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ROADMAP is a public-private advisory partnership to evaluate the usability of multiple data sources, including real-world evidence, in the decision-making process for new treatments in Alzheimer's disease, and to advance key concepts in disease and pharmacoeconomic modeling. ROADMAP identified key disease and patient outcomes for stakeholders to make informed funding and treatment decisions, provided advice on data integration methods and standards, and developed conceptual cost-effectiveness and disease models designed in part to assess whether early treatment provides long-term benefit.
Pubmed ID: 30584137
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Consortium that aims to improve the efficiency of the medicine development process by better incorporating estimates of relative effectiveness into drug development and to enrich decision-making by regulatory authorities and health technology assessment (HTA) bodies through: * Bringing together regulators, HTA bodies, academics, companies, patients and other societal stakeholders; * Assessing existing processes, methodologies, and key research issues; * Proposing innovative (and more pragmatic) trial designs and assessing the value of information; * Proposing and testing innovative analytical and predictive modelling approaches; * Assessing operational, ethical, regulatory issues and proposing and testing solutions; * Creating new decision making frameworks, and building open tools to allow for the evaluation of development programs and use in the assessment of the value of new medicines; * Sharing and discussing deliverables with, among others, Pharmaceutical companies, regulatory authorities, HTA / reimbursement agencies, clinicians and patient organizations; * Developing training activities for researchers, decision makers and societal stakeholders in the public and private sector in order to increase knowledge about various aspects of relative effectiveness. The expected impact is that it will contribute to the knowledge base, particularly to inform clinical decision making and improve the efficiency of the R&D process. GETREAL will help to generate a consensus on best practice in the timing, performance and use of real life clinical studies in regulatory and reimbursement decision-making. It will also help to create a strong platform for the communication of results and for future discussions in this important area.
View all literature mentionstranSMART is a knowledge management platform that enables scientists to develop and refine research hypotheses by investigating correlations between genetic and phenotypic data, and assessing their analytical results in the context of published literature and other work. tranSMART is licensed through GPL 3. The integration, normalization, and alignment of data in tranSMART permits users to explore data very efficiently to formulate new research strategies. Some of tranSMART''s specific applications include: * Revalidating previous hypotheses * Testing and refining novel hypotheses * Conducting cross-study meta-analysis * Searching across multiple data sources to find associations of concepts, such as a gene''s involvement in biological processes or experimental results * Comparing biological processes and pathways among multiple data sets from related diseases or even across multiple therapeutic areas Data Repository The tranSMART Data Repository combines a data warehouse with access to federated sources of open and commercial databases. tranSMART accommodates: * Phenotypic data, such as demographics, clinical observations, clinical trial outcomes, and adverse events * High content biomarker data, such as gene expression, genotyping, pharmacokinetic and pharmaco-dynamics markers, metabolomics data, and proteomics data * Unstructured text-data, such as published journal articles, conference abstracts and proceedings, and internal studies and white papers * Reference data from sources such as MeSH, UMLS, Entrez, GeneGo, Ingenuity, etc. * Metadata providing context about datasets, allowing users to assess the relevance of results delivered by tranSMART Data in tranSMART is aligned to allow identification and analysis of associations between phenotypic and biomarker data, and it is normalized to conform with CDISC and other standards to facilitate search and analysis across different data sources. tranSMART also enables investigators to search published literature and other text sources to evaluate their analysis in the context of the broader universe of reported research. External data can also be integrated into the tranSMART data repository, either from open data projects like GEO, EBI Array Express, GCOD, or GO, or from commercially available data sources. Making data accessible in tranSMART enables organizations to leverage investments in manual curation, development costs of automated ETL tools, or commercial subscription fees across multiple research groups. Dataset Explorer tranSMART''s Dataset Explorer provides flexible, powerful search and analysis capabilities. The core of the Dataset Explorer integrates and extends the open source i2b2 application, Lucene text indexing, and GenePattern analytical tools. Connections to other open source and commercial analytical tools such as Galaxy, Integrative Genomics Viewer, Plink, Pathway Studio, GeneGo, Spotfire, R, and SAS can be established to expand tranSMART''s capabilities. tranSMART''s design allows organizations flexibility in selecting analytical tools accessible through the Dataset Explorer, and provides file export capabilities to enable researchers to use tools not accessible in the tranSMART portal.
View all literature mentionsA project that aims to improve access to human health data by developing a common information framework (EMIF-Platform) that allows for efficient re-use of existing health data, opening up new avenues of research for scientists. To ensure immediate applicability, the project includes two specific therapeutic research topics: the onset of Alzheimer's Disease (EMIF-AD) and metabolic complications of obesity (EMIF-Metabolics). The AD Topic aims to discover and validate biomarkers of AD onset in the preclinical and prodromal phase as well as for disease progression and identify high-risk individuals for therapeutic trials for prevention. The Metabolic Topic aims to discover and evaluate biomarkers for the risk of metabolic complications in obesity and to identify high-risk populations for intervention purposes. Collaboration between the 3 topics will ensure the development and delivery of an efficient Information Framework. This initiative has combined several data sets for neuroimaging including ADNI and several others, curating them into transmart.
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