Co-operative cancer groups across the US may have to shut down or delay as many as 95 clinical trials this year because of successive cuts in federal funding for the National Cancer Institute.

The NCI has asked the groups to lower their costs by 10% for the 2007 fiscal year (FY 2007). This means the 10 groups (nine adult and one paediatric) sponsored by the Institute in the US may have to deny some 3,000 patients the chance to participate in clinical trials – a substantial portion of the 25,000 or so patients enrolled in co-operative oncology trials each year.

The Coalition of Cancer Cooperative Groups, the leading national non-profit organisation devoted solely to oncology trials, says its budget has been shrinking since 2003 but this is by far the most dramatic reduction to date. At least two of the co-operative cancer groups that started their budget cycles in December or January are already laying people off and cancelling trials, it adds.

Impact to hit all major cancer trials

The full impact of the cuts will hit trials for all the major types of cancer, although niche indications such as melanomas, sarcomas or head and neck cancers are expected to suffer in particular. The co-operative groups tend to pick up areas of research that may be of limited interest to the pharmaceutical industry, such as head-to-head trials of cancer therapies or sub-groups with relatively small populations.

Budgetary attrition is also expected to make a large dent in expensive tissue banking activities. With the shift towards personalised medicine, clinical trials increasingly demand tissue and blood sampling studies, the Coalition notes.

Moreover, with funds spread more thinly, cancer trials will have to rely increasingly on supplementary funding from the hospitals that run them. The NCI reimburses physicians for the research costs of a trial at a flat rate of US$2,000 per patient case, whereas the average per-patient cost for a government-sponsored study is about US$4,500, the Coalition points out.

Budget cut for first time in 10 years

On a recent visit to the US National Institutes of Health (NHI), President George W. Bush said federal funding for cancer research had grown by 25-26% since 2001. In FY2006, however, the NCI’s budget was cut for the first time in a decade, by US$32 million from a total budget of nearly US$4.8 billion.

The omnibus appropriations bill approved by the US House of Representatives last month would increase total NIH funding by US$619 million for FY 2007 but would slash the NCI budget by as much as US$40 million. Another US$9 million cut to NCI funds is mooted in the federal budget proposal for FY 2008 released by President Bush last week.

What especially worries cancer researchers about the waning federal support is that the latest data suggest the tide is starting to turn in cancer management. In 2004 the number of cancer deaths in the US fell for the second year running, dropping by 0.5% to 553,888, according to the American Cancer Society.

In this light, the NCI cuts and their impact on co-operative cancer trials “couldn’t be coming at a worse time”, said Dr Robert Comis, president of the Coalition of Cancer Cooperative Groups. Just as patient hopes were being raised by a widening flow of new drugs and a shift toward targeted therapies, federal policy was leaning in a direction that could put the system of government-funded clinical trials in the US “in serious jeopardy”, he warned.

The NCI’s Clinical Trials Cooperative Group Program was set up in 1955 and involves more than 1,700 institutions spanning the US as well as Canada and Europe.