Another story is unfolding in a small suburb outside Buffalo, N.Y. A cancer patient named William B. visits his oncologist to treat the stage 4 glioma that has invaded the left side of his brain. William asks his Buffalo-based doctor if he is aware of any experimental drugs or research programs that might help him. The physician, already two hours behind schedule with 20 more patients to see before running back to the hospital, stares back at William blankly, says he will look into it, and scribbles a reminder in the paper chart. Of course he never follows up. So William never learns about the clinical trials at an academic medical center in Cleveland, where a doctor — we’ll call her Dr. Kelly — is struggling to recruit a sufficient number of glioma patients to test the efficacy of a new investigational drug.
These two stories represent the rule, rather than the exception, in biomedical research. In the first case, expensive redundancy drives up the cost of taxpayer-funded basic research while information silos undermine the potential for scientific collaboration. In the second case, a patient is denied treatment that might have been beneficial while inefficiencies in recruiting research subjects drive up the cost of a clinical trial designed to test a promising new compound.
The second story also illustrates a particularly compelling challenge: how to build stronger links between medical research and medical practice. Doctors and their patients desperately need information on the latest therapeutic breakthroughs and clinical trials, but “bench scientists” and research physicians who run clinical trials rarely interact with community physicians. And yet the care that a patient receives represents the end of a long value chain to which each of these individuals, and many others, make important contributions.
Finally, both stories help explain the current stagnation in new drug research. The pharmaceutical industry and the National Institutes of Health (NIH) have each more than doubled their investments in research and development over the last decade. Yet despite this dramatic increase in spending, the number of new chemical compounds submitted to the U.S. Food and Drug Administration (FDA) annually has declined from approximately 45 in 1996 to approximately 25 in 2003, according to a March 2004 FDA report titled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The shortfall in biomedical research won’t be cured by infusions of cash; we’ve tried that. What is required is a fundamental change in the way research is conducted.
Collaboration and Communities
The National Cancer Institute (NCI), the lead federal agency for cancer research, is confronting these challenges through a paradigm-changing program called the Cancer Biomedical Informatics Grid, or caBIG. Launched by the NCI’s Center for Bioinformatics in 2003, caBIG aspires to create an informatics network that connects cancer researchers (and eventually all researchers) nationwide — a World Wide Web of cancer research.