Setting Priorities: Transforming Scientific Research Into Better Health Care

The past few years have seen unprecedented advances in medical research, creating new opportunities but also raising myriad questions for the academic medicine community. Some questions being asked include which areas of research have been unduly overlooked, and which ones deserve to be prioritized in years to come.

Daniel Blumenthal, M.D., Ph.D., professor and chair of the Department of Community Health and Preventive Medicine and associate dean for community programs at Morehouse School of Medicine, thinks that more community-based research programs should be a top priority for the 2003 agenda.

We desperately need better approaches for improving prevention in the community," Dr. Blumenthal says. "That's where we'll get the most gain for our research dollar, and that's where we'll have the most opportunity to improve the health of the public."

Focusing on this type of research and creating more programs of community-based prevention can help to address effectively the country's healthcare disparities, he says. "What we see as health disparities represent a large part of the prevention gap. For example, African-Americans are less likely to be screened for cancer, less likely to have risk factors such as hypertension under control, and more likely to die from preventable diseases such as lung cancer. The most promising way to address these types of disparities is by improving our community-based approaches to prevention," Dr. Blumenthal says.

Most of the progress that has been made in addressing major public health problems is due to an increasing focus on prevention techniques and on research analyzing the effects of prevention, he adds. "Our ability to treat cancer has improved very little in the last decade and yet cancer mortality and incidence rates have been coming down since the 1990s," Dr. Blumenthal notes. Some of the reasons for the drop, he says, are the public's greater awareness of the role lifestyle choices can have on preventing certain types of cancer, and the healthcare community's greater success in detecting cancer in its early stages.

"Mortality rates for breast cancer have been coming steadily down even though approaches for treatment of breast cancer have changed very little," he says. That's partly because mammography rates have increased dramatically over the last decade, Dr. Blumenthal explains. "By improving early detection rates of breast cancer, we have been able to save lives not because we have better methods of treating breast cancer, but because we have better approaches for detecting breast cancer early."

The increase in mammography rates is due to a large amount of re- search analyzing this exam and its implications, Dr. Blumenthal explains. "There has been a lot of research into how to better offer mammograms to women, how to overcome barriers to mammography, and how to get the word out about this exam and how important it is," he says. "Now we need to do the same thing for colorectal cancer screening." There's a significant disparity between minorities and whites in colorectal cancer incidences and mortality, as well as in screening rates for that condition, he explains.

"We need more support for finding better ways to reach people with known prevention modalities so that we can reap the benefits of what we know and prevent avoidable deaths," Dr. Blumenthal concludes.

Analyzing new technologies

Another type of research that needs to be emphasized is the study of new technologies and therapies, according to Sean Tunis, MD, MSc., Acting chief clinical officer at the Centers for Medicare and Medicaid Services (CMS). "This type of research is usually done as an afterthought, a relative low priority compared to all of the research that goes into developing the next generation of new technology," says Dr. Tunis. "We have focused a lot of clinical research funding on developing novel treatments and new discoveries, and rarely devote enough attention and resources to evaluate how to properly use technologies emerging from the basic studies that were funded years ago."

Last year, the Institute of Medicine's Clinical Research Roundtable (CRR), a group that provides a forum for the discussion of challenges facing clinical research, sent a survey to 646 private health plans inquiring about their clinical research priorities. The purpose of the survey was to assess the technologies and services that health insurance administrators have to make policy decisions about without proper clinical studies as evidence to back up their choices. Examples of the kinds of procedures and technologies that survey responders indicated needed to be tested in clinical trials included some of the minimally invasive procedures for back pain and prostate surgery, microwave therapy, and laser techniques, according to Dr. Tunis.

"There are plenty of new technologies that are proliferating and never get formally evaluated compared to other technologies or to the standard clinical approach [used to treat certain conditions]," he says.

Besides the clear benefit to health insurance officers and others having to make health policy decisions, greater knowledge of how new therapies and technologies compare to older alternatives benefits patients, Dr. Tunis argues.

"As we increasingly focus on having informed patients consult with doctors to make decisions about what medical interventions to choose, the doctors and patients need reliable information on the comparative risks and benefits of the various alternatives," he says.

"Those are exactly the kinds of studies that tend not to be done nowadays, the head-to-head comparative analyses of existing alternatives for diagnosing or treating a problem. By having more of this type of research, people will be able to make informed decisions that are right for them, and will also be able to make choices that are more likely to produce the clinical benefit that they expect," he says.

Academic medical centers (AMCs) can help address this research deficiency by demanding higher quality evidence as part of their decision-making processes, says Dr. Tunis. "Many medical schools are already doing this now by focusing on training and critical appraisal, and evidence-based decision making," he says. "That by itself creates a market for the kinds of clinical research that I've described."

Another approach AMCs could take involves making clinical research tools and strategies instruction a standard part of medical education. "If we are going to substantially expand trials of existing technologies and compare them to either newer or older therapies, that will require that clinicians think about referring an increasing fraction of their patients into these sorts of clinical studies, as opposed to trying to make the best guess for what treatment these people should get based on the poor quality of current research," he says.

Moving toward better care

Myron Genel, MD, of Yale University, argues that a major research priority should be reengineering the clinical research enterprise to translate the advances in the basic science lab and clinical research into practice settings.

Perhaps one of the larger questions surrounding clinical research is whether or not recent advances in this arena, such as breakthroughs in basic biomedical sciences, stem cell biology, biomedical engineering, and other scientific disciplines, are being successfully translated into better health care. Myron Genel, MD, professor of pediatrics and associate dean at Yale School of Medicine, argues that this is not the case.

In his opinion, a major research priority should be to reengineer the clinical research enterprise to translate the advances in the basic science lab and clinical research into practice settings. Drawing from a March 2003 Journal of the American Medical Association (JAMA) article, which he co-wrote, Dr. Genel describes the "two translational blocks" that impede the translation of lab advances into practice settings.

"One translational block is the 'proof of concept' block, the one translational block that everyone talks about," he says. "The most urgent example of this concept is the translation of all the knowledge from the genome into a practical application."

The basis for the "translational blocks" argument in the JAMA article came from a CRR analysis. "The Clinical Research Roundtable concluded from workshops [held with key stakeholders] that the more significant block exists at the level of translating the knowledge that we do have into clinical practice and into actual healthcare settings," says Dr. Genel.

In explaining why these blocks exist, Dr. Genel credits the poor coordination between parts of the clinical research system. "Different agencies have different levels of responsibility for different portions of the system," says Dr. Genel. "Whereas the NIH [National Institutes of Health] clearly is vested in the application of basic research—and they do quite a bit of quantitative and qualitative research—it is not their major mission."

Funding concerns

"The Agency for Healthcare Research and Quality [AHRQ] clearly has responsibility in this area, but it is not very well funded," Dr. Genel says. "The NIH will receive close to $28 billion in this year's budget, and the doubling of its budget will be completed. The AHRQ, in comparison, receives around $300 million and has responsibility for an area that is even more troublesome in terms of the application of knowledge into health care. There are a lot of other groups that are vested and have an interest in these areas but they are not very well coordinated."

Another problem that can contribute to these translational blocks and that pertains specifically to academic health centers relates to staffing issues. "The individuals who are most capable of participating and being engaged in clinical research also have a variety of other responsibilities" in AMCs, says Dr. Genel. Because of current economic pressures and workforce shortages, these individuals are indispensable healthcare providers, often leaving them little time to engage in clinical research.

"The real priority is to streamline the system so that there's a much more efficient transfer of knowledge into meaningful healthcare," Dr. Genel concludes. "That's a challenge for all aspects of the system - it's not something that's going to be solved by the NIH, or AMCs, or by managed care organizations; it's only going to be resolved by all of these stakeholders working together in a collaborative way."

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