What is the future of cancer Research or Treatments
the future of cancer research accelerating scientific innovation and what is the future of cancer research and philanthropic partnerships and the future of cancer research
HelenaColins,New Zealand,Professional
Published Date:06-07-2017
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The Future Of Cancer Research:
ACCELERATING SCIENTIFIC
INNOVATION
President’s Cancer Panel Annual Report 2010-2011
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer InstituteThis report summarizes the Panel’s findings and
Perceptions of Cancer Risk, Cancer
conclusions based on the testimony received
Research, and the National Cancer Program
and additional information gathered prior
to and following the meetings. The Panel’s
Perceptions and knowledge about cancer risk,
recommendations describe concrete actions that
the process and benet fi s of cancer research, and
participants in the National Cancer Program can
the NCP vary substantially not only among the
take to speed the development of advances that
general public, but within the medical and research
will propel the nation into a new era of cancer
communities, and among policy makers.
prevention and treatment.
According to the most currently available data, 1 in
Scope and Leadership of the National
2 men and 1 in 3 women—about 40 percent of the
Cancer Program
U.S. population—will receive a cancer diagnosis
(excluding basal/squamous cell skin cancers or
e N Th ational Cancer Act of 1971 (P.L. 92-218) created
in situ cancers other than in situ bladder cancer)
the National Cancer Program (NCP) and charged
at some point in their lives. Studies suggest that
the Director of the National Cancer Institute (NCI)
people often assess their comparative risk for a
with planning and coordinating the cancer activities
given danger to be lower than average—including
of NCI and the National Institutes of Health (NIH),
the risk of developing cancer—in part because
as well as cancer-related activities of other agencies,
they do not want to feel vulnerable. They also may
including those in the private sector. However, the
misperceive their risk for specic c fi ancers (e.g., risk
NCI Director was not given specic l fi egal authority
of lung cancer among smokers). Research further
to mandate or enforce actions to coordinate the
suggests that risk perception is inu fl enced by individuals’
NCP, and despite robust implementation plans in the
dic ffi ulty in using numbers and percentages.
early years following passage of the Act, subsequent
years saw the erosion of adherence to the planning
Public support for cancer and other biomedical
process. In 2012, more than 40 years after passage
research to improve health is strong, and surveyed
of the Act, neither the scope of the NCP nor its
Americans have stated that we do not spend
leadership, coordination, or participants have ever
enough and that basic, health services, prevention,
been clearly defined. As a result, the NCP lacks
and regulatory research are all important to
a national vision and priorities, and the cancer
controlling rising health care costs.
research effort continues to be fragmented and largely
uncoordinated. The application and dissemination
e N Th CP lacks a clear identity and national
of research advances remains uneven at best.
presence. Because it is neither fully defined in
statute nor a line item in the federal budget,
Participants in the National Cancer Program
it is poorly understood or supported by some
legislators. Similarly, many in the cancer research
In addition to the issues of leadership and
and care communities have only a vague notion of
coordination, the full complement of entities and
what the NCP encompasses.
constituencies—not just the research and clinical
enterprises—that are considered to be participants
Our National Cancer Burden
in the NCP remains unclear. It has long been the
Panel’s view that the NCP is not limited to cancer
In 2012, more than 1.6 million new cancer cases are
research and cancer care supported by government,
expected to be diagnosed in the United States, and
private, and voluntary sector entities. Rather, the
an estimated 577,000 Americans are projected to
Panel considers the NCP to also encompass the
die of the disease. In the coming decades, changes
activities of all other organizations, industries, and
in cancer rates related to demographic shifts in the
individuals whose actions inu fl ence the burden of
United States are expected to offset recent mortality
cancer in the United States.
reductions and result in a marked increase in the
ii President’s Cancer Panel Annual Report 2010-2011number of new cancer diagnoses made each year. of cancer. For example, the development and
Cancer is projected to become the nation’s leading increasing availability of high-throughput
cause of death—surpassing heart disease—over technologies have enabled the sequencing of the
the next decade as the U.S. population ages. Other human genome and led to the emergence of the
factors also challenge efforts to make progress so-called “omics”—genomics and proteomics, as
against the disease. Cancer is enormously complex well as the more nascent field of metabolomics. By
and highly adaptable; many subtypes of the disease providing comprehensive or near-comprehensive
have distinct clinical features and susceptibilities to snapshots of the molecular make-up of normal
therapy. Many cancers still are not diagnosed until and cancer cells, these approaches are enabling
they are at advanced stages, and some resist most systematic characterization of the pathways and
attempts at treatment. processes that are dysregulated in cancer.
Highlights of Cancer Research Progress Concern about the slow pace of progress against
cancer has led to an increasing recognition that
When the National Cancer Act was signed into law specic a fi ttention must be paid to the types of
in 1971 there was widespread optimism that the research activities needed to move findings from
signic fi ant expansion of support for cancer research laboratory and epidemiologic studies to clinical
would quickly yield cures. Unfortunately, progress testing and application. In many cases, the
against cancer has been far slower than anticipated. development of new technologies facilitates such
However, important advances have been made, translational research. For example, techniques
some of which have resulted in substantial clinical have been developed and refined in recent decades
benet f fi or patients. to facilitate preclinical research on promising
cancer targets and therapies.
Although research to prevent cancer has received
far less emphasis than treatment-oriented research, Clinical research in the areas of surgery,
it has nonetheless yielded several important chemotherapy, and radiation therapy also
benet fi s to date. Most notably, reduced mortality has contributed to important gains in our
due to lung and other tobacco-related cancers understanding of cancer and enhanced outcomes
(particularly among adult males) has been the and quality of life for many cancer patients.
direct result of intensive smoking prevention Among these achievements are less extensive and
and cessation efforts over the past few decades. image-guided surgical procedures; radiotherapy
Epidemiologic studies and basic research have technologies and regimens that treat the tumor
supported efforts to prevent cancer and have but spare normal tissue; and a growing number
contributed to recently observed overall reductions of targeted and personalized cancer therapies,
in cancer incidence and mortality rates. A considerable including vaccines.
amount of cancer prevention research has focused
on vaccines, with notable successes (e.g., human Cancer screening and early detection research has
papillomavirus vaccine/cervical cancer; hepatitis B improved understanding of the cancer screening
vaccine/liver cancer), as well as on other preventive needs of various populations, assessed the ec ffi acy
interventions (e.g., Helicobacter pylori testing and of available screening tests, and stimulated imaging
treatment of individuals at higher risk for gastric technology enhancements. At this time, however,
cancer). Other infectious agents, which have been population-wide cancer screening is available
associated with nearly 20 cancer types, are of for only four types of cancer—breast, cervical,
growing interest as targets of vaccines and other colorectal, and prostate—and most of these tests
preventive interventions. have notable weaknesses. Further, doubt has been
raised in recent years about the extent to which
Laboratory research over the past four decades has routine screening decreases cancer mortality and
led to signic fi ant advances in our understanding
President’s Cancer Panel Annual Report 2010-2011 iiiwhether the benet fi s of some types of screening all. The negligible growth rates are even more
outweigh possible harms. troubling when the increasing costs of conducting
biomedical research are taken into account.
Surveillance, epidemiology, and population-based Funding reductions and fluctuations not only
research provide information on the burden of constrain needed new research, but threaten
cancer and, in the past several decades have helped the success of research already under way, since
uncover numerous determinants of cancer risk and investigators cannot count on having funds needed
outcomes. These disciplines also can inform the to retain research staff and purchase materials.
direction of and/or build on the results of other Importantly, uncertain and reduced funding are
types of research, including basic, clinical, and discouraging the best young scientic m fi inds from
applied approaches. pursuing cancer research careers and quashing
the commitment of some seasoned investigators to
Modifying the Focus and Priorities of the remain in cancer or other biomedical research.
National Cancer Program to Accelerate
Innovation and Progress e p Th hilanthropic sector has consistently supported
cancer research in the decades since passage of
e e Th xtent to which research funders are willing the National Cancer Act. Although this sector
to accept risk (i.e., the possibility that a funded contributes only a small proportion of total cancer
research project may fail) in order to achieve research funding in the United States, its role
transformative innovation and progress lies at in fostering scientic i fi nnovation should not be
the heart of the NCP’s focus and priorities. In minimized. Unfortunately, charitable donation
the current era of constrained resources, most and other funding (e.g., from for-prot en fi tities)
research funders are sharply risk-averse. To shift levels in general have decreased, and the funding
the priorities of the NCP to strongly promote base for many nonprot o fi rganizations is in
innovation in cancer research and achieve more jeopardy.
rapid reductions in the national cancer burden,
action will be needed in several critical areas. Pharmaceutical companies have dramatically
increased their research programs since the early
Cancer Research Funding Trends 1970s. However, the ratio of R&D investment to
pharmaceutical sales, which rose dramatically in
Cancer remains the disease feared most by the 1980s, has gradually declined. In addition,
Americans, and the majority of Americans indicate the nature of R&D research conducted by
that accelerating research to improve health—as pharmaceutical companies has changed; over the
well as rein in rising health care costs—should past several decades investment in nonclinical and
be a top or high priority. Americans also are preclinical projects has suffered as more money
concerned that the United States is losing its is being spent on clinical trials and regulatory
global competitive edge in science, technology, expenses.
and innovation. Despite these widely shared
perspectives, funding for biomedical research in Research Areas with Limited Emphasis
the United States has stagnated in recent years.
A lack of consistent funding threatens investments Recognition is growing that the ongoing emphases
in innovation that are crucial to move beyond on basic and treatment research have occurred at
incremental advances in scientic k fi nowledge the expense of other types of cancer research, some
and prevention and treatment of diseases such of which could have more immediate effects on the
as cancer. Shifts in national priorities and an national and global cancer burden. Specic fi ally,
economic recession in recent years have created investments in translational, behavioral, and
an environment in which NIH and NCI annual population-based research are needed to expand
budgets have increased only marginally, if at upon the knowledge gained through basic
iv President’s Cancer Panel Annual Report 2010-2011and clinical investigations as well as inform ensuring that participant recruitment and selection
development of new interventions. is fair; and ensuring informed consent.
More emphasis also is needed on areas of the Recent actions represent important steps toward
cancer continuum beyond disease treatment, expanding prevention research and recognizing
including prevention and early detection research its importance not only in cancer, but in the
and the long-term and late effects of treatment nation’s health as a whole. Notably, in June 2011,
that often plague cancer survivors. An expanded the Department of Health and Human Services
understanding of the factors that inu fl ence cancer developed the first-ever National Prevention
risk and progression is critically needed. Although Strategy, as required by the Patient Protection
some investments in such research have been and Affordable Care Act (P.L. 111-148). Though
made, when compared with biology and treatment not limited to cancer prevention, the strategy
research, these areas continue to comprise a underscores the roles of virtually all federal and
much smaller component of the cancer research state/local agencies, private industry, and others
portfolios of most major funding organizations in reducing the burden of disease in the United
in the United States, Europe, and Canada. As a States. It also recognizes the potential savings—in
result, the knowledge base in these research areas health care costs, national productivity, and human
is less well developed, as are the range of tools and suffering—that can be achieved with investments
interventions that could be developed with a more in prevention.
robust research investment.
Changing the Focus of Biomarker Research
Making Prevention a Research Priority
e U Th nited States has made considerable
Testimony provided to the Panel emphasized that investments in cancer biomarker research, and
the best approach to reducing the national cancer this continues to be an area of intensive study.
burden is to prevent cancers from ever occurring. Hundreds of potential biomarkers have been
Most cancer research currently emphasizes discovered for possible use in drug development,
drug development and surgery to achieve tumor and for assessing cancer risk, likely treatment
shrinkage, improve disease management, and response, and actual treatment response. However,
develop salvage therapies for advanced cancers. most of the markers identified to date have yet to
Although treatment advances are needed, a be tested suc ffi iently, or at all, to determine their
markedly greater emphasis on cancer prevention, specic fi ity and sensitivity in clinical settings.
early detection, and early intervention is crucial to
reducing the national cancer burden. Greater emphasis is needed on validating the
diagnostic and early-detection utility of biomarkers
Active areas of research related to cancer that have been identified compared with current
prevention have included vaccine development (e.g., emphasis on new marker discovery. Some markers
human papillomavirus vaccine for cervical and already discovered may turn out to be of little or
other HPV-linked cancers) and chemoprevention, no clinical value. At the same time, new markers
such as the use of tamoxifen to prevent second continue to be needed in underdeveloped areas.
cancers in breast cancer survivors. While there
have been successes, clinical trials and intervention Managing Cancer as a Chronic Disease
development in this area have been hindered by
numerous ethical concerns about administering Until quite recently, cancer treatments focused
drugs with potential side effects to ostensibly almost exclusively on total and permanent
healthy, asymptomatic individuals. Such issues eradication of disease (i.e., cure) through the use
include weighing anticipated social benet a fi nd of surgery, escalating doses of cytotoxic agents,
risks; defining the risk status of study participants; and radiation. Achieving this goal with some
President’s Cancer Panel Annual Report 2010-2011 vconsistency, however, has been possible in only One speaker noted that thousands of cancer
a small number of cancer types (e.g., thyroid, researchers are studying specic e fi vents (e.g.,
testicular, cervical) and generally only when the cellular transformation, metastasis), biochemical
disease is detected and treated in its early stages. processes (e.g., cell signaling), or other tightly
For most cancer types, cure has been elusive. defined aspects of cancer. However, this work is
Containing cancer growth and spread for long not taking place in the context of a systems model
periods of time has likewise proven to be extremely of the problem, with researchers working in a
dic ffi ult, since most cancers become resistant to coordinated fashion (ideally in multidisciplinary
available therapies. teams) toward a common goal of creating and
implementing clinically effective solutions.
Key challenges in managing (rather than
eradicating) cancer are to enable patients to live Rethinking Research Processes to
with no or minimal symptoms of disease and avoid Accelerate Progress and Encourage
morbidity due to toxicities that may be induced Innovation
by long-term continuous or periodic maintenance
treatment. Achieving these objectives would be Established research processes and related
aided signic fi antly if aggressive and more indolent actions—including grant application and peer
tumors could be better distinguished, since it review mechanisms, publication preferences
might be possible to treat less aggressive cancers of scientic j fi ournal editors, and disincentives
less frequently or with lower drug dosages. It can to participating in team science and multi-
reasonably be anticipated that with continued institutional collaborations—discourage
research, effective cancer management approaches innovation and slow progress against cancer.
will become available to enable patients with To enable the transformative research advances
diverse cancer types to survive for many years that will accelerate patient outcome improvements,
with a good quality of life. these processes need to be reconsidered and
redefined to identify problems and establish
Taking a Systems Approach to Cancer Treatment more productive approaches.
A systems biology approach is needed to Adopting Grant Application, Peer Review, and
understand cancer in the context of the whole Funding Models that Encourage Innovation
patient, i.e., shifting from a tumor-specic f fi ocus
to one that is person-specic fi . Cancer exists not in Numerous aspects of the NIH grant application and
isolation but as part of a hugely complex system— funding process discourage innovation. The lag
the human body. A key problem in cancer research between application submission, award notic fi ation,
as it is conducted today is the predominance of a and receipt of funding still is exceedingly long,
point approach rather than a systems approach. despite recent attempts to streamline the process.
Measuring the status of a patient’s tumor or his/her e Th se delays may jeopardize the ability of principal
symptomology at a single point in time is of limited investigators to hire and retain key research staff
value. Tools are needed to enable continuous and avoid interruption or cessation of laboratory
monitoring to detect system changes well before or clinical operations. Young scientists are
they exhibit as symptoms, thereby permitting more particularly disadvantaged in the NIH grant
rapid intervention to improve system function. application and peer review process, which favors
In addition, clinicians must have a framework established investigators over young scientists
for evaluating and using the data generated by who could bring fresh perspectives to answering
such tools. The goal should be health, not tumor important cancer research questions.
shrinkage.
vi President’s Cancer Panel Annual Report 2010-2011Bolstering Drug Development
Other research models have been designed
specic fi ally to encourage and fund innovative
Pharmaceutical agents have made signic fi ant
studies that hopefully will have a transformative
contributions to the progress made against cancer
impact on knowledge in a given field and
in the past several decades as well as in efforts to
subsequently benet t fi he population. Underlying
optimize the quality of life of cancer patients and
all of these funding mechanisms is the critical
survivors. New drugs will be integral to future
recognition that studies exploring innovative ideas
preventive and treatment strategies; however, drug
tend to have a higher failure rate than lower-risk
development is expensive and fraught with risk.
projects aimed at incremental advances. In these
According to some analyses, only 2 in 10 approved
funding models, however, such failures do not
medications—cancer and noncancer combined—
ree fl ct negatively on the researcher, since much can
produce revenues that exceed average R&D costs.
be learned from well-designed experiments that do
u Th s, ongoing investment in R&D depends on the
not yield expected results.
commercial success of a few products that must
recover their own development costs and also make
Ensuring Publication of Study Results
up for all of the rest, including those that never reach
the market.
Publication of negative or inconclusive research
results is rare. In many cases, such studies may not
Cancer drugs comprise a substantial portion of the
even be submitted for publication, because they
drugs in the pipelines of pharmaceutical and biotech
do not enhance the stature of the investigator. In
companies. Although the R&D investment in
addition, scientic j fi ournals historically have had
anti-cancer drugs is substantial, it is associated with
little interest in publishing negative results; of such
considerable risk. The cancer drug market is smaller
studies that are submitted for publication, many
than those for chronic conditions such as diabetes and
are rejected. As a result, unsuccessful studies are
hypertension and the discovery of disease subtypes
needlessly repeated, a waste of both economic and
continues to shrink the pools of patients that may
human resources. In addition, not publishing
benet f fi rom a particular drug regimen. In addition,
null or negative findings increases investigators’
cancer drugs have a higher failure rate in Phase III
disincentive to take on higher-risk studies that may
trials than do drugs in other therapeutic areas, aer ft
fail because their career advancement depends
substantial R&D dollars have been invested.
heavily on the number of papers they publish.
e Th se dynamics are a function of the current
Reimagining the Clinical Trials System—
academic culture.
Need for a New Paradigm
Inec ffi iencies in the current clinical trials system
undoubtedly contribute to suboptimal oncology
drug development. Recent analyses have shown
that the process of activating a clinical trial is long
and tedious. One study found that it requires a
median time of approximately 2.5 years to open a
Phase III clinical trial sponsored through the NCI
Clinical Trials Cooperative Group Program, with
some trials taking more than four years to achieve
activation. Unfortunately, trials still face dic ffi ulty
once activated. A large percentage of cancer
clinical trials do not accrue adequate numbers
of patients, and some fail to enroll even a single
patient. A signic fi ant number of cancer clinical
President’s Cancer Panel Annual Report 2010-2011 viitrials are never completed. Failure to complete design of Phase II trials that more accurately
trials may not only delay or prevent potentially predict success in Phase III trials, since Phase III
benec fi ial interventions from reaching patients, trials account for more than two-thirds of the cost
but also has troubling financial and ethical of the clinical trials process. A number of ideas for
implications because of the investment of resources more effectively and ec ffi iently testing interventions
and involvement of patients in trials that do not for cancer have been proposed, including
yield meaningful information. consideration of nontraditional endpoints and
use of adaptive trial designs. Also important are
Many speakers who gave testimony to the Panel efforts to ensure that clinical and demographic
emphasized the need for the NCP to revisit the characteristics of participants in cancer clinical
ways in which oncology trials are designed, trials are representative of the overall population
implemented, and regulated to better meet the of cancer patients.
challenges created by advances in understanding
of the molecular and genetic bases of cancer. Addressing Challenges Related to Institutional
Review Boards (IRBs) and Other Regulators
Addressing Organizational and
Operational Issues Researchers are largely supportive of the goals of
IRB review and most recognize the need for an
Several recent studies have evaluated the oversight system, but many express frustration
organization of and processes necessary to develop, with the current implementation of IRB review
launch, and conduct NCI-sponsored trials. These processes. Preparing IRB submissions is time
analyses identified organizational inec ffi iencies consuming and requested revisions also take
and hundreds of discrete steps and decision points time, often without adding signic fi ant value to
required for trial activation, many of which appear the protocol. The burden of IRB review and the
to add little or no value to the process. NCI has associated research costs and delays are amplified
initiated several activities in an effort to address the in multicenter studies that require review and
organizational and operational inec ffi iencies in its approval by IRBs at each site. Cancer clinical
clinical trials system. Many of the changes under trials also are overseen by several agencies within
way are aligned with recommendations set forth the U.S. Department of Health and Human
in the 2010 Institute of Medicine report on the Services that have different objectives and
NCI Clinical Trials Cooperative Group Program responsibilities and thus require different reporting
as well as those in the 2005 report issued by the and compliance actions. The claim that current
NCI Clinical Trials Working Group. regulatory processes result in unnecessary resource
expenditures warrants attention, but perhaps more
Designing Ee ff ctive Trials troubling is the contention that the regulatory
burden leads researchers to avoid certain types of
Researchers are recognizing the need to more research, particularly projects that involve multi-
quickly and accurately differentiate promising institutional collaboration.
agents from unsafe or ineffective drugs and
determine which patient populations are most
likely to benet f fi rom specic d fi rugs. An analysis
of major pharmaceutical companies in the United
States and Europe found that only about 1 in 9
drugs that are taken into first-in-human studies
are eventually approved; the rate is even lower for
oncology drugs, which achieve approval in only
five percent of cases, according to one estimate.
A major challenge in drug development is the
viii President’s Cancer Panel Annual Report 2010-2011Promoting Productive Team Science,
Strengthening the Cancer Research
Multi-Institutional Collaborations, Consortia,
and Care Workforce
and Partnerships
e c Th oming years hold extraordinary promise
Many of the challenges facing the cancer research
for improving our understanding of cancer and
community cannot be adequately addressed by
learning to prevent it, find it early when it does
individual researchers in isolation but require teams
occur, and treat all forms of the disease effectively
with varied expertise and resources. The shi ft
without signic fi ant side effects. Yet without a
toward collaborative science was illustrated by a
talented, innovative, and diverse workforce of
recent study that found that high-impact research
researchers and clinicians, these much-needed
is increasingly being published by teams rather
advances cannot become reality.
than individuals. Collaborative scientic e fi fforts
may take several forms, including interdisciplinary
e U Th nited States is facing critical shortages both
team science projects, multi-institutional
in its research workforce and in the physician
collaborations, consortia, and partnerships. These
and nonphysician clinical workforce. It will not
activities—which can involve international as well
be suc ffi ient merely to maintain current levels of
as U.S. participants—bring together people and
research and clinical capacity. Shortages in the
organizations from different sectors and diverse
cancer care workforce are of great concern because
disciplines to address a key scientic q fi uestion or
they will diminish both access to and quality
problem, develop needed resources or technologies,
of care for people with cancer and may increase
accelerate drug development, or conduct
the burden on families of cancer patients and
community-based research. There is, however, a
survivors.
need for new methods and measures to evaluate the
processes and outcomes of large research endeavors.
Meeting the cancer research and care workforce
demands of the coming decades will require
Fortifying the Research Infrastructure to
creativity, foresight, and tenacity on the part
Support Transformative Innovation
of all stakeholders: government, academic
institutions, scientic a fi nd medical societies,
Major technological advances in science made
cancer advocates, quasi-governmental and private
in the past decade (e.g., “-omics,” computational
health policy organizations. Both components
chemistry, data-sharing capacity, digitization
of the cancer workforce will be crucial to making
of scientic i fi nformation) have not yet had a
the transformative discoveries needed to reduce
revolutionary effect on clinical care or clinical
America’s cancer burden and ensuring that all
outcomes. Aspects of the cancer research and
people with or at risk for cancer benet e fi qually
care infrastructure that warrant attention include
from these discoveries.
the need to upgrade research facilities; further
develop technologies such as imaging, data
Accelerating Health Care Delivery System
systems, and data-sharing; and expand the utility
Improvements for Better Patient Outcomes
of biorepositories. With further development and
support, these technologies have tremendous
Several health care system characteristics
potential to advance the cancer research and care
discourage innovation in care, with upstream
agenda.
effects on translational and clinical research.
e Th se system weaknesses—such as fragmented,
uncoordinated care and inequitable distribution
of services—may have a negative impact on health
outcomes both broadly and specic fi ally for cancer
patients/survivors.
President’s Cancer Panel Annual Report 2010-2011 ixBarriers to Health Care Delivery System Technological Advances with Potential to
Improvements Revolutionize Health Care Delivery
Although the United States has a wealth of health Several tools and technologies—ranging from
care resources, patient outcomes for most conditions electronic health record systems to smart
lag behind those of other developed nations. phones—have the potential to enable health care
Several health care delivery issues contribute to professionals and consumers to record, access, and
this situation. One important example of these exchange information that can protect or improve
problems is the lack of consistency, appropriateness, health. To be effective, however, these tools must
and equity in the application of evidence-based be thoughtfully developed and applied. Health
cancer prevention, screening, and care services information technologies and electronic health
across all populations. Patient care oen i ft s highly records, for example, have potential to increase the
fragmented and poorly coordinated, as health ec ffi iency, cost-effectiveness, quality, and safety of
services have become increasingly specialized and medical care. In addition to directly benet fi ting
payment arrangements more complex. For patients patient care, such technologies can support crucial
with severe or multiple health conditions who take surveillance and research because data can be
numerous prescription medications, as is the case for aggregated and analyzed to gain insight into factors
many people with cancer, this fragmentation of care that inu fl ence health and disease.
can be especially hazardous.
Accelerating Scientific Innovation:
Another stumbling block to the prompt delivery Conclusions and Recommendations
of cancer care advances is a lack of effective
communication about cancer with key audiences. To expand and capitalize on knowledge and
Education and communication about cancer technology advances achieved to date, the cancer
continue to become more sophisticated and targeted, research community now must identify and
and successes, such as tobacco use prevention, embrace strategies for accelerating the pace of
illustrate the value of skills and information gained scientic i fi nnovation. Only by encouraging and
through health communications and related rewarding innovation and collaboration will
research that promotes dissemination of cancer critically needed transformative advances in cancer
research advances. prevention and treatment be achieved.
Improving Health Care Coordination, Based on testimony received and additional
Efficiency, and Quality exploration of these issues, the President’s Cancer
Panel has reached the following conclusions;
Numerous health service delivery innovations are these conclusions are followed by the Panel’s
being tested to improve health care coordination, recommendations for addressing barriers to
ec ffi iency, and quality in the United States. more rapid research progress and to signic fi ant
One such initiative specic t fi o cancer is the reductions in the burden of cancer on this nation.
development of patient navigation programs to
assist patients in locating needed services and
managing appointments across disconnected care
settings. Written cancer treatment summaries
and survivorship plans, which can help patients
document the cancer care they receive and plan the
continuing care they will need following treatment
and throughout their lives, also are important
tools to support improved care coordination,
communication, and ec ffi iency.
x President’s Cancer Panel Annual Report 2010-2011transformative innovation in cancer research
Conclusions
that can lead to markedly improved outcomes for
patients.
Sustained Investment in Basic Science
Research Is Essential to Further Increase
Expanded Research Could Lead to More
the Understanding of Cancer
Eec ff tive Long-Term Management of Cancer
Basic research will always be needed—it is the key
as a Chronic Disease
to transformative discoveries about fundamental
cancer biology, the mechanisms by which cancer
Cancer may never be eradicated entirely, but some
develops and spreads, and how it may be prevented.
cancers can now be managed effectively with
Basic science discoveries may find innovative
ongoing or intermittent treatment, as is possible
application both in cancer and in other areas of
with certain other chronic diseases (e.g., diabetes).
health care.
Increased research to improve disease control and
symptom management would enable people with
Support for High-Impact Research Is Necessary
cancer to live more productively and with a good
to Drive Transformative Change in Cancer
quality of life.
Prevention and Care
Funding instability is a critical barrier to scientic fi Publication of Null or Negative Research
innovation. Moreover, high-risk research with the Findings Is Critical to Scientific Progress
potential to result in transformative innovation and
Negative and null study results are seldom
research aimed at making incremental progress
published due principally to investigator career
currently compete for the same funds. Incremental
concerns and low interest among scientic j fi ournal
research is safer and will pull dollars away from
editors. Failure to publish such findings robs
innovative ideas in a risk-averse climate.
the scientic c fi ommunity of useful information
that would inform subsequent research, prevent
e A Th cademic Research Culture Should
needless waste of resources, and accelerate
Emphasize the Impact of Investigators’
progress. This information also could help cancer
Research on Disease Burden
patients and their caregivers make more informed
e r Th isk-averse academic research culture and treatment or other cancer-related decisions.
its structures (promotion and tenure criteria and
processes) continue to discourage innovation and e B Th est Approach to Reducing the Nation’s
collaboration. Rewards continue to be aligned Cancer Burden Is to Prevent Cancers from
primarily with independent research projects and Occurring
the number of papers a scientist publishes rather
than encouraging collaboration and acknowledging Current research and health care delivery
the impact of a researcher’s work in reducing the emphasize overwhelmingly the treatment of acute
cancer burden. disease rather than protection and preservation of
overall health. Acute, episodic care is inec ffi ient,
Reden fi ed Grant Review Mechanisms and expensive, and dic ffi ult for patients. Preventing
Novel Research Funding Models Have cancer is the best and most cost-effective way to
Significant Potential to Speed the Translation reduce cancer incidence, mortality, and morbidity
of Scientific Discoveries into New Standards and associated human, health system, and national
of Cancer Care productivity costs. It is time for the research
community and policy makers to recognize and
Innovative research models; streamlined and
embrace cancer prevention as one of the foremost
blinded application and review processes; and grant
goals of future cancer research.
mechanisms that reward innovation and disease
impact all have signic fi ant potential to accelerate
President’s Cancer Panel Annual Report 2010-2011 xiTeam Science and Collaborative Research Community Involvement in Research Design,
Initiatives Provide Opportunities to Address Implementation, and Analysis Enhances the
Complex Cancer Research Challenges Relevance of Clinical Research
Public-private partnerships hold enormous Consumer/community perspectives and expertise
potential for increasing translational research continue to be underutilized both in clinical
investments and maximizing productivity in a trial and other research design and in study
resource-limited environment. Team science implementation and analysis.
efforts also provide opportunities to bring
nontraditional disciplines (e.g., engineering, Advances in Cancer Prevention and Care
behavioral and social sciences) to bear on cancer- Will Not Be Achieved Without an Adequate
related problems. Research and Clinical Workforce
Unless current and impending research and clinical
A Redesigned Clinical Trials System Has the
workforce shortages are remedied, it will not be
Potential to Improve and Accelerate Oncology
possible to make the gains in new knowledge and
Drug Development
patient outcomes that are possible in the coming
e e Th xisting clinical trials paradigm is outdated years.
and inec ffi ient. Traditional trial designs often
are not well suited for testing emerging targeted Eo ff rts Under the National Cancer Program
therapies and combination regimens. In addition, Are Fragmented and Largely Uncoordinated
due to the lack of an effective prioritization system,
e N Th ational Cancer Program continues to be
scarce resources and patients often are devoted to
poorly defined and lacks both a national vision
the conduct of trials likely to yield only incremental
and a set of principles, priorities, and strategies
knowledge and/or benet t fi o patients. Drugs with
for realizing substantial reductions in the burden
potential to improve the outcomes of patients with
of cancer borne by the American public. This
early-stage disease may be overlooked because of
ongoing dec fi it leads to research and patient care
the disproportionate focus of oncology trials on
inec ffi iencies and redundancies and a lack of
advanced disease.
accountability of some stakeholders.
Major Technological Advances in Science Have
Not Yet Had a Revolutionary Eec ff t on Cancer
Clinical Care or Outcomes
Imaging technologies, electronic health record
and other data systems, biorepositories, and
communication technologies hold enormous
promise for advancing the cancer research and care
agendas and expanding community participation
in research but need stronger support for their
continued development and application.
xii President’s Cancer Panel Annual Report 2010-2011Recommendations
Recommendation Responsible Stakeholder(s) and Other Entities
1. Within fiscal limitations necessary during the nation’s
Congress
economic recovery:
Department of Health and Human Services
a. Support for basic research should remain strong, but
• National Institutes of Health
funding must be better balanced to provide greater
support for translational, clinical, epidemiologic, • Centers for Disease Control and Prevention
behavioral, and health services research.
• Centers for Medicare and Medicaid Services
b. Of special importance, cancer research should shift its
• Agency for Healthcare Research and Quality
focus and funding across the research continuum
strongly toward cancer prevention, including prevention
• Health Resources and Services Administration
of exposure to known carcinogens and understanding
Department of Defense
of the role of infectious agents in cancer causation and
progression.
Veterans Administration
c. Strategies must be devised to stabilize research
Other public sector cancer research sponsors
funding overall and overcome the risk aversion of
Private and voluntary sector cancer research
cancer research sponsors, which discourages
sponsors
innovative research.
2. Grant review mechanisms should be revised to encourage
Department of Health and Human Services
innovative research models, streamline application
• National Institutes of Health
procedures, and adopt blinded peer review processes.
Funding strategies should be developed that will accelerate • Centers for Disease Control and Prevention
new discoveries and their more rapid translation and
• Food and Drug Administration
assimilation into standards of cancer care.
• Centers for Medicare and Medicaid Services
Department of Defense
Veterans Administration
Other public sector cancer research sponsors
Private and voluntary sector cancer research
sponsors
3. e a Th cademic research culture and its structures should
Public and private academic research organizations
be modified to more strongly encourage and reward
Scientic a fi nd medical journal editors
collaboration and measurable positive impact on the national
cancer burden in addition to continuing to reward basic
science discoveries by individuals.
The Panel recognizes that entities other than those listed may have a vital role or interest in implementation of the recommendations.
President’s Cancer Panel Annual Report 2010-2011 xiiiRecommendation Responsible Stakeholder(s) and Other Entities
4. Collaborations and partnerships, particularly between public Department of Health and Human Services
and private sector organizations, that address questions
• National Institutes of Health
related to cancer research and care should be actively
• Centers for Disease Control and Prevention
promoted, nurtured, and monitored. Collaboration with
nontraditional disciplines (e.g., engineering, mathematics,
• Food and Drug Administration
anthropology) should be encouraged.
• Centers for Medicare and Medicaid Services
Department of Defense
Veterans Administration
Other public sector cancer research sponsors
Private and voluntary sector cancer research
sponsors
Pharmaceutical and biotechnology industries
Department of Health and Human Services
5. Clinical trials with potential for signic fi antly improved
outcomes or transformative change should have the highest
• National Institutes of Health
priority; trials that are expected to demonstrate or confirm
• Food and Drug Administration
small incremental improvements should be discouraged.
Department of Defense
Innovative clinical trial designs with sound intermediate
endpoints and patient protections should be developed and
Veterans Administration
implemented to save research dollars and more rapidly
Other public sector cancer research sponsors
answer key research questions. To a greater extent than
currently is the case, drug trials should target early-stage Private and voluntary sector cancer research
sponsors
disease.
6. Widely available consumer technologies (e.g., cell phones,
Department of Health and Human Services
Internet, social media) should be incorporated into strategies
• National Institutes of Health
for cancer communication, health literacy enhancement,
• Centers for Disease Control and Prevention
outreach, navigation, patient-provider interface, and disease
management, particularly for rural and other underserved
• Food and Drug Administration
populations.
• Centers for Medicare and Medicaid Services
Department of Defense
Veterans Administration
Public relations, health communication, and
telecommunications communities
Behavioral and social scientists
Public and private sector health care institutions
and providers
Universities and colleges
Public health departments
The Panel recognizes that entities other than those listed may have a vital role or interest in implementation of the recommendations.
xiv President’s Cancer Panel Annual Report 2010-2011Recommendation Responsible Stakeholder(s) and Other Entities
7. e d Th evelopment and application of innovative imaging
Department of Health and Human Services
and other technologies with potential to accelerate progress
• National Institutes of Health
in cancer research and care should be strongly supported.
• Food and Drug Administration
Department of Defense
Other public sector cancer research sponsors
Private and voluntary sector cancer research
sponsors
Biotechnology and medical device industries
Department of Health and Human Services
8. Data sharing and transparency must be improved and
adequately supported. Specic fi ally:
• Oc ffi e of the National Coordinator for Health
Information Technology
a. Electronic health records adoption is a necessity, not
an option. Additional incentives must be developed
• National Institutes of Health
to encourage and enable EHR acquisition and
• Centers for Disease Control and Prevention
implementation across the range of practice settings.
Privacy and interoperability issues must be addressed
• Food and Drug Administration
more aggressively.
• Centers for Medicare and Medicaid Services
b. Reporting of negative and null study results
should be required by public, private, and other Department of Defense
nongovernmental funders. The information should
Veterans Administration
be made available via a free, online, open-access
Other public sector cancer research sponsors
journal or database.
c. Data collected about a population/community
Private and voluntary sector cancer research
must be provided in full to that population. The
sponsors
participation in research of consumer communities
Health insurance industry
that are interested in and willing to provide data and
biospecimens should be welcomed. Scientic a fi nd medical journal editors and
publishers
d. Coordination of biospecimen collection, annotation,
storage, and sharing must be standardized,
Cancer patient/survivor advocates and consumers
systematized, and expanded.
The Panel recognizes that entities other than those listed may have a vital role or interest in implementation of the recommendations.
President’s Cancer Panel Annual Report 2010-2011 xvRecommendation Responsible Stakeholder(s) and Other Entities
Department of Health and Human Services
9. e v Th iews and participation of cancer patient/survivor
advocates and other consumer representatives should be
• National Institutes of Health
sought during clinical trial and other study design, and
• Centers for Disease Control and Prevention
in developing and implementing public, professional,
and patient education and community-based research
• Food and Drug Administration
interventions.
• Centers for Medicare and Medicaid Services
Department of Defense
Veterans Administration
Other public sector cancer research sponsors
Private and voluntary sector cancer research
sponsors
Academic and other medical centers
Public health departments
10. A coordinated program of targeted actions must be Department of Health and Human Services
undertaken to recruit, retain, diversify, and grow
• National Institutes of Health
the cancer research and cancer care workforce.
• Centers for Disease Control and Prevention
Specic fi ally:
• Food and Drug Administration
a. Efforts to attract young people to careers in science
and medicine must be increased and should begin
• Centers for Medicare and Medicaid Services
at the K-12 level.
Department of Education
b. Support for young investigators must be increased
Department of Labor
to ensure the development of the next generations
of cancer researchers, including behavioral, health
Other public sector cancer research sponsors
services, population, epidemiologic, translational,
Private and voluntary sector cancer research
clinical, and basic scientists. Translational and
sponsors
physician-scientists, whose education and training
Academic and other cancer centers and
is of especially long duration, are particularly in
medical centers
need of training support.
Nursing and other nonphysician medical
c. Federal support for graduate medical education
educational institutions
should not be reduced, but rather increased.
State governments
Nursing and other nonphysician medical personnel
training and development initiatives established
by the Patient Protection and Affordable Care Act
should be fully funded and actively promoted.
Recruitment and retention initiatives of academic
and other medical institutions and physician
groups should be expanded to the extent possible.
d. Mentoring should be an integral part of research
and medical training at all levels.
e. Increasing the diversity of the cancer research and
cancer care workforce to more closely parallel that
of the population is essential.
The Panel recognizes that entities other than those listed may have a vital role or interest in implementation of the recommendations.
xvi President’s Cancer Panel Annual Report 2010-2011Recommendation Responsible Stakeholder(s) and Other Entities
11. e S Th ecretary of the Department of Health and Human e Th President
Services should be directed to convene a trans-HHS
e S Th ecretary, Department of Health and
working group to clarify the definition, mission, and
Human Services
vision of the National Cancer Program, define the
Department of Health and Human Services
principles and priorities for the NCP, and identify
• National Institutes of Health
strategies for improving coordination of NCP activities
to accelerate progress against cancer. The working
• Centers for Disease Control and Prevention
group should solicit input from the diverse community
• Food and Drug Administration
of stakeholders whose actions affect cancer patient
• Centers for Medicare and Medicaid
outcomes.
Services
• Agency for Healthcare Research and
Quality
• Health Resources and Services
Administration
The Panel recognizes that entities other than those listed may have a vital role or interest in implementation of the recommendations.
President’s Cancer Panel Annual Report 2010-2011 xviiPREFACE
The President’s Cancer Panel (PCP, the Panel), established by the National Cancer Act of 1971
(P.L. 92-218) is charged to monitor the development and implementation of the National Cancer
Program (NCP) and to report at least annually to the President of the United States on impediments
to the fullest execution of the Program.
Advances in biomedical science and revolutionary technologies have brought unprecedented
opportunities for increasing the depth and efficiency of scientific inquiry about cancer and other
human disease. Yet 40 years after declaring war on cancer, Americans still suffer cancer mortality
second only to the toll taken by heart disease. Understanding of the underlying genetic and biologic
mechanisms of cancer has grown rapidly, but translation of these insights into interventions that
effectively prevent and treat cancer has been painfully slow. Reductions in cancer mortality and
morbidity have likewise been slow and unevenly distributed among both the many types of cancer
and the diverse populations of this country. The need to find ways to significantly accelerate
scientific innovation and its application to reduce the burden of cancer is increasingly urgent as
the United States’ population ages and grows.To more fully explore barriers and opportunities for achieving research innovations with the power to
transform cancer care and dramatically improve patient outcomes, the Panel conducted a series of
meetings entitled, The Future of Cancer Research: Accelerating Scientific Innovation. Testimony was
received from 47 academic, industry, and public sector basic, translational, clinical, and population
science researchers and research program administrators; voluntary sector research sponsors;
health and science policy specialists; the cancer advocacy community; professional and industry
association representatives; and Federal Government regulators and administrators.
Four meetings were convened between September 2010 and February 2011 at the following locations:
Meeting Date Location
September 22, 2010 Boston, MA
October 26, 2010 Philadelphia, PA
December 14, 2010 Bethesda, MD
February 1, 2011 Atlanta, GA
In addition to verbal testimony, each speaker provided as part of the formal meeting record a
brief white paper expanding on his or her remarks. A roster of meeting participants is provided in
Appendix A. The recommendations in this report reflect the Panel’s conclusions based on all of the
testimony received, as well as on additional information gathered prior to and following the meetings.
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