients per trial site); a limited capacity to supply patients in some therapeutic areas, due to the number of ongoing trials; significantly higher costs for Phase II and III trials than in emerging markets; and inefficiencies such as multicentre clinical trials requiring approval from each institution involved.

Competition from abroad

Australian companies are facing increasing competition for trials from India, China, Brazil and emerging markets in Eastern Europe, the paper adds.

These countries are attracting a larger share of global clinical trial investment because they have much larger patient populations, significant cost advantages, skilled labour and increasingly sophisticated healthcare systems that can produce quality trial data.

Yet Australia has not moved quickly enough to address this challenge, the paper says. Clinical trial ethics and governance review processes, for example, remain “slow and inefficient”.

In October 2006, the Australian Health Ministers’ Advisory Committee recommended that Australia implement a national system in which there would be a single ethical review of multi-centre clinical trials, Medicines Australia observes.

More than five years later, “there is still no national system in place. There are single ethics review processes now in place in New South Wales, Victoria and Queensland within each of those states. Nevertheless, sponsor companies must still obtain an ethics approval from each state as well as in each institution in every other state where the trial will be conducted”.

The three eastern states recently signed a Memorandum of Understanding enabling a single ethical review of a multicentre trial for public health institutions across those states, the paper notes. But this does not include private hospitals or universities, which will still require a separate ethics review.

CTAG recommendations

Submitted to ministers in June 2010 and published on 2 March 2011, the CTAG’s report on raising Australia’s profile as a destination of choice for clinical trials recommended:

•    Speeding up ethics and governance review
•    Providing for cost recovery of efficient clinical trials
•    Ensuring trials can take advantage of Australia’s developing e-health system
•    Improving patient recruitment
•    Facilitating better national co-ordination and greater collaboration across clinical trial networks
•    Improving reporting and monitoring of the value and performance of clinical trials

The implementation of those recommendations “presents many challenges for industry, government and researchers alike”, the Medicines Australia paper says.

Not only is the timeframe for implementation demanding, but many of the recommendations call for different stakeholders “to engage beyond their primary policy imperatives”, it observes.
One such example is the recommendation that the National E-Health Transition Authority (NEHTA), as well as the state and territorial governments, make the clinical research system a key consideration when designing, developing and implementing e-health standards, specifications, strategies, frameworks, systems and programmes.

This will enable more efficient monitoring of patients who have agreed to participate in clinical trials and allow enrolment of patients from more remote locations, Medicines Australia points out.

To date, though, “this has not been a key consideration for NEHTA. Accommodating clinical trials when the e-Health project is already well advanced is likely to be challenging”.

“We boast some of the world’s best clinical research scientists and state-of-the-art clinical research infrastructure,” Dr Shaw commented. “But Australia can only capitalise on that advantage by continuing to implement the Government’s clinical trials plan.”