Evaluating the Impact of Legislation and Informing Public Policy in Cancer Control
In 1971, a single piece of legislation changed how we view cancer care forever. The National Cancer Act cemented our nation’s commitment to science, establishing networks of cancer centers, clinical trials, data collection systems, and advanced research. In this 50th anniversary year of that landmark legislation, we look back at select examples of legislation that have played a pivotal role in enhancing our ability to alleviate the burden of cancer through research, and have laid the foundation for continued progress for the next 50 years.
American Recovery and Reinvestment Act (ARRA)
In 2009, Congress passed ARRA, which supported DCCPS work related to cancer prevention, screening, treatment, and genomics. FYs 2009 and 2010 saw an infusion of ARRA funding that enabled DCCPS to expand and enhance cancer research, helping to move exciting advances forward at an accelerated rate. DCCPS managed more than $187 million in ARRA funds to accelerate research and advance cancer control initiatives. ARRA funding enabled DCCPS to participate in some of the largest study populations ever assembled for cancer research, allowing the collection of new biospecimens and clinical data that continues to advance our understanding of the genetic architecture of cancer. ARRA was a catalyst for more than 65 studies of cancer susceptibility in human populations in seven NCI priority areas relevant to the fields of epidemiology and genetics. Using ARRA funding, DCCPS researchers helped collectively build a national clinical electronic data infrastructure that used prospective, patient-centered outcomes data and connected different clinical databases for comparative effectiveness research (CER), which provided a foundation for the PCORI-supported National Patient-Centered Clinical Research Network (PCORnet). ARRA appropriated significant funds to conduct and support CER, also called patient-centered outcomes research, which compares the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs about which interventions are most effective for which patients under specific circumstances. The division was responsible for more than $79 million in ARRA funds to support CER projects in cancer prevention, screening, and treatment, genomic and personalized medicine, and workforce development.
The Childhood Cancer Survivorship, Treatment, Access and Research (STAR) Act
In 2018, Congress passed the STAR Act as a comprehensive childhood cancer bill to advance pediatric and AYA cancer research and treatments, improve cancer surveillance, and enhance resources for survivors and their families. The STAR Act authorizes improvements to biospecimen collection and associated infrastructure, registry infrastructure, and research to improve the care and quality of life for cancer survivors, including children and AYAs. DCCPS issued an FOA to efficiently implement major elements of the STAR Act by funding multiple intervention research project grants beginning in FY 2019. The “Improving Outcomes for Pediatric, Adolescent and Young Adult Cancer Survivors” RFA focused on stimulating the scientific development of effective, feasible, and scalable interventions to address biomedical, behavioral, and psychosocial adverse effects in pediatric and AYA survivors of cancers. The development of interventions to address health disparities and the needs and preferences of minority or other medically underserved populations are of high priority in all research areas. These efforts were extended with a subsequent RFA funded in FYs 2021 and 2022, “Research to Reduce Morbidity and Improve Care for Pediatric and AYA Cancer Survivors,” which includes observational, mechanistic, and intervention studies and aims to comprehensively address all six STAR Act domains (stated in Sec. 202 of the STAR Act) for pediatric/AYA cancer survivorship research.
Childhood Cancer Data Initiative
The CCDI is a federal investment of $50 million proposed to be extended in equal amounts per year for 10 years. The first year of the initiative was funded in December 2019. These funds allow NCI to enhance data sharing, collection, analysis, and access for ongoing and planned childhood and AYA cancer and survivorship research throughout the institute. DCCPS researchers were involved in the NCI CCDI Symposium in July 2019 that convened scientific stakeholders and leaders from academia, government, industry, and advocacy organizations to develop more efficient and more effective means of collecting, analyzing, and sharing the data needed to speed progress against cancers that occur in children and AYAs. In June 2020, DCCPS participated in an ad hoc NCI working group convened to provide general guidance regarding future priorities for the initiative, including the issuance of a report of 24 specific recommendations to leverage data science and data sharing opportunities. The CCDI extends NCI’s ongoing support of childhood and AYA cancer research, as well as complements efforts authorized by two pieces of federal legislation: The STAR Act and the Research to Accelerate Cures and Equity (RACE) for Children Act.
The Cancer Moonshot to accelerate cancer research aims to make more therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage. In 2016, Congress passed the 21st Century Cures Act, authorizing funding for the Cancer Moonshot over 7 years. To ensure that the Cancer Moonshot’s approaches are grounded in the best science, the Cancer Moonshot Task Force established a Blue Ribbon Panel of experts to make transformative research recommendations to accelerate progress against cancer. To date, NCI has invested over $1 billion in Moonshot funding, supporting over 240 research projects across more than 70 cancer science initiatives. That investment has led to many important insights tied to the Moonshot’s key research priorities. DCCPS has a lead responsibility at NCI in a number of priority areas identified by the Blue Ribbon Panel, including engaging patients to contribute their tumor profile data; reducing cancer risk and cancer health disparities through approaches in development, testing, and broad adoption of proven prevention strategies; collecting, sharing, and analyzing patient cancer data to predict future patient outcomes; and implementation science. In FY 2020, DCCPS was responsible for nearly 30% of total NCI Moonshot commitments, and over the course of the 7 years, DCCPS will have been responsible for nearly 20% of total NCI Moonshot commitments across over 20 initiatives.
Tobacco Regulation and Related Tobacco Control Research
DCCPS’s TCRB within BRP leads and collaborates on research and disseminates evidence-based findings to prevent, treat, and control tobacco use in order to create a world free of tobacco use and related cancer and suffering. DCCPS’s work informs numerous areas of tobacco prevention and control-related policy. TCRB funded the State and Community Tobacco Control Research Initiative from 2011 through 2017. Through this initiative, NCI supported both observational and interventional studies that addressed tobacco use and exposure in the United States while also examining the effectiveness of state and community tobacco control policy and media interventions. Funded projects focused on research in five areas: tax and pricing policies, secondhand smoke policies, mass media countermeasures, community and social norms, and tobacco industry marketing and promotion.
The landmark Family Smoking Prevention and Tobacco Control Act of 2009 granted the FDA authority to regulate the manufacturing, marketing, and distribution of tobacco products. Evidence generated by DCCPS-funded research has contributed to FDA’s ability to make informed decisions as it determines how to implement its regulatory authorities. The TCORS are made up of investigators with a broad range of expertise (including epidemiology, economics, toxicology, addictions, and marketing) who conduct research projects around an integrative theme. In 2018, nine centers received funding. NCI programmatically manages four of the nine TCORS 2.0 sites.
DCCPS-funded research has shown that smokefree laws benefit nonsmokers by eliminating exposure to tobacco smoke and benefit smokers by providing an environment that encourages and facilitates quitting. As of April 2020, 36 states, Washington, DC, and Puerto Rico had enacted comprehensive smokefree laws. Several of the US territories also have enacted comprehensive smokefree laws. DCCPS scientists participate on a federal interagency workgroup (comprising the US Department of Housing and Urban Development [HUD], CDC, NCI, and the Environmental Protection Agency), which has convened regularly since 2013 to share current research, disseminate the evidence base, discuss local-level implementation, and encourage the use of evidence-based smoking cessation resources as part of all implementation efforts. Since HUD adopted a policy to prohibit smoking in public housing in 2016, this workgroup has continued to identify opportunities for collaboration between the Department of Health and Human Services (HHS), HUD, and other federal agencies to promote effective implementation of the rule in public housing. These agencies monitor and support implementation and evaluation of the HUD smokefree rule with the goal of protecting all people living in multi-unit housing.
Selected Examples of the Division’s Role in Informing Health Policy
DCCPS supports science that helps inform policies and programs aimed at preventing, detecting, and treating cancer and improving outcomes for cancer survivors. That science includes work to understand and assist those living with a history of cancer, as well as their families. A key focus of this work is evaluating the effect of models of care, incentives, and factors that can be changed to improve care. A portion of the research supported by DCCPS therefore provides policymakers with the practical evidence they need to make effective decisions. The division’s long-standing history of collaborating across NIH, HHS, and other agencies makes it uniquely suited to continue to play a role in the generation of evidence to shape and respond to national efforts to improve the value and effectiveness of cancer care. Below are select examples of the division’s research contributions related to public policy and illustrates its role in developing a comprehensive base of scientific evidence for policymakers and public health practitioners.
American Stop Smoking Intervention Study for Cancer Prevention (ASSIST)
ASSIST put into practice NCI’s commitment to prevent and reduce tobacco use across all populations and age groups. ASSIST took evidenced-based interventions from controlled studies and implemented them in 17 states that competed to participate in the initiative. Its underlying rationale — that significant decreases in tobacco use could be realized only with interventions that changed the broader social environment to ensure that social norms shifted to make tobacco use a nonnormative behavior — was a significant departure from previous tobacco control programs and in the vanguard of the “new” public health. Prior to ASSIST, very few states addressed tobacco use at the population level. DCCPS’s TCRB (and its precursor, the Public Health Applications Branch) led the ASSIST program, helping to develop a three-pronged intervention using policy development, mass media and media advocacy, and program services to change norms around children and smoking; smoking in public places; and state tax increases to reduce consumption and prevalence. The ASSIST legacy remains today in the tobacco control professionals whose work continues to reduce the burden of disability and death caused by tobacco.
State Cancer Profiles
The DCCPS 2020 Overview and Highlights highlighted the important work of implementation science to bridge the gap between research and practice to improve individual and population health outcomes. DCCPS recognizes that advances in our understanding of implementation processes will have maximum benefit if communicated in a way that supports and informs the important work of cancer control researchers and practitioners, providing them with the tools and resources necessary to help them better understand, plan for, and conduct rigorous D&I studies. One of those tools DCCPS works on is the State Cancer Profiles, a collaboration of NCI and the CDC. State Cancer Profiles supplies health planners, policymakers, and cancer information providers with data, maps, and interactive graphs to help guide and prioritize cancer control activities at the state and local levels. The site illuminates the cancer burden in a standardized manner to motivate action, integrate surveillance into cancer control planning, characterize areas and demographic groups, and expose health disparities. This invaluable tool generates interactive graphics and maps, which provide support for deciding where to focus cancer control efforts.
Dietary Guidelines and Physical Activity Guidelines
The DGAs are jointly issued and updated every 5 years by USDA and HHS. They form the basis for federal nutrition policy and provide authoritative and current evidenced-based dietary advice to promote health and reduce risk for major chronic diseases. DCCPS-supported researchers developed methodologies to estimate usual dietary intake distributions and identify sources of key dietary constituents, including added sugars; the resulting data have proven to be critical for the recent and upcoming versions of the guidelines. The 2020–2025 report includes the first-ever recommendations for Americans from birth through 24 months old, and DCCPS staff provided additional data analyses and methodological context for the committee for this population. In addition, DCCPS collaborated with USDA to develop the HEI, a measure of dietary quality that assesses conformance to the DGAs and has been used in hundreds of studies, including the evaluation of USDA’s multibillion-dollar food assistance programs.
The Physical Activity Guidelines for Americans (PAG), which serves as the primary, authoritative voice of the federal government for evidence-based guidance on physical activity, fitness, and health, was first issued by HHS in 2008, and the 2nd edition was released in 2018. DCCPS-supported data resources and analyses led to changes in the 2018 Physical Activity Guidelines for Americans, such as the removal of the requirement that activity had to occur in episodes of at least 10 minutes to count toward meeting the guidelines. In 2013, the Physical Activity Guidelines for Americans Midcourse Report: Strategies to Increase Physical Activity Guidelines Among Youth was published to provide evidence-based actionable steps to increase physical activity. DCCPS staff were involved in development of all these documents, as well as Step It Up! The Surgeon General’s Call to Action to Promote Walking and Walkable Communities and the Let’s Move! initiative.
In addition to these initiatives, DCCPS supports a wide range of research to help inform ongoing public health efforts across the US and the world. The DCCPS research portfolio includes studies aimed at understanding behaviors and barriers, along with effective interventions to increase the availability of places to be physically active and of healthy food in the home, at schools, in childcare settings, in neighborhoods, and in communities. DCCPS has supported research on topics related to obesity, such as school nutrition policies at school and state levels, policies that tax sugar-sweetened beverages, improvements in built and social environments in public housing, as well as park restoration and changes in public transit.
US Preventive Services Task Force Screening Guidelines and Cancer Intervention and Surveillance Network
DCCPS plans, implements, and maintains a comprehensive research program to promote the appropriate use of effective cancer screening tests, as well as strategies for informed decision-making regarding cancer screening technologies, in both community and clinical practice. For example, the US Preventive Services Task Force (USPSTF) has utilized results from the Cancer Intervention and Surveillance Modeling Network (CISNET), funded by DCCPS, to estimate the harms and benefits of many different screening regimens to help inform the task force as they develop screening recommendations for breast, colorectal, lung, and cervical cancers. The CISNET breast cancer group found that biennial strategies were most efficient for average-risk women, and for women with a two- to fourfold increased risk, annual screening starting at age 40 had similar harms and benefits as screening average-risk women biennially from age 50 to 74. Many of the breast cancer screening analyses were possible, in part, because of the contributions to current screening practices and outcomes by the DCCPS-funded Breast Cancer Surveillance Consortium (BCSC), a well-established research resource for studies designed to assess the delivery and quality of breast cancer screening. This large, standardized dataset presents a unique opportunity for investigators throughout the country to study how mammography screening performance may be improved and how breast cancer screening relates to changes in disease stage at diagnosis, survival, and mortality. In the past 15 years, BCSC data have had an impact on a wide range of scientific and policy arenas beyond the immediate work of the consortium.
For colorectal cancer, the simulation modeling helped to support recommendations that average-risk adults stop screening at age 75, that if a stool-based screening test is performed, a test with high sensitivity is used, and adding computed tomography colonography every 5 years as a screening strategy. In the most recent review of colorectal cancer screening recommendations, CISNET modeling helped to support the change in initiation age of screening from age 50 to 45. The CISNET colorectal group worked with AHRQ and CMS to produce an economic analysis that CMS used to initially inform coverage and the reimbursement level of the fecal immunochemical test (FIT).
The CISNET lung group considered hundreds of different strategies for lung cancer screening that differed by starting age, stopping age, periodicity, minimum pack years, and maximum number of years since quitting smoking. In a recent update of their prior recommendations, CISNET modeling helped inform the task force to lower the starting age for screening from age 55 to 50 and also a reduction in the minimum number of pack years from 30 to 20.
Modeling by the CISNET cervical group was influential in changing the recommendation from combined cytology and HPV testing every 5 years to high-risk HPV testing alone every 5 years in women age 30 to 65. In addition, the CISNET cervical group responded to the CDC’s Advisory Committees on Immunization Practices request for analyses to inform recommendations on mid-adult HPV vaccination.
For a fuller description and many more examples, please check out our report Informing Policy and Programs 2021, which will be published later this year.