Editorial: Is the UK NHS a good place to do clinical trials?
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RY STEWART PUBLICATIONS 1478-565X. J O U R N A L O F C O M M E R C I A L B I O T E C H N O L O G Y . VOL 11. NO 3. 205–207. APRIL 2005
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Editorial
In addition, although the network concept is a good and valid one, it addresses only a part of the problem. Many other aspects remain untackled. For example, whenever a new industry-sponsored clinical trial is placed in an NHS Trust, a bureaucratic process ensues that involves the definition of a budget and contractual obligations by the Trust R&D office, Local Research Ethics Committee (LREC) approval and indemnification of the Trust by the Sponsor. Here, the unfortunate impression is that the processing and management of these tasks is no one’s first priority in a majority of Trusts. Because of this, clinical trial set-up in the NHS is uniformly slow and frustrating for Sponsors. Until resources are ploughed into this area and somebody’s bonus or promotion depends on the efficient management of clinical trial bureaucracy, it is hard to see how this will change. Once a trial is running, competition for beds is still an issue if in-patient stays are part of the protocol. The lack of beds dedicated to clinical trials could be overcome if the resources were available. Recruitment often lags behind what was promised and envisaged. While this is often blamed on too many trials chasing too few patients, an alternative explanation is a failure of trials to be adequately publicised and for referrals to be negligible even when a trial is well known. A cultural change might be deemed necessary. Sophisticated diagnostic modalities such as computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning that might be taken for granted elsewhere are often lacking, rationed or booked far in advance, thus causing delays. Again, resources are at the heart of the issue. Finally, the imposition of GMP requirements at the moment is causing major headaches. Delays by an overstretched MHRA in accrediting manufacturing units are causing problems in clinical trial initiation. While, it is hoped, this is just a teething problem, it has to be remembered that every pharmacy in the land that prepares an intravenous infusion for a clinical trial now requires QP release. All need accreditation. If we are to have more regulation, it has to be administered efficiently. For products involving genetically modified viruses, the situation is even more dire, with health and safety issues to be resolved on a Trust by Trust basis, often at great expense of time and energy. Suffice it to say that only a few hospitals in the UK are set up to deal with even the most straightforward of these products, which bodes ill for the conduct of Phase III trials with these agents in this country. A recently published article by Bamford et al.1 graphically illustrates the lengths to which one Teaching Hospital Trust has had to go to enable a gene therapy clinical trial programme to go ahead. It is hard to imagine that, if this is the norm, major clinical trials of these advanc
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