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The Lancet Oncology

Saturday, December 6, 2008

What is the practical impact of quality cancer research?

How does biomedical and clinical research impact daily practice in cancer care? This question has been asked with increasing frequency over the last decade. Results of a study published earlier this year in the British Journal of Cancer, give the answer. The results shows how research in the United Kingdom is helping to deliver significant clinical improvements for cancer patients in the United Kingdom and around the world.

To date, there are 43 oncology guidelines and associated Health Technology Assessments (HTA) published (up to October 2006) in the United Kingdom. Each guideline and associate HTA has a clear evidence base in the form of references, many of which are papers in peer-reviewed journals. Researchers analyzed these guidelines for cancer care from the National Institute of Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC), and found that papers from UK-based cancer researchers are cited nearly three times more often than would be expected.

These guidelines form the basis of the clinical care given to cancer patients and are devised from an evidence base which includes peer-reviewed research.

In contrast to held idea that the pharmaceutical industry is the biggest sponsor of biomedical research, the study reveals that Cancer Research UK supported over one-third of the clinical trials which were cited as evidence in these guidelines. The number of studies is more than the pharmaceutical industry as a whole, or the UK government. This outcome seems to confirm that altough the private sector will have an important role in identifying and implementing research priorities in cancer research and offer substantial and welcome funding, it does not set the overall research priority end execution. The main reason is that industry by its very nature is partisan and concerned only with commercially viable areas. On the other hand, government agencies, charitable organizations and universities have wider concerns for all cancer research.

Lead author Professor Richard Sullivan, who conducted this study when he was director of clinical programs at Cancer Research UK, and is now at the London School of Economics and the European Cancer Research Managers Foundation, said: "Our study demonstrates the real practical impact of research funding in the UK and shows that cancer research in the UK is punching above its weight.”

International impact
Previous studies have shown a strong sociological tendency for clinical guidelines to focus on domestic research rather than the best international research. The impact of UK research in this study was compared with a standard set by previous studies measuring how far individual countries are expected to deviate from the international standard.

Professor Sullivan continued: "Even taking into account the fact that UK clinical guidelines are inevitably going to be skewed in favor of UK-based research because of the make-up of our healthcare services, we still found that the impact of UK cancer research on clinical practice was disproportionately higher than would be expected - which is a credit to the exceptionally strong research base that we have in this country. We also found indirect evidence that UK cancer research has as impact internationally - particularly in Western Europe."

In numbers
Cancer research conducted in the UK contributes to approximately 6.5 per cent of the world's oncology research output, but almost 20 per cent of cancer research emanating from the UK contributed to the 43 NICE clinical guidelines which were devised before 2006.

The research team analyzed just over 3000 references which were cited across almost 800 research papers over a period of 25 years. The peak years of guideline references were between 1999 and 2001. They looked at the geographical breakdown of the research as well as the type of research conducted and the impact factors of the journals it appeared in. The researchers noted that studies from universities, hospitals and institutes based in Oxford, Cambridge, Edinburgh and Glasgow were the most frequently cited.

Professor Sullivan noted: "This is an interesting finding...[and] this may be because SMC guidelines tend to pay close attention to research coming out of Scotland - but it was still a significant contribution from the two cities."

Kate Law, director of clinical trials at Cancer Research UK, said: "This research highlights the importance of clinical trials carried out in this country and it's great to see that studies funded by Cancer Research UK played a major contribution towards these guidelines. This demonstrates that our research has a significant impact on the clinical management of cancer patients. NICE is seen to be a world leader in the development of quality, evidence based guidelines for cancer care, so it's crucial that the Government and NHS work together to ensure that these guidelines are being uniformly implemented across the country so that all cancer patients can benefit from them."

Although the impact of studies conducted in the United Kingdom is considerable, British researchers in general are concerned about the increased bureaucracy. One researcher noted that patients with cancer are dying because bureaucracy is stifling research. In general, it takes now takes five times longer than in the early 1990s to get a breast or bowel cancer drug into trials.

Professor Sullivan agreed that: "We absolutely agree that research should be carried out in a proper regulatory framework, but because of complex, contradictory, and opaque regulations patients aren’t being protected, they are being failed." The result is a 'culture of fear' in which many now playing it ultra-safe and avoiding sensitive but potentially important areas of research.

Researchers find it incredibly frustrating the added burden of bureaucratic rules slow down the development of new drugs. They agree that this kind of delay is undoubtedly costing lives. They also feel that the added (European) regulations do not provide greater patient safety.

Even though the increase in guidelines may be a concern, most researchers feel that the NICE recommendations are truly based on systematic reviews of the best available evidence. And even when minimal evidence is available, recommendations are based on the opinion of what constitutes good practice.

Also read:
Lewison G, Sullivan, R. The impact of cancer research: how publications influence UK cancer clinical guidelines, British Journal of Cancer (2008) 98, 1944–1950. Click here for the PubMed abstract.

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