American Association for Cancer Research

Cancer Research Policy

A strong commitment to research can deliver new scientific breakthroughs that will help detect disease earlier, emphasize prevention over treatment and improve the public's health overall. By strengthening that commitment to research today, we can accelerate progress to help address our nation's growing health care needs and reaffirm our role as world leaders in science. On this page you will find information about some of the key policy issues that pertain to the rate of progress in basic and clinical cancer research.

 

 

  BIOMARKERS

 

Biomarkers, also referred to as molecular markers or signature molecules, are indicators of normal or abnormal processes in the body. They can be used in the detection, diagnosis and management of many types of cancer and play a key role in the development of cancer therapies.

In 2000, the National Cancer Institute launched the Early Detection Research Network (EDRN), a collaboration of dozens of institutions working together to identify and develop biomarkers for clinical use to estimate cancer risk and evaluate new ways of finding cancer in its earliest stages. Only a few biomarkers are routinely used in oncology today. Although advances in technology have made it easier to examine many potential biomarkers in a single experiment, discovery efforts are still hampered by the limitations of current technology. In addition, most candidate biomarkers never advance beyond the discovery phase and the number of biomarkers validated for use in drug development or qualified for clinical applications is still very small.

A more coordinated, comprehensive approach to biomarker research and development will improve cancer prevention methods and early detection technologies, and will provide new strategies for tailoring therapies to fit the needs of each cancer patient's unique biology.

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  BIOSPECIMENS

 

Human biospecimens, such as tumor samples, are fundamental to basic and clinical research. Cutting-edge and potentially lifesaving cancer research is stalled, however, by the absence of a robust network of biospecimen and tissue collection banks. Moreover, the lack of consistent standards for collection, identification, retention and storage of biospecimens compromises tissue quality. Removing barriers and offering new incentives will allow researchers to tap into the latest breakthroughs and communicate ideas, successes and limitations in various approaches to conquering cancer.

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  COMPARATIVE EFFECTIVENESS RESEARCH

 

Comparative effectiveness research (CER) is the investigation into what medical tests, treatments or procedures work best for which patients under which circumstances. At its best, proponents believe that CER could lead to a more efficient, less expensive health care system by increasing the amount of information available to patients and their physicians when making personal treatment decisions and thereby reducing ineffective or unproven care. There is fear, however, that the results of comparative effectiveness studies could ultimately be used to justify a form of health care rationing where patients are denied potentially lifesaving treatments simply on the basis of cost. There are also concerns that if CER study designs fail to take into account patient individuality, the resulting data would be insufficient for making real-world medical decisions but might nevertheless be used by insurance providers to make one-size-fits-all coverage decisions. Minority and disability groups, for example, have expressed concerns that most CER to date has not taken into account broad enough population samples.

The recently enacted health care reform package, the Patient Protection and Affordable Care Act (H.R. 3590) directs the establishment of an independent nonprofit center to conduct and oversee this emerging area of research, which it refers to as "patient-centered outcomes research." The law includes a clause forbidding the research findings from being construed as guidance for payment, coverage or treatment. The federal government is also forbidden from using the data solely to deny coverage.

 

REPORTS:

Dr. Harold Sox, co-chair of the Institute of Medicine (IOM) panel on comparative effectiveness research (CER), summarizes how federal agencies are spending the $1.1 billion allocated to CER through the American Recovery and Reinvestment Act, how CER priorities recommended by the IOM panel have fared in the agencies' funding programs and developing plans for a national CER program.


Endorsed by the AACR and 24 other leading health advocacy groups, this new report uses cancer as a case study for exploring ways to improve medical decisions through comparative effectiveness research (CER). The report is authored by a group of leading academic scientists, clinicians and advocates in the field of cancer who make innovative recommendations for improving the way that CER is conducted in the U.S.


As mandated by the American Recovery and Reinvestment Act of 2009, this report was released by the Federal Coordinating Council for Comparative Effectiveness Research to provide for the coordination and oversight of the federal comparative effectiveness research.


As mandated by the American Recovery and Reinvestment Act of 2009, this report was released by the Institute of Medicine (IOM) to guide funding priorities for federal comparative effectiveness research.


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  CLINICAL TRIALS

 

The development of novel new ways to diagnose, prevent and treat cancer depends heavily upon an effective clinical trial system. Unfortunately, fewer than five percent of adults diagnosed with cancer each year will participate in a clinical trial despite the fact that, for many patients, clinical trials present an opportunity to receive the newest, most innovative treatments for their disease. Barriers to greater patient participation include burdensome regulatory requirements and a lack of awareness. The high cost, complexities and regulatory requirements associated with opening and conducting a trial also make it increasingly challenging for trials to be rapidly executed.

The recently enacted health care reform overhaul, the Patient Protection and Affordable Care Act (H.R. 3590) addressed a major barrier to clinical trial participation by requiring that health plans cover routine costs for patients on clinical trials. The language covers all clinical trial stages for cancer and other life-threatening diseases.

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Collective recommendations from the Institute of Medicine to reinvigorate the NCI Clinical Trials Cooperative Group Program and strengthen its position as a critical component of the translational pathway from scientific discov­ery to improved treatment outcomes for patients with cancer.

 

Strategies from the NCI Clinical Trials and Translational Research Advisory Committee to reduce clinical trial activation time within the Clinical Trials Cooperative Group Program. This is part of a broader effort to decrease the time to complete clinical trials.

 

A policy-focused guidance document intended to improve policymakers' and other stakeholders' understanding of the process, economics and barriers related to cancer clinical trials.

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  GENERIC BIOLOGIC DRUGS

 

The recently enacted health care reform overhaul, the Patient Protection and Affordable Care Act (H.R. 3590) helps to establish a pathway by which generic biologic drugs, also referred to as biosimilars or follow-on biologics, can be safely and accurately developed and advanced to patients. Under the new law, biologics manufacturers will be granted 12 years of exclusivity before lower-cost generic versions can be developed.

The establishment of a pathway for generic biologic drugs is regarded by lawmakers as a means to address the high cost of prescription drugs and achieve health care savings. Biologics, also known as biopharmaceuticals, are expected to account for nearly half of all approved pharmaceuticals in the U.S. in the coming year or so. They are also among the most expensive drugs and are most commonly used for the treatment of patients with cancer. It is anticipated that by putting in place a framework to safely and accurately develop lower-cost biosimilar therapies, patients will benefit from the cost savings.

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  INTELLECTUAL PROPERTY/PATENT REFORM 

 

The role of patents in the development of pharmaceuticals is a topic of debate for policymakers. At issue is whether patents serve to drive innovation by ensuring that developers can ward off competition long enough to capture the full rewards of their work, or whether they actually hinder it by obstructing scientists from building and improving upon existing products or creating less costly alternatives.

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A report on gene patents and their impact on patient access to genetic tests.

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  PEDIATRIC ONCOLOGY

 

Cancer is the leading cause of death by disease among U.S. children. There are about 9,500 new cases of pediatric cancer each year, and the incidence of cancer in children is increasing and the causes are largely unknown. Greater investment and collaboration in pediatric research will accelerate the discovery of prevention strategies, treatments and cures for childhood cancers and adult cancers that begin early in life.

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RESEARCH WORKFORCE

 

The U.S. is in the midst of a severe oncology nursing shortage and on the brink of losing a generation of young investigators to more promising opportunities in other fields or overseas. Progress toward conquering cancer will significantly suffer without reviving our workforces and providing them the resources to produce new, innovative ideas that can compete on a global level. 

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An update of the 2005 report, "Rising Above the Gathering Storm," this report provides a snapshot of the work of the government and the private sector in the past five years, analyzing how the original recommendations have or have not been acted upon, what consequences this may have on future competitiveness and priorities going forward.

Report by researchers at Rutgers and Georgetown University suggests that the U.S. is producing an ample supply of high-achieving STEM graduates but failing to provide appealing career opportunities to retain them in those fields.

Report produced by seven concerned academic institutions warning that America stands to lose a generation of young researchers if current NIH funding trends continue.

Report detailing medical advances being made in academic research laboratories across the country that are threatened by NIH funding trends.

Report urging a comprehensive and coordinated federal effort to bolster U.S. competitiveness and pre-eminence in science and technology. It makes four recommendations along with 20 implementation actions that federal policy-makers should take to create high-quality jobs and focus new science and technology efforts on meeting the nation's needs.

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STEM CELL RESEARCH

 

Stem cell research holds the potential to improve the prevention, diagnosis and treatment of cancer. Peer-reviewed scientific evidence indicates that stem cells provide powerful models of the cellular and molecular origins of many cancer types. Continued experimentation with human stem cells is necessary to improve evaluation of anti-cancer drugs, to identify markers for early detection of cancer and to illuminate the path to novel, targeted treatments.

In early 2009, President Obama signed an executive order that overturned an eight-year-old policy that had restricted federal funds for embryonic stem cell research. By lifting the ban put in place by President Bush in 2001, the new order will allow researchers to apply for federal funds to study new stem cell lines.

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