The newly released budget proposal of the National Cancer Institute (NCI) for FY04 reveals that the organization is planning to speed the approval process of new therapies to treat cancer, particularly through phase III trials, and to devote funds to a relatively new area of basic research, the microenvironment of the tumor.
If approved by the President in March and then by Congress, the budget would provide the NCI with a record $5.99 billion—a $1.35 billion increase over its FY03 budget. Last year, the NCI requested $5.69 billion, but was only awarded $4.64 billion by Congress.
Support for clinical trials would rise considerably. Funding for the National Clinical Trials Program in Treatment and Prevention would increase by $340 million, or 59%, in FY04. This is an area of high priority for NCI Director Andrew von Eschenbach, who proposes to speed the identification of the most promising new therapeutic agents and move these more rapidly into clinical trials.
The money will be used to increase the number of therapies entering NCI-sponsored clinical trials, to triple patient accrual to early clinical trials, to allow more researchers to file Investigational New Drug Applications and to speed the clinical trial grant review process. The funding would also promote collaborations between NCI-funded researchers, industry and the FDA, creating groups to identify clinically relevant surrogate endpoints, and increase funding for tissue banks.
The lion's share of the increased clinical trial funding ($223.4 million) will be dedicated to von Eschenbach's goal of doub- ling the rate at which phase III trials are completed. New trial investigators will be given a 'start-up' loan for training, research nurse support and data management, as well as for improving communication strategies to better educate patients and physicians about trials. And there are plans to expand the Cancer Trials Support Unit to consolidate administrative tasks and provide a single interface for investigators to enroll patients. von Eschenbach also wants to reimburse patients who participate in trials for costs such as travel and childcare.
One area that has undergone some of the biggest changes from 2003 is a section of the budget called "Advancing discovery and application," for which a $266 million funding increase has been requested. Funding in this area currently supports "Extraordinary Opportunities for Investment," which are considered to be the most important emerging fields of basic cancer research. For FY03, these include research on genes and the environment, molecular targets of prevention and treatment, cancer imaging and cancer communications. These four areas remain in the 2004 budget, but a new basic research area called "signatures of the cancer cell and its microenvironment" has been added; $41 million will be dedicated for research into ways in which the tumor microenvironment promotes tumor development.
Many cancer researchers now believe that effective cancer drugs will need to not only target the cancer cells themselves, but also the microenvironment, or stroma, that surrounds the tumor and supports its growth. "This is one of the most rapidly growing and exciting areas of cancer research," Suresh Molah, Chief of the Tumor Biology & Metastasis Branch at the NCI, assured Nature Medicine. "We know almost nothing about the interaction between cancer cells and their microenvironment, but we do know that you can't study tumors without studying the stroma." Priorities for funding in this area will go towards the collection and analysis of gene-expression patterns from different types of cancer and stromal cells during cancer progression.
The bulk of the budget, $2.73 billion, will continue to be used to support ongoing and new extramural research grants, which will benefit from a $524 million increase on present funds. The NCI currently supports around 4,500 external projects each year at an average cost of approximately $400,000 per grant.
