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International Clinical Trials

Editor’s Comment

As I write, there is yet more financial gloom arising from Greece’s inability to meet its commitments with respect to its debt repayment. It is conventional to blame ‘The Bankers’ for the initiation of the world financial problems that apparently started with the crash of Lehman Brothers in September 2008. But the current problems, especially in countries such as Greece, Italy and Ireland, have also stemmed from burgeoning government expenditure on social security and healthcare. This latter expense is, of course, exacerbated by the welcome fact that we are living longer and are on the whole healthy for longer.

Over the last half century, life expectancy in the industrialised world has risen dramatically – and so has the healthcare bill. It is fair to ask if population ageing is the main reason. It is inescapable that while ageing does affect health spending, it may be far less important than many think so that obsession with an ageing population may be a dangerous red herring that can prevent dealing with the real culprits of rising cost. The fixation of many policymakers on ageing seems to suggest that higher healthcare expenditure is inevitable, and therefore is diverting attention from the real causes of growth of the healthcare sector. These include failures in insurance markets, distorted incentives in reimbursing both patients and doctors, and importantly for us in the pharmaceutical industry, technological progress in medicine combined with an overall rise in income. Blaming population ageing distracts from the decisions that really ought to be made, such as devising appropriate incentives for curbing excessive provision of publicly financed healthcare and evaluating the social value of new medical technologies.

No-one denies that the price of modern therapies can be so substantial that some countries have added the extra value-for-money regulatory hurdle that is exemplified by the English NICE. A major part of the cost of new medicines arises from the apparently inexorable rise in the cost of drug development. In Europe, part of the rise in expenditure may have come from what are claimed to be unnecessary complexity and bureaucracy that are hampering the progress of medical research by pushing up the time and costs needed to get clinical studies underway. An influential group of academics and industry experts blames the European Union’s Clinical Trials Directive (CTD), which they claim needs substantial modification not least in the area of harmonisation. Professor Liselotte Højgaard, Chair of the European Science Foundation’s European Medical Research Councils believes it’s “vital that revision recommendations are put forward to ensure that Europe continues to be seen as an attractive destination for clinical research,” while Sir Mark Walport, Director of the Wellcome Trust notes that “increasing participation in clinical trials is crucial to fully realising the benefits of medical research for health and the economy in the UK.”

In response to the lack of harmonisation, a voluntary harmonisation scheme has arisen as noted by Peggy Cance and Karen Goode from EUDRAC (page 96). They point out that a revised CTD due in 2012 will be welcomed throughout Europe, as it is expected that the conduct of clinical trials will become more uniform as a result. This should enable new medicines to be brought to patients more quickly and more cheaply.

Even so, it is not surprising that companies are increasingly turning to lower cost economies for pivotal trials such as the Ukraine (as discussed by Oksana Maksimova from Clinical Trials Logistics, see page 66) and other CEE countries. See the article Christian Reh at PRA (page 10) who comments that “CEE countries are proving to be a very interesting market even in early phase trials, especially when it comes to patients being the study population. With increasing experience of competent authorities and ethics committees, this geographic area will play a significant role in successful drug development strategies.”

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