Funding Cycle Research Articles

Transforming the Early Drug Development Paradigm at the National Cancer Institute: The Formation of NCI's Experimental Therapeutics Clinical Trials Network (ETCTN).

Early drug development for cancer requires broad collaboration and skilled clinical investigators to enable enrollment of patients whose tumors have defined molecular profiles. To respond to these challenges, the National Cancer Institute (NCI) transformed its 60-year-old early-phase drug development program in 2014 into the Experimental Therapeutics Clinical Trials Network (ETCTN). The ETCTN is a consolidated, national network of 40+ academic institutions responsible for conducting more than 100 early-phase clinical trials. It promotes team science coordinated among basic, translational, and clinical investigators, emphasizing the inclusion of early career trialists. This perspective provides a brief overview of the ETCTN, summarizes its successes and challenges over its first grant funding cycle, and discusses the program's future directions. Measures indicated strong connectivity across the institutions, significant increases in investigator approval of the ETCTN scientific portfolio from years 1 to 4, and substantial research activity over 5 years, with 334 letters of intent submitted, 102 trials activated, and 3,570 patients accrued. The ETCTN's successful adoption relied heavily on the inclusion of senior investigators who have long-standing interactions with the NCI and a willingness to participate in a team science approach and to mentor early career investigators. In addition, NCI invested substantial resources in a centralized infrastructure to conduct trials and to support the inclusion of biomarkers in its studies. The ETCTN provides evidence that a collaborative national clinical trial network for early drug development is feasible and can address the demands of precision medicine approaches to oncologic clinical trials.

Integrating the Family Wellbeing Program Into Practice: A Conceptual Model

ABSTRACT The experience of trauma in childhood can have lifelong consequences. For Indigenous people the effects can be overcome through protective factors such as connection to family and country, and feeling empowered by having more control over their lives in the socio-political environment in which they are living. There is growing evidence for trauma-informed social and emotional wellbeing (SEWB) interventions that foster a sense of empowerment and enable positive personal- and community-level outcomes. However, in the face of challenges such as short-term funding cycles, such programs are hard to sustainably implement and evaluate over time, even where they demonstrate promise. This article reflects on a successful experience of integrating the Family Wellbeing empowerment program into an existing child and family support organisation. It presents the essential elements for integrating a SEWB program as a conceptual model and highlights the implications for sustainable implementation of promising SEWB programs in new settings. IMPLICATIONS Integrating promising SEWB programs into the work practices of existing service organisations creates opportunities for longer term program sustainability and evaluation. Having Indigenous people leading the integration of SEWB programs has profound benefits in advancing knowledge and practice when working with Indigenous children and families. A conceptual model contributes to an area where more research and practice evidence is needed.

The National Project on Achievement in Twins.

The National Project on Achievement in Twins (NatPAT) began in 2017 as part of the third funding cycle of the Florida Learning Disabilities Research Center, a program project grant funded by the Eunice Kennedy Shriver National Institute of Child Health and Development. NatPAT will have a nationally representative sample of elementary school-aged twins in the United States. The overall goal of the project is to uncover salient factors, including genetic and environmental influences, which contribute to the co-development of reading and math performance during the critical developmental period of elementary school. Here we present the specific aims, methods and materials, and future directions of the project.

Promoting congregant health in faith-based organizations across Los Angeles County, 2013-2016.

The Los Angeles County Department of Public Health (DPH) launched the Nutrition Education and Obesity Prevention (NEOP) Project in fall 2013. As the local arm of the Supplemental Nutrition Assistance Program Education (SNAP-Ed), this project partnered with faith-based organizations (FBOs) in Los Angeles County to implement policy, systems, and environmental change interventions (PSEs) at selected church sites, alongside the usual delivery of health education.A 2-part programmatic assessment was conducted to better understand how the NEOP Faith Based Project at one of the FBOs was implemented during the 2013–2016 SNAP-Ed funding cycle. A qualitative component (key informant interviews) sought to understand and describe the PSE implementation process at each of the participating church sites, whereas the quantitative component (surveys) focused on assessing congregant perceptions about their awareness of the PSEs, their knowledge and beliefs about health, and their self-reported health behaviors after exposure to onsite changes.Among congregants who participated in the survey, 52% expressed desire for more health education classes. However, only 37% reported being aware of them at church sites that hosted them. When asked to compare their behaviors for “today” versus 6 months ago, more than half reported greater interest in eating more fruits and vegetables (66%), choosing water over soda (69%), and becoming more physically active (59%).Results from the NEOP Project have implications for how local health departments could partner with FBOs to outreach and promote health among congregants, particularly for those who are at high-risk of diet-related diseases due to poor nutrition and obesity.

Decadal plant composition changes in grazed native grassland

SummaryMost high value grasslands of south‐eastern Australia are restricted to small fragmented areas of public land. However, a significant proportion of native grassland is privately owned, managed with grazing rather than fire and is rarely monitored. Hence, a better understanding of grassland management and conservation on the private estate is required. Eco‐markets are policy instruments that incentivise private landholders to effectively manage and conserve native vegetation. However, short funding cycles restrict the capacity of monitoring programs to assess long‐term vegetation changes. In this study, 17 native grassland remnants on private land managed with livestock grazing were monitored before and during a 4‐year eco‐market and 6 years after it ended to determine how composition had changed over 10 years of monitoring. Numerous grassland attributes were either maintained or improved over the 10‐year period, which coincided with one of the most severe and long‐lasting droughts in recent history (i.e. the Millennium drought). In addition, several threatened species were identified as part of the program. A decline in exotic forb richness, native grass cover and native forb richness suggests there is also some impact of the Millennium drought on plant mortality as evidenced by altered litter dynamics. Inherent variability year‐to‐year for most measures of grassland attributes over the monitoring period indicates that climatic conditions have a strong influence on grassland dynamics. Our ability to determine the driver(s) of grassland composition was limited by monitoring program design. Future eco‐market monitoring programs should have adequate resources allocated to enable effective monitoring designs, that incorporate reference information and control sites, and should aim to be long‐term (i.e. >10 years). This will provide clearer insights into the drivers of grassland dynamics and allow for refinement of management options for conservation of this threatened community.

Supplemental Nutrition Assistance Program Education in Los Angeles County: Lessons and observations from the field, 2013-2016.

Although the California Department of Public Health has been delivering nutrition education for nearly two decades, the use of Supplemental Nutrition Assistance Program Education (SNAP-Ed) resources to advance policy, systems, and environmental change interventions (PSEs) to prevent obesity has been relatively recent. To date, most efforts to couple PSEs to conventional nutrition education have not been well-studied and as such, their lessons have not been used extensively in local planning. This special issue seeks to close this gap by sharing lessons from the planning and implementation of these efforts in Los Angeles County during the 2013–2016 SNAP-Ed funding cycle. It comprises a collection of six articles that recount key experiences from this work in the field.

Contextual assessment of the breadth and level of investments made by prevention initiatives to improve nutrition and prevent obesity in Los Angeles County, 2010-2015.

To better characterize and understand local investments made by prevention initiatives to address poor nutrition and obesity during 2010–2015, the Los Angeles County Department of Public Health partnered with an evaluation firm in 2014 to conduct a context scan of nutrition education programs (NEs) and policy, systems, and environmental change interventions (PSEs) in Los Angeles County (LAC). Using fiscal year 2012–2013 (FY12–13) as a midpoint for a before/after comparison based in part on the timeline of the last USDA Supplemental Nutrition Assistance Program Education (SNAP-Ed) funding cycle, the scan included both SNAP-Ed and non-SNAP-Ed initiatives.Systematic searches of peer-reviewed and grey literature, relevant organizations' websites and materials, and results from 51 key stakeholder interviews, were completed to help develop a context scan database for LAC.Thematic and content analyses of the context scan and interview data generated a “snapshot” of NE and PSE investments in the region. During the sampled period, at least $210 million was invested countywide to combat poor nutrition and obesity. Before FY12–13, 29 NEs and 33 PSEs were implemented. The PSEs included active transportation policies, healthy retail store conversions, and physical activity programming. NEs and PSEs increased to 50 and 98, respectively, after FY12–13.The context scan described the breadth and content of past and ongoing NEs and PSEs implemented by several prevention initiatives in LAC to improve nutrition and prevent obesity. Results suggest opportunities where SNAP-Ed can further tailor NE/PSE resources to address the needs of its target population.

Inclusive engagement for health and development or \u2018political theatre\u2019: results from case studies examining mechanisms for country ownership in Global Fund processes in Malawi, Tanzania and Zimbabwe

BackgroundFor many countries, including Malawi, Tanzania and Zimbabwe, 2017 was a transition year for support from the Global Fund to Fight AIDS, Tuberculosis and Malaria as one funding cycle closed and another would begin in 2018. Since its inception in 2001, the Global Fund has required that countries demonstrate ownership and transparency in the development of their funding requests through specific processes for inclusive, deliberative engagement led by Country Coordinating Mechanisms (CCMs). In reporting results from case study research, the article explores whether, in the context of the three countries, such requirements continue to be fit-for-purpose given difficult choices to be made for financing and sustaining their HIV programmes.ResultsThe findings show how complex, competing priorities for limited resources increasingly strain processes for inclusive deliberation, a core feature of the Global Fund model. Each country has chosen expansion of HIV treatment programmes as its main strategy for epidemic control relying almost exclusively on external funding sources for support. This step has, in effect, pre-committed HIV funding, whether available or not, well into the future. It has also largely pre-empted the results of inclusive dialogue on how to allocate Global Fund resources. As a result, such processes may be entering the realm of ‘political theatre,’ or processes for processes’ sake alone, rather than being important opportunities where critical decisions regarding priorities for national HIV programmes and how they are funded could or should be made.ConclusionTo address this, the Global Fund has begun an initiative to shore-up the capabilities of CCMs, with specialised technical and financial support, so that they can both grasp and influence the overall financing and sustainability of HIV programmes, rather than focussing on Global Fund programmes alone. What stronger CCMs could achieve, given the growing HIV-treatment-related commitments in these three countries, remains to be seen. Starting in 2020, the three countries will discover what resources the Global Fund will have for them for the 2021–2023 period. The resource needs for expanding HIV treatment programmes for this period are already foreseeable leaving few if any options for future deliberation should funding from the Global Fund and others not grow at a similar pace.

Lost Floodplain Wetland Environments and Efforts to Restore Connectivity, Habitat, and Water Quality Settings on the Great Barrier Reef

Managers are moving towards implementing large-scale coastal ecosystem restoration projects, however, many fail to achieve desired outcomes. Among the key reasons for this are a lack of integration with a whole-of-catchment approach, the scale of the project (temporal, spatial), the requirement for on-going costs for maintenance, lack of clear objectives, a focus on threats rather than services/values, funding cycles, engagement or change in stakeholders, and prioritization of project sites. Here we critically assess the outcomes of activities in three coastal wetland complexes positioned along the catchments of the Great Barrier Reef (GBR) lagoon, Australia, that have been subjected to restoration investment over a number of decades. Each floodplain has been modified by intensive agricultural production, heavy industry and mining infrastructure, urban/peri urban expansion, aquaculture development and infrastructure expansion. Most development has occurred in low-lying coastal floodplains, resulting in major hydrological modifications to the landscape. This has left the floodplain wetlands in a degraded and hydrologically modified state, with poor water quality (hypoxic, eutrophication, sedimentation, and persistent turbidity), loss of habitat, and disconnected because of flow hydraulic barriers, excessive aquatic plant growth, or establishment of invasive species. Successful GBR wetland ecosystem restoration and management must first include an understanding of what constitutes ‘success' and be underpinned by understanding of complex cause and effect pathways, with a focus on management of services and values. This approach should recognize these wetlands are still assets in a modified landscape. Suitable, long term, scientific knowledge is necessary to provide government and private companies with the confidence and comfort that their investment delivers dividend (environmental) returns.

Understanding innovation in health program planning and development

IntroductionA need for innovative public health programs is evident as the field adapts to address changes in health priorities and target populations. The Innovative Teen Pregnancy Prevention Program (iTP3) was created to support and enable innovation in teenage pregnancy prevention, developing programs to reach the most at risk youth. MethodsA formative evaluation was conducted to understand what innovation means in the context of program development, and examine the process of innovation. Qualitative data was collected through baseline interviews with program development teams, referred to as Innovators, prior to the start of the project period and follow-up interviews conducted at the end of a 12-month funding period. Additional open-ended written responses were collected in the middle of the funding cycle. A thematic analysis with an open-coding scheme was used to identify emergent themes. ResultsInnovators considered programs innovative because of the target population of focus, program delivery mechanism, and/or program development approach. They specifically identified that a “culture” of innovation must be present if new programs are to be developed. Over time, Innovators began to shift their definition of innovation toward unique design processes and ecological approaches. DiscussionThrough creating a culture of innovation and utilizing systems thinking, this project provides important insights in how to develop innovations in public health.

Back to Bedside: Defining Success.

Back to Bedside: Defining Success.

How long is a dingo's tale?: Impacts of sampling design on our understanding of dingo ecology

ABSTRACT The temporal scale of many studies of dingo ecology is limited by human and physical resources, often constrained by funding cycles. Consequently, research has been skewed towards short-term, snapshot investigations undertaken at a spatial scale that is unrelated to dingo home range size, space use and life history. In turn, the certainty of ecological conclusions is constrained. Here we discuss the difficulties and limitations of much of the dingo research previously undertaken, including our own, and discuss the benefits of long-term data sets for elucidating ecological processes involving dingoes. We provide explanatory examples where current technological advances provide opportunities for improved monitoring and certainty around conclusions.

Knowledge mobilisation for chronic disease prevention: the case of the Australian Prevention Partnership Centre

BackgroundCross-sectoral, multidisciplinary partnership research is considered one of the most effective means of facilitating research-informed policy and practice, particularly for addressing complex problems such as chronic disease. Successful research partnerships tend to be underpinned by a range of features that enable knowledge mobilisation (KMb), seeking to connect academic researchers with decision-makers and practitioners to improve the nature, quality and use of research. This paper contributes to the growing discourse on partnership approaches by illustrating how knowledge mobilisation strategies are operationalised within the Australian Prevention Partnership Centre (the Centre), a national collaboration of academics, policy-makers and practitioners established to develop systems approaches for the prevention of lifestyle-related chronic diseases.MethodsWe undertook interviews with key academics, policy, and practice partners and funding representatives at the mid-point of the Centre’s initial 5-year funding cycle. We aimed to explore how the Centre is functioning in practice, to develop a conceptual model of KMb within the Centre for use in further evaluation, and to identify ways of strengthening our approach to partnership research. Inductive and deductive thematic analysis was used to identify the key mechanisms underpinning the Centre’s KMb approach.ResultsSix key mechanisms appeared to facilitate KMb within our Centre, namely Engagement, Partnerships, Co-production, Capacity and Skills, Knowledge Integration, and Adaptive Learning and Improvement. We developed a conceptual model that articulated these mechanisms in relation to the structures and processes that support them, as well as the Centre’s goals. Findings also informed adaptations designed to strengthen the Centre.ConclusionsFindings provide insights into the practical realities of operationalising KMb strategies within a research partnership. Overall, the centre is perceived to be progressing towards its KMb goals, but challenges include stakeholders from different settings understanding each other’s contexts and working together effectively, and ensuring knowledge generated across different projects within the Centre is integrated into a more comprehensive understanding of chronic disease prevention policy and practice. Our conceptual model is now informing ongoing developmental evaluation activities within the Centre, where it is being tested and refined.

Trust Central Eases Funding Decisions With Data

The Children’s Trust is a local government taxing authority that uses property tax dollars to fund programming for Miami-Dade County children and families. To become more efficient, Trust Central was created and now automates our full business cycle. Data flow is solicitation → contracting → program metrics → solicitation. Agencies apply for funding, contract to provide services, report their progress. Their progress is used to determine future solicitation criteria. Data automatically flows from one module to another.
 Trust Central allowed us to move from using 5 data points to make funding decisions to 24 data points. We were able to look across our various initiatives to ensure that our funding decisions were equitable. Funding decisions were backed by data and easy to share with applicants. We created context and communicated funding decisions in a way that reduced emotional conflicts and appeals. As a reference point, we had 96 appeal meetings last funding cycle - this funding cycle no appeal meetings and only 19 review meetings; a cost savings of $15,850 in meetings. Another reference point, we spent 1 week reviewing data to make funding decisions last funding cycle - this funding cycle we spent 4 weeks reviewing data in a more meaningful and valuable way. We made $68M in funding decisions without any negative feedback from the community. Our relationship with the community pivoted from negative to positive. This is a first for us! We are now positioned to be a mentor for both governmental and non-governmental funders.

Financier Search and Boundaries of the Angel and VC Markets

This paper studies how critical entrepreneurial finance outcomes such as the investment return and equity division are shaped by venture characteristics, financier risk preferences, and competitive searching. Our analysis uses a double-hazard agency model in which financiers determine the equity division to maximize the expected utility of their investment return while entrepreneurs search for the best deal. Model results provide new theoretical insights on the venture funding cycle, the coexistence of angels/venture capitalists (VCs) with heterogeneous risk aversion, and risk separation in the entrepreneurial finance market. The model predicts that financiers with higher funding capacity and advisory capabilities (e.g., VC firms) will prefer to fund at later stages as their expected investment return rises with the venture’s initial value and financier productivity. Competitive searching by entrepreneurs enables financiers with a diverse set of risk preferences to coexist profitably by reducing the advantage (disadvantage) of lower (higher) risk aversion financiers and making investment returns more similar. Further, the model shows the emergence of a risk separation cutoff beyond which only angels/VCs with lower levels of risk aversion can profitably fund riskier ventures.

The Clinical Sequencing Evidence-Generating Research Consortium: Integrating Genomic Sequencing in Diverse and Medically Underserved Populations

The Clinical Sequencing Evidence-Generating Research (CSER) consortium, now in its second funding cycle, is investigating the effectiveness of integrating genomic (exome or genome) sequencing into the clinical care of diverse and medically underserved individuals in a variety of healthcare settings and disease states. The consortium comprises a coordinating center, six funded extramural clinical projects, and an ongoing National Human Genome Research Institute (NHGRI) intramural project. Collectively, these projects aim to enroll and sequence over 6,100 participants in four years. At least 60% of participants will be of non-European ancestry or from underserved settings, with the goal of diversifying the populations that are providing an evidence base for genomic medicine. Five of the six clinical projects are enrolling pediatric patients with various phenotypes. One of these five projects is also enrolling couples whose fetus has a structural anomaly, and the sixth project is enrolling adults at risk for hereditary cancer. The ongoing NHGRI intramural project has enrolled primarily healthy adults. Goals of the consortium include assessing the clinical utility of genomic sequencing, exploring medical follow up and cascade testing of relatives, and evaluating patient-provider-laboratory level interactions that influence the use of this technology. The findings from the CSER consortium will offer patients, healthcare systems, and policymakers a clearer understanding of the opportunities and challenges of providing genomic medicine in diverse populations and settings, and contribute evidence toward developing best practices for the delivery of clinically useful and cost-effective genomic sequencing in diverse healthcare settings.

From Principles to Practice: Real-World Patient and Stakeholder Engagement in Breast Cancer Research.

The Patient-Centered Outcomes Research Institute (PCORI) in Washington, DC, has catalyzed a meaningful shift in the composition of research project teams since its initial research funding cycle in 2011. Despite the influx of funding in the research community for patient-centered research, research on how to effectively engage patients and stakeholders in the research process is still relatively nascent. Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, WA, was an early recipient of PCORI research funding and, as of December 2017, has received 8 PCORI research awards totaling nearly $15 million. Anticipating the pivotal importance of PCORI's patient-focused approach, KPWHRI developed a set of 8 principles to guide how research teams should work with patients and other stakeholders to simultaneously achieve research aims and embrace this new paradigm in how research teams collaborate. With a goal of assisting other research teams, this article describes the genesis of the KPWHRI principles, their relevance to patient- and stakeholder-engaged research, and how these principles were brought to life in the context of a specific PCORI-funded project on surveillance imaging in women after a breast cancer diagnosis.

Cohesion Policy incentives for collaborative industrial research: evaluation of a Smart Specialisation forerunner programme

ABSTRACT This paper evaluates a programme of subsidies for collaborative industrial research (co-)funded by the European Union’s Cohesion Policy in Italy mobilizing over €1 billion. In the 2007–13 funding cycle, the programme was a precursor to some of the key features of Smart Specialisation Strategy (S3) programmes, offering evidence-based insights into potential challenges of the practical application of the S3 approach. The programme was unsuccessful in boosting investments, value added or employment of beneficiary firms. The collaborative dimension of the projects added limited value and a more generous funding level would not have improved effectiveness. However, positive impacts emerged in low-tech sectors.

Interdisciplinary and transdisciplinary research: finding the common ground of multi-faceted concepts

Inter- and transdisciplinarity are increasingly relevant concepts and research practices within academia. Although there is a consensus about the need to apply these practices, there is no agreement over definitions. Building on the outcomes of the first year of the COST Action TD1408 “Interdisciplinarity in research programming and funding cycles” (INTREPID), this paper describes the similarities and differences between interpretations of inter- and transdisciplinarity. Drawing on literature review and empirical results from participatory workshops involving INTREPID Network members from 27 different countries, the paper shows that diverse definitions of inter-and transdisciplinarity coexist within scientific literature and are reproduced by researchers and practitioners within the network. The recognition of this diversity did not hinder the definition of basic requirements for inter- and transdisciplinarity. We present five basic units considered as building blocks for this type of research. These building blocks are: (1) creation of collective glossaries, (2) definition of boundary objects, (3) use of combined problem- and solution-oriented approaches, (4) inclusion of a facilitator of inter-and transdisciplinary research within the team and (5) promotion of reflexivity by accompanying research. These were considered five basic units for effective inter- and transdisciplinary research although the 4th building block was also considered as “matrix” that holds all the others together.

Researchers, Patients, and Stakeholders Evaluating Comparative-Effectiveness Research: A Mixed-Methods Study of the PCORI Reviewer Experience

ObjectivesThe Patient-Centered Outcomes Research Institute (PCORI) includes patients and stakeholders alongside scientists in reviewing research applications using unique review criteria including patient-centeredness and patient and/or stakeholder engagement. To support extension of this unique collaborative model to other funders, information from the reviewers on the review process is needed to understand how scientists and nonscientists evaluate research proposals together. Thus, this study aimed to describe reviewers’ perspectives of the interactions during the in-person review panel; to examine the value and challenges of including scientists, patients, and stakeholders together; and to understand the perceived importance of PCORI’s review criteria. MethodsThis study utilized anonymous, cross-sectional surveys (N = 925 respondents from 5 funding cycles: 470 scientists, 217 patients, 238 stakeholders; survey completion rates by cycle: 70–89%) and group interviews (N = 18). ResultsReviewers of all types describe PCORI Merit Review as respectful, balanced, and one of reciprocal influence among different reviewer types. Reviewers indicate strong support and value of input from all reviewer types, receptivity to input from others, and the panel chair’s incorporation of all views. Patients and stakeholders provide real-world perspectives on importance to patients, research partnership plans, and study feasibility. Challenges included concerns about a lack of technical expertise of patient/stakeholder reviewers and about scientists dominating conversations. The most important criterion for assigning final review scores was technical merit—either alone or in conjunction with patient-centeredness or patient/ stakeholder engagement. ConclusionsPCORI Merit Reviewers’ self-reports indicate that the perspectives of different reviewer types are influential in panel discussions and Merit Review outcomes.