Opinion: Why Australia should be proud of its clinical trial industry

I am sure when Mark Twain uttered those famous words he wasn’t thinking about the state of the Australian clinical trial industry. However, if we are to believe all of the doom and gloom surrounding Australia’s international standing in this industry as written in various media, then we could be forgiven for wondering if he was.

Australia has traditionally been a key contributor to large pharma, global phase III–IV studies over the years. Indeed, one might suggest that it was our success in attracting such studies that contributed to the implementation of the Clinical Trial Notification (CTN) scheme.

Ironically, perhaps it was the very success of the CTN scheme in making Australia an attractive location for clinical research, and the corresponding increase in the number of studies conducted here, that has led to the perceived loss of international standing because of start-up delays and congestion in the Human Research Ethics Committee (HREC) system.

But is our international reputation really that damaged? The answer to that depends where you stand, and it is important that we recognise that there are as many places to stand and view our industry as there are sectors and sub-sectors within it.

The view from my ‘hill’, being that of the early phase clinical trial service sector, is that Australia should be very proud of its international reputation in this sector, and this is demonstrated by the tremendous growth in the number of phase I-II studies conducted here since 2004/2005 on the back of new EU directives.

The increasing number of investigational new drug (IND) and clinical trial applications (CTAs) being submitted by sponsors utilising phase I data generated in Australia is also evidence of a healthy sector.

Underlying this is the growth in the number of phase I units, early phase patient groups/networks and specialist contract research organisations, such as CPR Pharma Services and Clinical Network Services (CNS), that are dedicated to supporting early phase research.

It is interesting to note that while HRECs are being identified as a source of bottlenecks for late phase studies, other than ongoing delays in ethics approvals in NSW, the HRECs associated with phase I units, such as QIMR, Alfred Hospital and the success of Bellberry & QCTN – commercial HRECs – actually underpin the success of early phase research in Australia.

Recent news of international investment in the Australian clinical research sector further suggests our rumoured reputation demise is overstated. A few examples include:

• DSM Biologics who, in partnership with state and federal government, will build and operate the first major Australia-based mammalian biopharmaceutical manufacturing facility
• Cappello Capital Corp launched its Australian Desk in May, boasting the former Minister for foreign affairs, Alexander Downer, on its team
• Queensland and Eli Lilly, amongst others, have also created a $250 million venture capital fund to expand and develop the biotechnology industry in our region
• Burrill & Company and the Queensland Clinical Trial Network have entered into partnership.

Such respected organisations do not invest in our sector lightly and clearly have confidence in the value that Australia adds to international product development.

It is very important that as an industry we seek continuous improvement to our start-up timelines, lest our patient population does indeed start to miss out on new and potentially life saving experimental therapies.

However, the ‘Australian cultural cringe’ has no place in a discussion on our continued relevance as a competitive location for clinical trials. There is clear evidence that our early phase clinical research capabilities are world- class and very much an internationally competitive option being proactively sought out by international sponsors, a group some fear have lost faith in Australia.

So, let’s not throw the baby out with the bathwater but rather celebrate and brag about our growing, vibrant, early phase research and service industry, supported by a sensible and pragmatic regulatory environment, and a high quality – and, yes, timely – HREC review.

Russ Neal has worked for over 20 years in the healthcare industry, in Europe, Asia and Australia. He is COO at Clinical Network Services (CNS), a Brisbane based, contract research organisation providing clinical management support services to the BioPharma industry, particularly during early phase clinical development.