The Reporter
Issue 493, 27 October 2003
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Testing times - University's central role in cancer trials revolution

We’d all like to see new, better cancer treatments, but before these can reach patients, they first need to undergo rigorous trials to prove their effectiveness and safety. The National Cancer Research Network – co-ordinated at Leeds – has just announced that numbers entering clinical trials in England have doubled in the past two years. England now has proportionally twice as many patients entering clinical trials than the USA. This increase is just one manifestation of a quiet revolution taking place in cancer research, in which the University is playing a key part.

Nancy Lester
Nancy Lester (above)

The government-funded NCRN was set up in 2001 to benefit patients by improving the quality, integration and speed of cancer research. By doubling the numbers entering clinical trials, the NCRN – run by a Leeds-led consortium based at Cookridge Hospital – has hit its target ahead of schedule. The NCRN has brought together 34 research networks to improve the co-ordination of cancer trials. One of the major changes has been the closer link between research and treatment.

NCRN assistant director Nancy Lester said: “Research was too often seen and managed separately from patient care, but our research networks are integrated into service networks. Researchers attend clinical team meetings, so that discussions about treatment automatically include consideration of eligibility for participation in trials. This is a key factor in ensuring greater numbers enter the trials.”

In the past, trials too often took place on an ad hoc basis, dependent on different sources of funding or clinicians’ and researchers’ own areas of interest, with little national co-ordination.

“We’re working with cancer groups and funders to identify where there are gaps in knowledge, and we’ll be looking to set up trials to fill those gaps,” said Nancy Lester. “For instance, there are few trials in primary and palliative care, yet these are important areas. We’ll also help networks ensure they are working on trials which are relevant to the cancer population within their own areas.”

This process is being helped by the National Cancer Research Institute (NCRI), which brings together the main funders of cancer research and is currently chaired by director of Cancer Research UK and professor of medicine Alex Markham: “If patients are to benefit from our scientific work, it is essential that well-organised, fast and high quality clinical trials take place in this country and internationally,” he said.

This year the NCRI introduced an accreditation scheme for trials units to ensure high quality and good practice. The University’s clinical trials and research unit (CTRU), directed by Julia Brown, is among the first in the UK to gain this accolade. The unit has over twenty trials in progress, with an associated grant income of £10.5m, around two-thirds of them cancer-related. A new breast cancer trial just starting at the CTRU – one of the biggest international trials of its kind – has been adopted by the NCRN, providing credibility, recognition and support from staff within the network.

Stephanie PollardThe ‘AZURE’ trial – run jointly with the University of Sheffield – is assessing whether a drug already in use for osteoporosis could prevent the spread of secondary breast cancer to the bone, which happens in around 40% of secondary breast cancer cases. A team from the unit, led by Stephanie Pollard and Liz Graham will coordinate recruitment of over 3,000 women over three years, from 70 hospitals across the UK and from as far afield as Australia, Peru and Chile.

“Being able to recruit such a large number is key to the trial and NCRN support will help us do that,” explained Stephanie Pollard (right). “Earlier trials have shown conflicting results, but these have had much smaller patient numbers. With over 3,000 people taking part, the sheer size of the AZURE trial means it will give us a definitive answer.”

The trial will continue for over ten years, with participants regularly checked and monitored for recurrence of the cancer, but results should start coming through by 2009.

Other trials within CTRU cover rarer cancers like myeloma, which affects the blood and bone marrow. A new trial – MERIT – is looking at preventing kidney failure sometimes suffered by myeloma patients, but this poses different recruitment challenges: only five percent of the 3,000 myeloma patients diagnosed each year in the UK meet the trial’s criteria, so NCRN support is vital to maximise the chances of recruiting these scarce patients into the trial.

Kidney failure is caused by high levels of paraprotein in the blood. Some cancer centres attempt to pre-empt this problem by ‘plasma exchange’: taking out patients’ blood and cleaning out the paraprotein before replacing it. But there is no definitive evidence that this treatment works. “If the trial shows the treatment to be effective, then it can be extended to all patients at risk,” said trial co-ordinator Sue Bell. “If it’s proved not to work, then we can ensure patients are spared an unnecessary treatment.”

Ultimately, it’s the patients who stand to benefit from improvements and increases in trials and studies, and the aim of all these initiatives is better patient care, better survival rates for cancer patients and better quality of life. Something which everyone can agree on.

See also the NCRN website and a press release on the Department of Health


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