DENVER—As economic forces threaten the traditional means of support for medical research, cancer researchers will not be able to test new treatments unless oncologists begin to view themselves as clinical scientists and incorporate research into the routine care of their patients, NCI Director Richard Klausner said last week.

In remarks to the annual meeting of the American Society of Clinical Oncology, Klausner called for a massive expansion of NCI’s clinical trials system to include more oncologists and cancer patients. He also advocated the development of an electronic information network to compile and analyze the data that would be generated by the expansion.

“Progress towards reducing the burden of cancer must be a national priority, and this requires a renewed commitment to clinical research,” Klausner said. “The practice of oncology must move from the delivery of the best available care…to include progress toward the delivery of better care—not as a separate add-on of the research community, but as an integrated aspect of practice.”

In the May 19 speech, Klausner called for:

  • national policies that encourage and pay for participation in clinical research,
  • increased federal and private funding for medical research,
  • the development of a “National Cancer Informatics Infrastructure,”
  • more research into methods of clinical research.

Klausner acknowledged that it seemed a paradox to call for an expansion of clinical research at a time when academic health centers are struggling for survival: “I’m getting up here as if I’m spitting against the wind. We are all struggling to maintain the survival of our research-based academic institutions, and here I am saying that, no, we have to go beyond just saving them. We have to rethink the idea of practice as itself being part of research.”

Yet, if oncologists and patients begin to expect medical care that is based on and contributes to research, improved research funding and policies that encourage patient and physician participation in research will follow, Klausner said.

“We must create the expectation that care and research are synonymous,” Klausner said. “With that, I believe, we will gather public momentum to change the research investment and the infrastructure of how we pay for health care to make sure that research is supported.”

In the current public discussion of healthcare economics in the U.S., Klausner’s talk was not revolutionary, nor did it contain any indication of shifts in NCI policies, observers said. Since becoming NCI director two years ago, Klausner has advocated the expansion of clinical trials on several occasions.

Klausner has frequently invoked informatics—the use of computers to store and analyze information—as the tool clinical science can use to respond to the demands of healthcare payers for definitive outcomes and cost data.

Earlier this year, NCI launched two large projects, the Cancer Genome Anatomy Project and the Cancer Genetics Network, to begin the development of an informatics network.

Though its concepts were not new, Klausner’s speech was significant for its vision of a strong and healthy future for clinical cancer research, working to overcome the potentially destructive economic changes. NCI alone cannot combat these changes, but Klausner, increasingly, is using his position to advocate for federal and private healthcare policies and funding that will enhance clinical research.

The text of Klausner’s speech follows:

An interesting article I recently saw by Walter Russell Mead [President’s Fellow at the World Policy Institute of The New School for Social Research, New York City] compares the current global economic changes to the transformation of an agrarian to a manufacturing-based society seen over the previous 100 to 150 years. The current transformation from a manufacturing to a service-based economy centered around information and its technical acquisition and application is well-documented and not a new observation. Mead points out that there was manufacturing before the Industrial Revolution, but it was in the hands of tightly auto-controlled guilds—exclusive clubs of highly skilled and highly valued and well-paid artisans. It was their work that was replaced by the new manufacturing techniques. These techniques provided a flood of goods whose mass-produced, impersonal efficiency and reduced costs left laments about the loss of the unique value of products of real masters. These laments became quaint discussions of a passing time that must have seemed unimaginable to those artisans of quality.

What was striking in Mead’s article was his description of medicine as one of guilds whose time, if not passing, is certainly transforming in ways whose analogies to the guilds of yore are easy to see. I quote from him: “Computers and software will create a revolution in the production of services analogous to the revolution that powered machinery and assembly lines in the world of goods. The hospital of the future will be a fairly representative workplace. Many of the healthcare providers in the hospitals will be paid like one of today’s orderlies, rather than like a skilled and respected M.D. Orderlies with doc-in-the-box complex computers that use artificial intelligence and extensive databases will monitor patients through blood samples and sensors.”

Strengthen The Marriage Of Science, Medicine

Whether this is accurate or not, I do not know. But the fact that there are fast and massive changes in the practice of medicine is undeniable. What does Mead’s somewhat apocalyptic vision have to do with NCI and ASCO and the relationship between the two?

There is, I believe, a central task that we must embark upon together. I submit that to preserve the real values of medicine, not to protect the guilds of yesteryear, but to preserve the mission of conquering disease, the marriage between the practice of medicine and science must be dramatically strengthened.

The culture of science is a culture of innovation and of change. Science can serve and perhaps even save medicine, not just by giving it new tools, but by integrating the process of inquiry and innovation into practice.

Oncology is well poised to lead this. We are entering a period of rapid and remarkable change in oncology driven by previously unimagined advances in our understanding of cancer biology.

Our motivation is clear: we are responsible for diseases that are by and large treated far from optimally, diseases that need to be diagnosed with molecular precision, diseases that are currently detected with inadequate sensitivity, and inadequate predictive specificity.

We are only beginning to think about preventing cancer with targeted and intelligent preventive interventions. Explosive new technologies will require evaluation, validation and standardization. We are going to be increasingly confronted with an entirely new genetic paradigm of risk of cancer, a genetic paradigm of the sensitivity to carcinogens, of response to behavior, and of response to therapy. With this new paradigm will come the pressing need to answer questions we previously couldn’t even frame.

With all of these questions to answer, we need to present ourselves as engaged, along with our patients, in the process of asking and answering questions that have currently no adequate answer.

The solution in part is to have a clinical research system that extends far beyond how it is now defined, a research system that extends from healthy and well-supported academic health centers to physician research networks, to a more inclusive and extensive clinical research and clinical trials system that can involve, actively, much more of the oncology community, and that must incorporate a much higher percentage of all of our patients onto protocols, clinical research, epidemiologic and intervention trials.

Such a goal and only such a goal will allow us to test the growing number of intervention ideas in the shortest period to time possible and with the loss of the least amount of valuable and informative information.

As interventions move toward those tailored to highly specified and stratified diagnoses and targeted to the molecular machinery of the tumor, of the host response, or the host environment, there will be a need for a greatly expanded approach to clinical trials. Optimization of therapy for better short and long-term outcomes and for minimizing side effects will further fuel this need for research.

A much more informative and rich surveillance system than we currently have that looks at detection, diagnosis, treatment choices and outcomes in the context of genetic and other risk factors will require the active and informed participation of practitioners in the generation of knowledge as well as in the delivery of care.

A User-Friendly Informatics System

We need to achieve this by developing a truly useful, user-friendly and transparent informatics system. Indeed, a system that we can refer to as the National Cancer Informatics Infrastructure, a system which the NCI needs to attempt to build, developing and testing it with those who will use it. A system built to improve the acquisition of data as well as the dissemination of knowledge. We have the technology to do that. We need to do it.

The practitioners of medicine must master the rapidly evolving scientific and medical information age as assemblers, analyzers, interpreters and communicators of information, and be at the vanguard of a culture that expects the practice of oncology to be engaged in both the generation as well as the application of new knowledge.

We must work together and work with consumers and advocates and policy-makers to accept this premise and to expect it—to expect that the culture of medicine is a culture of innovation, in order to deal with policy-makers and others with the clear economic and structural demands of such an expanded view of oncology.

My own discussions with all of these stakeholders, especially recently, strongly suggest to me that the argument I’m making can be made, can be understood, and can be heard.

The concept of a National Cancer Informatics Infrastructure to enable a dramatically enhanced research participation of physicians, patients and the population-at-large resonates with a growing and increasingly vocal demand that progress towards reducing the burden of cancer must both accelerate and be a national priority, and that this requires a renewed commitment to clinical research.

It is on the radar screen in Washington, believe me. We see it in multiple manifestations, such as the recent suggestion, gathering steam, that the research budget of NIH be doubled within five years.

Integrate Research Into Practice

The goal of the practice of oncology must move from the delivery of the best available care. It must move beyond that to include progress toward the delivery of better care—not as a separate add-on of the research community, but as an integrated aspect of practice.

To do this will require efforts in four areas:

First, we need policies that both allow and encourage participation of patients, populations, and physicians in research. We need all providers to make sure that they allow and encourage that, and indeed, expect it, for that should be the standard of care. And payers must pay for it. As you know, we have been engaged in discussions with both federal and private payers, and they are willing to discuss the parameters by which clinical costs associated with clinical research are paid for.

Secondly, we need to deal with investment, especially federal, but also on the part of the whole health system, into R&D, for dollars will clearly be required.

Now, I’m getting up here as if I’m spitting against the wind. It’s a paradox. We are all struggling to maintain the survival of our research-based academic institutions, and here I am saying that, no, we have to go beyond just saving them.

We have to rethink the idea of practice as itself being part of research. We need to stop thinking about research as something someone else will pay for, that is an add-on, that is research and training, and recognize that when we have medical care that does not adequately prevent, diagnose, detect or treat a disease, then that medical care must be in a culture of innovation; therefore, a culture of research. We must create the expectation that care and research are synonymous. With that, I believe, we will gather public momentum to change the research investment and the infrastructure of how we pay for health care to make sure that research is supported.

The third thing we need is infrastructure. We can’t do what I’m saying unless we create an infrastructure that allows it, an infrastructure that only now is conceivable due to the new economically and accessible electronic communications technologies.

A recent report from the National Academy of Sciences, called “Bits of Power,” addresses this issue for the dissemination of information and the acquisition of information internationally, including into developing countries. If we can conceive of this for the entire world and for developing countries, we can certainly conceive of such an infrastructure for the United States.

The infrastructure must enable the research, must reduce the disincentives to participate, and include incentives to sign on to it.

The fourth thing is that we need research into research. We need research into new and more effective ways to ask questions and to collect and analyze data, that will allow a great expansion in clinical research, that will allow us to fill what will be an enormously growing gap between ideas and the ability to test those ideas. How to better study and monitor behavior and psychosocial issues, epidemiology, intervention, and survivorship. We will need research into how it is that we best close the gap, while we watch now a potentially expanding gap between basic discoveries about cancer and their application.

We must all participate in making oncology more scientific. Not just in the application of science, but in the generation of knowledge.

Creators Of New Information

This is an enormous challenge. But I think with it, we can capture the public discussion about what we want this society to do in terms of reducing the burden of disease. It is an enormous challenge that will involve both expansion and new approaches to data acquisition and hypothesis testing.

In the information age, we must all be more than craftsmen of information, and become what will always be irreplaceable: creators of new information.