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White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.

ABSTRACT: Pharmaceutical sciences experts and regulators acknowledge that pharmaceutical development as well as drug usage requires more than scientific advancements to cope with current attrition rates/therapeutic failures. Drug disease modeling and simulation (DDM&S) creates a paradigm to enable an integrated and higher-level understanding of drugs, (diseased)systems, and their interactions (systems pharmacology) through mathematical/statistical models (pharmacometrics)(1)-hence facilitating decision making during drug development and therapeutic usage of medicines. To identify gaps and challenges in DDM&S, an inventory of skills and competencies currently available in academia, industry, and clinical practice was obtained through survey. The survey outcomes revealed benefits, weaknesses, and hurdles for the implementation of DDM&S. In addition, the survey indicated that no consensus exists about the knowledge, skills, and attributes required to perform DDM&S activities effectively. Hence, a landscape of technical and conceptual requirements for DDM&S was identified and serves as a basis for developing a framework of competencies to guide future education and training in DDM&S.CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e40; doi:10.1038/psp.2013.16; advance online publication 1 May 2013.

SUBMITTER: Vlasakakis G

PROVIDER: S-EPMC3674326 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.

Vlasakakis G G Comets E E Keunecke A A Gueorguieva I I Magni P P Terranova N N Della Pasqua O O de Lange E C EC Kloft C C

CPT: pharmacometrics & systems pharmacology 20130501

Pharmaceutical sciences experts and regulators acknowledge that pharmaceutical development as well as drug usage requires more than scientific advancements to cope with current attrition rates/therapeutic failures. Drug disease modeling and simulation (DDM&S) creates a paradigm to enable an integrated and higher-level understanding of drugs, (diseased)systems, and their interactions (systems pharmacology) through mathematical/statistical models (pharmacometrics)(1)-hence facilitating decision ma ...[more]

PMID: 23887723

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Project description:BACKGROUND:Prognostic research has many important purposes, including (i) describing the natural history and clinical course of health conditions, (ii) investigating variables associated with health outcomes of interest, (iii) estimating an individual's probability of developing different outcomes, (iv) investigating the clinical application of prediction models, and (v) investigating determinants of recovery that can inform the development of interventions to improve patient outcomes. But much prognostic research has been poorly conducted and interpreted, indicating that a number of conceptual areas are often misunderstood. Recent initiatives to improve this include the Prognosis Research Strategy (PROGRESS) and the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) Statement. In this paper, we aim to show how different categories of prognostic research relate to each other, to differentiate exploratory and confirmatory studies, discuss moderators and mediators, and to show how important it is to understand study designs and the differences between prediction and causation. MAIN TEXT:We propose that there are four main objectives of prognostic studies - description, association, prediction and causation. By causation, we mean the effect of prediction and decision rules on outcomes as determined by intervention studies and the investigation of whether a prognostic factor is a determinant of outcome (on the causal pathway). These either fall under the umbrella of exploratory (description, association, and prediction model development) or confirmatory (prediction model external validation and investigation of causation). Including considerations of causation within a prognostic framework provides a more comprehensive roadmap of how different types of studies conceptually relate to each other, and better clarity about appropriate model performance measures and the inferences that can be drawn from different types of prognostic studies. We also propose definitions of 'candidate prognostic factors', 'prognostic factors', 'prognostic determinants (causal)' and 'prognostic markers (non-causal)'. Furthermore, we address common conceptual misunderstandings related to study design, analysis, and interpretation of multivariable models from the perspectives of association, prediction and causation. CONCLUSION:This paper uses a framework to clarify some concepts in prognostic research that remain poorly understood and implemented, to stimulate discussion about how prognostic studies can be strengthened and appropriately interpreted.

Project description:Over the past century, the environment of the Gulf of Mexico has been significantly altered and impaired by extensive human activities. A national commitment to restore the Gulf was finally initiated in response to the unprecedented Deepwater Horizon oil spill in 2010. Consequently, there is a critical need for an assessment framework and associated set of indicators that can characterize the health and sustainability of an ecosystem having the scale and complexity of the Gulf. The assessment framework presented here was developed as an integration of previous ecological risk- and environmental management-based frameworks for assessing ecosystem health. It was designed to identify the natural and anthropogenic drivers, pressures, and stressors impinging on ecosystems and ecosystem services, and the ecological conditions that result, manifested as effects on valued ecosystem components. Four types of societal and ecological responses are identified: reduction of pressures and stressors, remediation of existing stressors, active ecosystem restoration, and natural ecological recovery. From this conceptual framework are derived the specific indicators to characterize ecological condition and progress toward achieving defined ecological health and sustainability goals. Additionally, the framework incorporates a hierarchical structure to communicate results to a diversity of audiences, from research scientists to environmental managers and decision makers, with the level of detail or aggregation appropriate for each targeted audience. Two proof-of-concept studies were conducted to test this integrated assessment and decision framework, a prototype Texas Coastal Ecosystems Report Card, and a pilot study on enhancing rookery islands in the Mission-Aransas Reserve, Texas, USA. This Drivers-Pressures-Stressors-Condition-Responses (DPSCR4 ) conceptual framework is a comprehensive conceptual model of the coupled human-ecological system. Much like its predecessor, the ecological risk assessment framework, the DPSCR4 conceptual framework can be tailored to different scales of complexity, different ecosystem types with different stress regimes, and different environmental settings. Integr Environ Assess Manag 2019;15:544-564. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

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White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.

Publications

White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simulation.

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