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
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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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