Advancing a Vision for Regulatory Science Training.
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ABSTRACT:
SUBMITTER: Adamo JE
PROVIDER: S-EPMC5351091 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Biology research is becoming increasingly dependent on large-scale, "big data," networked research initiatives. At the same time, there has been a corresponding effort to expand undergraduate participation in research to benefit student learning and persistence in science. This essay examines the confluence of this trend through eight years of a collaboration within a successful biology research network that explicitly incorporates undergraduates into large-scale scientific research. We draw upon interviews with faculty in this network to consider the interplay of scientific and pedagogical objectives at the heart of this undergraduate-focused network research project. We identify ways that this network has expanded and diversified access to scientific knowledge production for faculty and students and examine a goal conflict that emerged around the dual objectives of mentoring emerging scientists while producing high-quality scientific data for the larger biology community. Based on lessons learned within this network, we provide three recommendations that can support institutions and faculty engaging in networked research projects with undergraduates: (1) establish rigorous protocols to ensure data and database quality, (2) protect personnel time to coordinate network and scientific processes, and (3) select appropriate partners and establish explicit expectations for specific collaborations.
| S-EPMC8693944 | biostudies-literature
Project description:Protecting and promoting public health is the mission of the U.S. Food and Drug Administration (FDA). FDA's Center for Devices and Radiological Health (CDRH), which regulates medical devices marketed in the U.S., envisions itself as the world's leader in medical device innovation and regulatory science-the development of new methods, standards, and approaches to assess the safety, efficacy, quality, and performance of medical devices. Traditionally, bench testing, animal studies, and clinical trials have been the main sources of evidence for getting medical devices on the market in the U.S. In recent years, however, computational modeling has become an increasingly powerful tool for evaluating medical devices, complementing bench, animal and clinical methods. Moreover, computational modeling methods are increasingly being used within software platforms, serving as clinical decision support tools, and are being embedded in medical devices. Because of its reach and huge potential, computational modeling has been identified as a priority by CDRH, and indeed by FDA's leadership. Therefore, the Office of Science and Engineering Laboratories (OSEL)-the research arm of CDRH-has committed significant resources to transforming computational modeling from a valuable scientific tool to a valuable regulatory tool, and developing mechanisms to rely more on digital evidence in place of other evidence. This article introduces the role of computational modeling for medical devices, describes OSEL's ongoing research, and overviews how evidence from computational modeling (i.e., digital evidence) has been used in regulatory submissions by industry to CDRH in recent years. It concludes by discussing the potential future role for computational modeling and digital evidence in medical devices.
| S-EPMC6167449 | biostudies-other
Project description:BackgroundThe UK's transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science.MethodsA survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied.ResultsPriority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for "pay for performance" products; and education and professional development.ConclusionsThe UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients' experiences and perspectives, and investing in a skilled workforce.
| S-EPMC7885762 | biostudies-literature
Project description:The way in which we assess researchers has been under the radar in the past few years. Critics argue that current research assessments focus on productivity and that they increase unhealthy pressures on scientists. Yet, the precise ways in which assessments should change is still open for debate. We circulated a survey with Flemish researchers to understand how they work, and how they would rate the relevance of specific indicators used in research assessments. We found that most researchers worked far beyond their expected working schedule. We also found that, although they spent most of their time doing research, respondents wished they could dedicate more time to it and spend less time writing grants and performing other activities such as administrative duties and meetings. When looking at success indicators, we found that indicators related to openness, transparency, quality, and innovation were perceived as highly important in advancing science, but as relatively overlooked in career advancement. Conversely, indicators which denoted of prestige and competition were generally rated as important to career advancement, but irrelevant or even detrimental in advancing science. Open comments from respondents further revealed that, although indicators which indicate openness, transparency, and quality (e.g., publishing open access, publishing negative findings, sharing data, etc.) should ultimately be valued more in research assessments, the resources and support currently in place were insufficient to allow researchers to endorse such practices. In other words, current research assessments are inadequate and ignore practices which are essential in contributing to the advancement of science. Yet, before we change the way in which researchers are being assessed, supporting infrastructures must be put in place to ensure that researchers are able to commit to the activities that may benefit the advancement of science.
| S-EPMC7878066 | biostudies-literature
Project description:PurposeFood and Drug Administration's (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge-attitudes-behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies.MethodsA systematic literature review was conducted of US physician surveys (2000-2014) on pharmaceutical use (n = 75). Kruskal-Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson's chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks).ResultsSurvey response rates ranged from 7% to 100% (median = 48%, IQR = 34%-68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items).ConclusionsPublished data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias.
| S-EPMC6799639 | biostudies-literature
Project description:BackgroundDecision analysis-a systematic approach to solving complex problems-offers tools and frameworks to support decision making that are increasingly being applied to environmental challenges. Alternatives analysis is a method used in regulation and product design to identify, compare, and evaluate the safety and viability of potential substitutes for hazardous chemicals.ObjectivesWe assessed whether decision science may assist the alternatives analysis decision maker in comparing alternatives across a range of metrics.MethodsA workshop was convened that included representatives from government, academia, business, and civil society and included experts in toxicology, decision science, alternatives assessment, engineering, and law and policy. Participants were divided into two groups and were prompted with targeted questions. Throughout the workshop, the groups periodically came together in plenary sessions to reflect on other groups' findings.ResultsWe concluded that the further incorporation of decision science into alternatives analysis would advance the ability of companies and regulators to select alternatives to harmful ingredients and would also advance the science of decision analysis.ConclusionsWe advance four recommendations: a) engaging the systematic development and evaluation of decision approaches and tools; b) using case studies to advance the integration of decision analysis into alternatives analysis; c) supporting transdisciplinary research; and d) supporting education and outreach efforts. https://doi.org/10.1289/EHP483.
| S-EPMC5743447 | biostudies-literature
Project description:In the past few decades, prevention scientists have developed and tested a range of interventions with demonstrated benefits on child and adolescent cognitive, affective, and behavioral health. These evidence-based interventions offer promise of population-level benefit if accompanied by findings of implementation science to facilitate adoption, widespread implementation, and sustainment. Though there have been notable examples of successful efforts to scale up interventions, more work is needed to optimize benefit. Although the traditional pathway from intervention development and testing to implementation has served the research community well-allowing for a systematic advance of evidence-based interventions that appear ready for implementation-progress has been limited by maintaining the hypothesis that evidence generation must be complete prior to implementation. This sets up the challenging dichotomy between fidelity and adaptation and limits the science of adaptation to findings from randomized trials of adapted interventions. The field can do better. This paper argues for the development of strategies to advance the science of adaptation in the context of implementation that would more comprehensively describe the needed fit between interventions and their settings, and embrace opportunities for ongoing learning about optimal intervention delivery over time. Efforts to build the resulting adaptome (pronounced "adapt-ohm") will include the construction of a common data platform to house systematically captured information about variations in delivery of evidence-based interventions across multiple populations and contexts, and provide feedback to intervention developers, as well as the implementation research and practice communities. Finally, the article identifies next steps to jumpstart adaptome data platform development.
| S-EPMC5030159 | biostudies-other
Project description:Pathologies affecting central vision, and macular degeneration (MD) in particular, represent a growing health concern worldwide, and the leading cause of blindness in the Western World. To cope with the loss of central vision, MD patients often develop compensatory strategies, such as the adoption of a Preferred Retinal Locus (PRL), which they use as a substitute fovea. However, visual acuity and fixation stability in the visual periphery are poorer, leaving many MD patients struggling with tasks such as reading and recognizing faces. Current non-invasive rehabilitative interventions are usually of two types: oculomotor, aiming at training eye movements or teaching patients to use or develop a PRL, or perceptual, with the goal of improving visual abilities in the PRL. These training protocols are usually tested over a series of outcome assessments mainly measuring low-level visual abilities (visual acuity, contrast sensitivity) and reading. However, extant approaches lead to mixed success, and in general have exhibited large individual differences. Recent breakthroughs in vision science have shown that loss of central vision affects not only low-level visual abilities and oculomotor mechanisms, but also higher-level attentional and cognitive processes. We suggest that effective interventions for rehabilitation after central vision loss should then not only integrate low-level vision and oculomotor training, but also take into account higher level attentional and cognitive mechanisms.
| S-EPMC8599964 | biostudies-literature
Project description:BackgroundPrecision health considers individual lifestyle, genetics, behaviors, and environment context and facilitates interventions aimed at helping individuals achieve well-being and optimal health.PurposeTo present the Nursing Science Precision Health (NSPH) Model and describe the integration of precision health concepts within the domains of symptom and self-management science as reflected in the National Institute of Nursing Research P30 Centers of Excellence and P20 Exploratory Centers.MethodsCenter members developed the NSPH Model and the manuscript based on presentations and discussions at the annual NINR Center Directors Meeting and in follow-up telephone meetings.DiscussionThe NSPH Model comprises four precision components (measurement; characterization of phenotype including lifestyle and environment; characterization of genotype and other biomarkers; and intervention target discovery, design, and delivery) that are underpinned by an information and data science infrastructure.ConclusionNurse scientist leadership is necessary to realize the vision of precision health as reflected in the NSPH Model.
| S-EPMC6688754 | biostudies-literature
Project description:Awareness of the human health impacts of exposure to air pollution is growing rapidly. For example, it has become evident that the adverse health effects of air pollution are more pronounced in disadvantaged populations. Policymakers in many jurisdictions have responded to this evidence by enacting initiatives that lead to lower concentrations of air pollutants, such as urban traffic restrictions. In this review, we focus on the interplay between advances in environmental exposure assessment and developments in policy. We highlight recent progress in the granular measurement of air pollutants and individual-level exposures, and how this has enabled focused local policy actions. Finally, we detail an illustrative study designed to link individual-level health-relevant exposures with economic, behavioral, biological, familial, and environmental variables.
| S-EPMC6420629 | biostudies-literature