A report presented to the UK government and published on November 17 proposes to streamline clinical trials offered through the country's health system, the National Health Service (NHS; London), to provide local biotech companies with a competitive advantage and put the country on the map of clinical trials providers. But industry insiders fear that chronic underfunding of the NHS and new European regulatory requirements for authorization of trials could reduce the impact of such plans.
The UK government is expected to respond by June 2004 to a proposal that is designed to make the country the choice for clinical trials.
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A key recommendation of the Bioscience Innovation and Growth Team (BIGT) report, 'Bioscience 2015: Improving National Health, Increasing National Wealth,' involves the creation of a National Clinical Trials Agency (NCTA) to be sponsored by the Department of Health. The NCTA would become the central point of coordination for company access to the NHS clinical trials centers across the United Kingdom and will be in charge of increasing their cost effectiveness. An estimated £425 ($730) million would be needed over five years to fund the ambitious plan. Enrico Colli, chief medical officer of urology and inflammatory disease company BioXell (Milan, Italy) finds the idea of a central point of contact attractive—it could be a way for the UK to leverage its "crucial" long-term experience in running such trials.
The UK has a historical lead in the clinical trial field because sponsors need to obtain approval from a single ethics committee, unlike other European countries that require lengthy approval processes. Unlike in other countries, the availability of funding from medical charities, such as the Wellcome Trust (London) and the government-funded Medical Research Council (London), also contributed to the country's experience in clinical research.
But the NHS does not have the financial backing to provide a clinical research infrastructure and the workforce capabilities to effectively perform clinical trials competitively with other countries, according to a report called 'Strengthening Medical Research,' published in October 2003 by the Academy of Medical Sciences (London, UK). "It is a significant challenge [for the NHS]," says David Oxlade, CEO of Xenova (Slough, UK), adding "It will take time, money and change of culture and attitude, but it is not a challenge which is out of reach."
The BIGT proposal should increase the competitiveness of UK biotech firms by providing easy access to a readily available infrastructure of clinical trials. "It should be an advantage," says Oxlade. More specifically, the BIGT report suggests that by engaging in public-private partnerships, companies will benefit from a lower development cost. David Cooksey, chair of BIGT and of venture capital firm Advent Venture Partner (London), believes that more drugs could thus be brought to market sooner.
Improving clinical trials in the UK would not only benefit the local bioindustry, but could become a key business in itself. The authors of the BIGT report write that by upgrading the UK's clinical trial capability, the country should become the place of choice to conduct clinical trials, competing with Eastern European and Asian clinical trials service providers (see Box 1). The UK's tradition of clinical excellence can provide added value—for example, through the way the protocol is designed or by providing access to the latest technologies such as genomics and imaging—to companies, which look at more than price when choosing a territory to perform their trials. And Cooksey expects company-funded trials in the UK to help "increase the revenue of the NHS" and therefore support an increase in NHS-based research.
Companies typically carry out their clinical trials where they can complete them in the shortest amount of time. Each day saved may cut costs tremendously and help bring a drug to market faster. But industry insiders worry that the new European clinical trials directive (2001/20) soon to be transposed into UK law would add unnecessary red tape and thus hamper British competitiveness on the global trials scene (Nat. Biotechnol.21, 838, 2003). With the new directive, the agreement of ethics committees will no longer be enough to gain authorization of trials. Instead, the green light will come from regulatory agencies in Europe and that could take up to 60 days to grant authorization to phase 1 trials. UK lobbying groups have campaigned to reduce the maximum authorization delay to 14 days. By contrast, Canada amended its legislation in September 2001, effectively cutting down authorization for phase 1 trials in healthy volunteers to a 7-day review target, instead of the 30 days imposed by law.
Finally, the BIGT report recognizes the difficulties that biotech companies encounter owing to their lack of experience in performing trials. The proposed NCTA would also act as a consulting body and provide guidelines on how to perform adequately sized trials and advice on protocol design. Biotech firms' lack of experience in carrying out trials is common everywhere: for example, US FDA Commissioner Mark McClellan has spoken publicly about a plan to set up a system for FDA staff to share information on protocols for clinical trials they previously examined. Such increased communication should help biotechnology companies run their trials more effectively and ultimately decrease costs.
