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The drug industry will carry out fewer trials in the United Kingdom unless electronic patient records can be deployed quickly throughout the NHS, warned Richard Barker, director general of the Association of the British Pharmaceutical Industry. Dr Barker was speaking last week at a meeting organised by the UK Clinical Research Consortium on the use of electronic patient records for research and to improve health.
Dr Barker said that other countries are now able to host good quality trials at a much lower cost than is possible in the UK, and he believes that an NHS-wide electronic patient record system could be hugely attractive to the drug industry, as it would allow drug companies to easily identify patients fitting a trial's inclusion and exclusion criteria.
An electronic registry would also allow drug companies or regulatory agencies to carry out detailed post-approval surveillance of a product's safety and efficacy. “People do a lot of meta-analysis now—this is pseudoscience most of the time, unfortunately,” said Dr Barker. “Wouldn't it be wonderful to be able to look at everyone who takes a new medicine and say, ‘Where are these rare side effects? Do they exist and how serious are they?'”
Dr Barker believes that the UK is being “ponderous” in taking up this opportunity. “We have only a very few years to get this right. I personally would say that if we have not built a distinctive capability in this that people begin to recognise in three years, and [if we have not delivered] very substantial capability within five years, we can forget this . . . Someone else will be doing the research, not the UK,” he said.
Carol Dezateux has been leading the consortium's efforts to simulate the advantages and pitfalls in rolling out a nationwide patient registry. “We are not starting from ground zero in this country. We are already using record linkage in a range of very creative ways to address important problems,” she said. As an example of the benefits of electronic registries she cited a recent study that used record linkage to show a protective effect of a low dosage of aspirin against colorectal cancer (Lancet 2007;369:1603-13).
Dr Dezateux explained that very long term studies are essential to identify this kind of effect. “The significant finding was only found after 10 years' follow-up,” she said. “We cannot afford, ethically, to ignore the opportunities for record linkage in addressing these really major problems.” She added, however, that concerns about patients' confidentiality must be taken seriously.
The conference also heard speakers from the United States and Denmark. Lawrence Deyton, chief public health and environmental hazards officer at the US Department of Veterans Affairs, described how his organisation's electronic patient record system helps deliver the best possible care to patients. The system reminds him when to order laboratory tests and is easily able to pull up clinical data on each of his patients.
“There is little doubt that there are huge opportunities to improve patient health if we use electronic patient records properly,” said Mark Walport, director of the Wellcome Trust, which hosted the conference. “We are well positioned if we can get the conditions right.”