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http://clinicalinformatics.stanford.edu/projects/cdw.html

Research and development project at Stanford University to create a standards-based informatics platform supporting clinical and translational research. STRIDE consists of three integrated components: a clinical data warehouse, based on the HL7 Reference Information Model (RIM), containing clinical information on over 1.6 million pediatric and adult patients cared for at Stanford University Medical Center since 1995; an application development framework for building research data management applications on the STRIDE platform and a biospecimen data management system. STRIDE's semantic model uses standardized terminologies, such as SNOMED, RxNorm, ICD and CPT, to represent important biomedical concepts and their relationships. STRIDE receives clinical data for research use via HL7 feeds from both SUMC hospitals: Lucile Packard Children's Hospital and Stanford Hospital and Clinics. This clinical data is used to support a wide variety of translational research services including: * Anonymized Patient Research Cohort Discovery * Electronic Chart Review for Research * IRB-Approved Clinical Data Extraction * Biospecimen Data Management * Multimedia Research * Data Management and Research Registries STRIDE is a highly secure environment utilizing encryption, fine-grained access control, robust auditing and detailed data segregation. Additionally, STRIDE has a robust access control framework with well-defined access granting authorities and access control groups. Consequently STRIDE meets or exceeds the requirements of the HIPAA Privacy and Security regulations. Privacy protection is further enhanced by requiring IRB approval for all research projects using STRIDE clinical data. From a technology and standards perspective, STRIDE is hosted on the Oracle 11g database platform. STRIDE application software provides access to the web services of a three-tier infrastructures using SSL encryption with strong authentication. These programs are cross-platform, self-updating thick-client applications that provides a rich user interface for data entry, retrieval and review as well as image manipulation and annotation. STRIDE makes extensive use of XML technologies for representation of structured meta data, distributed systems technologies using JSON for secure remote communication between client and server, and Swing graphical interface components providing a rich widget-set as well as advanced imaging and graphing capabilities. Users of the STRIDE Research Desktop Client can perform rapid data entry into structured fields, compose complex queries, and interact securely with clinical, research and imaging data.

Proper citation: Stanford Translational Research Integrated Database Environment and Clinical Data Warehouse (RRID:SCR_003453) Copy   

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http://www.nih.gov/science/amp/alzheimers.htm

The Alzheimer's disease arm of the Accelerating Medicines Partnership (AMP) that will identify biomarkers that can predict clinical outcomes, conduct a large scale analysis of human AD patient brain tissue samples to validate biological targets, and to increase the understanding of molecular pathways involved in the disease to identify new potential therapeutic targets. The initiative will deposit all data in a repository that will be accessible for use by the biomedical community. The five year endeavor, beginning in 2014, will result in several sets of project outcomes. For the biomarkers project, tau imaging and EEG data will be released in year two, as baseline data becomes available. Completed data from the randomized, blinded trials will be added after the end of the five year studies. This will include both imaging data and data from blood and spinal fluid biomarker studies. For the network analysis project, each project will general several network models of late onset AD (LOAD) and identify key drivers of disease pathogensis by the end of year three. Years four and five will be dedicated to validating the novel targets and refining the network models of LOAD, including screening novel compounds or drugs already in use for other conditions that may have the ability to modulate the likely targets.

Proper citation: Accelerating Medicines Partnership - Alzheimers (RRID:SCR_003742) Copy   

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http://www.cimit.org/

A non-profit consortium of Boston academic medical centers and universities (and growing) to accelerate the healthcare innovation cycle by fostering interdisciplinary, inter-institutional collaboration among experts in translational research, medicine, science, engineering, healthcare implementation and entrepreneurship in concert with industry, foundations and government to rapidly improve patient care. It concentrates on early stage, high-risk ideas, projects and supports them through to a commercial exit from academia. It provides innovators with resources to explore, develop and implement novel technological solutions for today's most urgent healthcare problems. CIMIT is dedicated to helping develop medical technology that will help both military and civilian patients.

Proper citation: Center for Integration of Medicine and Innovative Technology (RRID:SCR_003710) Copy   

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http://www.atheroremo.org/

Project targeting vulnerable plaques causing unexpected acute myocardial infarcts and sudden cardiac deaths by identifying and validating novel drug targets as well as devising and validating diagnostic tests. It has been designed to advance the present knowledge on the role of inflammatory remodeling in the different stages of atherosclerosis. It will also provide important knowledge for the development of strategies for prevention and clinical management of vascular diseases.

Proper citation: AtheroRemo (RRID:SCR_003831) Copy   

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http://c3nproject.org/

Project designing, prototyping, optimizing, and evaluating a learning health system to improve clinical practice, patient self-management, and disease outcomes of patients with chronic illness. This open, peer production system combines the collective input of patients, clinicians and researchers. It combines large clinical data registries with patient entered data and makes them accessible and interactive. A platform allows researchers to design, test and implement new knowledge and innovations in patient care. To test their platform approach, C3N is working on a model of treating children with Inflammatory Bowel Disease using the ImproveCareNow Network of pediatric clinics. Following this demonstration phase, the goal is to apply the social, scientific and technical platform to transform the care of a variety of chronic illnesses. The C3N effort has the following goals: # Deploy and optimize an integrated set of engagement tools to make it easier for patients and care providers to collect and use the right information during the clinical encounter and in between visits. # Prototype novel interventions to re-design care delivery by promoting the development of tools for real-time and dynamic population management, "just-in time" scheduling of visits, virtual clinic visits, and measuring the impact of these interventions on health, care, and cost. # Pilot and deploy patient-focused technology to improve the flow of data between patients, clinicians and scientists to enable faster learning and improvement.

Proper citation: Collaborative Chronic Care Network (RRID:SCR_003708) Copy   

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http://www.innomed-addneuromed.com/

THIS RESOURCE IS NO LONGER IN SERVICE. Documented on January 9,2023. Project portal for a cross European study designed to find biomarkers, or tests, for Alzheimer's disease. Its objectives are to produce and improve experimental models of Alzheimer's for biomarker discovery and to identify a biomarker for Alzheimer's disease suitable for diagnosis, prediction, and monitoring disease progression for use in clinical trials and in clinical practice. The baseline dataset database was scheduled to be completed and locked in 2008 and become available to researchers by 2009. Requests to access the data will be reviewed by the scientific projects committee.

Proper citation: AddNeuroMed (RRID:SCR_003819) Copy   

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http://www.mrc-cbu.cam.ac.uk/

Unit studying human cognition and the brain with about 90 researchers and postgraduate students investigating topics such as attention, emotion, language and memory. They are developing new treatments for depression, improving hearing through cochlear implants, and helping children to overcome memory problems. With a large collection of scientists engaged in both basic and translational research on the mind and brain, the Unit provides an exceptional training and academic environment that benefits postgraduate students and researchers at all levels. A significant part of their research makes use of brain imaging and they have excellent on-site facilities for magnetic resonance imaging (MRI) magnetoencephalography (MEG) and electroencephalography (EEG). They also have clinical facilities at Addenbrooke's Hospital. The Unit has close links both with the hospital and with Cambridge University.

Proper citation: MRC Cognition and Brain Sciences Unit (RRID:SCR_003818) Copy   

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http://c-path.org/programs/pstc/

A public-private partnership to identify new and improved translational safety testing methods for use in nonclinical and clinical studies and submit them for formal regulatory qualification by the FDA (Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japanese Pharmaceutical and Medical Devices Agency). The current 19 corporate members of the consortium share internal experience with nonclinical and clinical safety biomarkers in six working groups: cardiac hypertrophy, nephrotoxicity, hepatotoxicity, skeletal myopathy, testicular toxicity, and vascular injury. The ultimate goal of the consortium is to improve the current approach to drug safety testing and offer assurance to the drug developers that these approaches will be accepted by the regulatory authorities in their drug development programs. Through PSTC, members are able to share their expertise, resources, data, and internally developed approaches in a neutral, precompetitive, confidential environment. There are more than 250 participating scientists and C-Path serves as the trusted third party, leading the collaborative process by collecting and summarizing the data, and leading the interactions with global health authorities.

Proper citation: Predictive Safety Testing Consortium (RRID:SCR_003727) Copy   

•   Source: SciCrunch Registry

http://ispy2.org/

A collaboration to test an adaptive clinical trial model that would assess the efficacy of a candidate therapeutic earlier than traditional clinical trials, potentially enabling drugs to be developed and approved using fewer patients, less time and fewer resources. This trial focuses on women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone. It uses genetic and biological markers from individual patients' tumors to screen several promising new treatments simultaneously and allows doctors to quickly measure the effectiveness of the treatment prior to removing the tumor. The experimental adaptive trial design uses patient outcomes to immediately inform treatment options for subsequent trial participants. The trial has 5 components that differentiate it from conventional clinical trial models. # I-SPY2 uses tissue and imaging biomarkers from individual cancer patients' tumors to determine eligibility, guide/screen promising new treatments and identify which treatments are most effective in specific tumor subtypes. # The trial's adaptive design allows the Team to learn as they go, enabling researchers to use data from patients early in the trial to guide decisions about which treatments might be more useful for patients who enter the trial earlier. I-SPY2 provides a scientific basis for researchers to eliminate ineffective treatments and graduate effective treatments more quickly. # The neoadjuvant treatment approach - in which chemotherapy is given to patients prior to surgery - allow the team to evaluate tumor response with MRI before removal. This approach is safe as treating after surgery, allowing tumors to shrink, and more importantly, it enables critical learning early on about how well treatments work. # The ability for the team to screen multiple drug candidates developed by multiple companies. New agents will be selected and added as those used initially and either graduate to Phase III, or are dropped, based on their efficacy in targeted patients. # The trials informatics system allows data to be collected, verified, and shared in real-time. This allows data to be assessed early and in an integrated fashion - with an aim to enhance and encourage collaboration

Proper citation: I-SPY 2 TRIAL (RRID:SCR_003713) Copy   

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http://dc-research.eu/

An open knowledge resource for the dendritic cell research community, this index of research assets and expertise is designed to support translational research by providing annotations and interrelations on materials, datasets, tools, techniques, persons and organizations. The content of DC-RESEARCH.EU can be accessed by researchers through its website and can be accessed programmatically: the information in DC-RESEARCH.EU is represented through machine processable languages, proper of the Semantic Web (RDF and RDFa). To submit to the dc-thera directory please contact: dc-research_at_leafbioscience.com

Proper citation: DC-Research.eu - Dendritic Cell Research Knowledge Portal (RRID:SCR_004200) Copy   

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http://www.transformproject.eu/portfolio-item/d6-3-data-integration-models/

A set of three models, which in conjunction with the semantic mediator enables the execution of queries formulated through the eligibility representation of the Clinical research information model (WT6.4). An ontology-driven mechanism was developed to enable linkage and integration of phenotypic and genotypic data from multiple distributed data sources. It makes use of the Clinical Data Integration Model (CDIM, WT6.5), the Data Source Model (DSM, WT6.6) and the CDIM-DSM mapping model (WT6.6). Queries formulated through the CDIM and vocabulary service (WT7.2) are translated to local queries by the mediator using the individual source instances of the DSM and CDIM-DSM models.

Proper citation: TRANSFoRm Data Integration Models (RRID:SCR_003892) Copy   

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http://www.onestudy.org/

Consortium aiming to produce regulatory T cells that are compatible with a kidney transplant patient''''s immune system, as a measure to suppress the body''''s natural immune response against a transplanted organ. If successful, this approach will reduce a transplantation patient''''s life-long dependency on immune suppressing drugs, many of which are often associated with undesirable side effects and can limit the patient''''s daily routine. The consortium goals are to develop and conduct clinical trials of various immunoregulatory T-cell-based products in organ transplantation recipients, allowing a direct comparison of the safety, clinical practicality and therapeutic efficacy of each cell type. The central focus of the project is to: # Production and manufacture of distinct populations of hematopoietic immunoregulatory T cells # Comparatively study the tolerogenic characteristics of these regulatory cell types # Test these cell therapy products side by side in a clinical trial living donor renal transplant recipients The first workstream will work with different T regulatory cell, tolerogenic DC and suppressive macrophage cell products that are currently in development. In addition to these therapeutics, another goal of this workstream is to develop a cell tracking technology that assesses pharmacodynamics and pharmacokinetics of these cell-based therapies. The second workstream is focused on designing and conducting a cell therapy based clinical trial in renal transplantation, taking into consideration ethics, concurrent immunosuppressive drug use, state-of-the-art immune monitoring, innovative all-in-one data capturing systems, and pharmacovigilance. The goal is to have a comparative evaluation of hematopoietic cell therapy safety in renal transplantation. The third workstream aims to learn more about the specific comparative characteristics of suppressive cell types and to use this knowledge to improve later trial designs and foster novel ideas for new or improved suppressive / tolerogenic cell population.

Proper citation: ONE Study (RRID:SCR_003886) Copy   

•   Source: SciCrunch Registry

http://www.transformproject.eu/wp-content/uploads/documents/cdim.owl

A global mediation model expressed as an ontology for use in the primary care domain. It uses a realist approach employing Basic Formal Ontology (BFO v1.1) as an upper ontology. Other ontologies were imported or specialized to give deeper definition to the concepts in the domain. These included OGMS, IAO and VSO. The CDIM ontology includes concepts that are especially important to primary care (e.g. episode of care or reason for encounter), but also others to handle temporality in queries (e.g. the start and beginning of processes). The owl file provided for download is the merged file created directly in Prot��g�� through the Refactor/Merge ontologies tool in order to facilitate the load of CDIM in LexEVS for use in the unified interoperability framework.

Proper citation: TRANSFoRm Clinical Data Integration Model (RRID:SCR_003885) Copy   

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http://www.orbitoproject.eu/

Project that aims to increase understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients over a range of clinically relevant conditions. The integration of in vitro and in silico approaches will provide a biopharmaceutics toolkit, validated using clinical data, to accelerate drug development. Ultimately, the project will help to facilitate and speed up the formulation development process and significantly reduce the need for animal experiments in this area as well as for human clinical studies in the future. For patients, the main benefit will be in the form of high quality medicines where the dose required is well calculated and is released in a way that consistently provides an optimal clinical effect.

Proper citation: ORBITO (RRID:SCR_003876) Copy   

•   Source: SciCrunch Registry

https://brightoncollaboration.org/

A non-profit partnership and global research network providing high quality vaccine safety information. Their mission is to enhance the science of vaccine research by providing standardized, validated, and objective methods for monitoring safety profiles and benefit to risk ratios of vaccines. Products and services to promote high quality vaccine safety research include: * Standardized case definitions of adverse events following immunization * Guidelines for collection, analysis, and presentation of vaccine safety data * Template protocols for vaccine safety research * Automatic Case Classification Tool (ABC tool) * Library of vaccine safety publications * Links to high quality vaccine safety resources * Vaccine Safety Quarterly - Newsletter

Proper citation: Brighton Collaboration (RRID:SCR_004089) Copy   

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http://www.asdin.org/

Society that aims to promote the proper application of new and existing procedures to improve the care of patients with kidney disease. They promote education, research, public policy and clinical practice initiatives relating to diagnostic and interventional procedures. ASDIN works closely with other societies and programs to achieve its goals. All professionals involved in the care of patients with kidney disease are welcome to join and become active in the Society. Activities of the Society include: * the establishment of practice standards, * certification of physicians in specific procedures, * accreditation of training programs in specific procedures, * development of training tools and techniques, * sponsoring symposia and training courses, * and the dissemination of information through periodic meetings and through print and other media.

Proper citation: American Society of Diagnostic and Interventional Nephrology (RRID:SCR_003968) Copy   

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https://www.trainingconsortium.asia/

Consortium of pharmaceutical companies and clinical research organizations, plus one regional association, that are pooling their resources to deliver quality training courses for clinical research professionals in the Asia Pacific region. The collaborative training initiatives aim to resolve issues of redundant and duplicate trainings, less than optimal class sizes and lower than ideal training frequencies, all of which are prevalent in the region. ATC also hopes to significantly enhance the number and quality of professionals to meet the resource demands of the globalized industry. The first target audience would be clinical trial investigators and clinical trial management staff - with priorities provided to clinical trial associates, clinical trial project managers, and clinical research managers. As of 2014, 900 days of ATC courses have been taught in classrooms throughout Asia. The ATC''s Foundations of Clinical Project Management is a regularly offered in Shanghai and is available on-line in English and Mandarin.

Proper citation: Asia Training Consortium (RRID:SCR_004014) Copy   

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http://www.eortc.org/clinical-trials

A database that contains information about EORTC (European Organisation for Research and Treatment of Cancer) clinical trials but also clinical trials from other organizations, in which EORTC has been/is participating. The protocol database may be browsed by EORTC Research Group, tumor site, treatment, or drug.

Proper citation: EORTC Clinical Trials (RRID:SCR_004011) Copy   

•   Source: SciCrunch Registry

http://jdrfconsortium.jaeb.org/

Consortium aiming to accelerate the development of systems for automated control of blood glucose in patients with diabetes. Consortium investigators seek to research and develop strategies, which can be commercialized, that will confer the long-term benefits of improved glycemic control by combining novel automated control algorithms and hormone therapies with continuous glucose monitors and pump devices. The field of closed-loop artificial pancreas research requires expert diabetologists partnering with expert mathematicians and engineers. Consortium investigators include endocrinologists and control theorists at research institutions in the US and in Europe. Many of the diabetes device manufacturers have also participated, providing pumps and sensors with enhanced capabilities that allow for closed-loop experiments to be performed. The goals of the consortium include: * Design, optimization, and clinical testing of multiple algorithmic approaches to closed-loop control * An in silico simulation platform, accepted by the FDA, for validating candidate closed-loop control algorithms in place of animal trials * Reusable templates for constructing the Investigational Device Exemption regulatory documents that must be approved by the FDA prior to any in-clinic, computer-assisted, closed-loop control research involving people * A modular software platform-the Artificial Pancreas System-with a protocol-independent user interface and hooks to incorporate an arbitrary control algorithm and control various continuous glucose monitors and pump devices * A secure consortium Web site with a central repository for experimental data and interfaces to submit candidate control algorithms for centralized validation and to upload or download clinical data sets * the first outpatient studies of an overnight controller * the first outpatient studies of a hypoglycemia minimization strategy * the development and testing of a modular treat-to-range closed-loop approach * multiple studies of dual hormone (insulin and glucagon) devices and a means to improve insulin kinetics Ongoing and recently completed in-clinic studies at the end of 2011 include investigations into hypoglycemia prediction and avoidance as well as fully-automated closed-loop control investigations using MPC and PID/PD-based algorithms. The most recent developments include the first-ever feasibility trials of portable, outpatient-based closed-loop control systems.

Proper citation: JDRF Artificial Pancreas Project Consortium (RRID:SCR_004010) Copy   

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https://open.med.harvard.edu/display/SHRINE/Community

Software providing a scalable query and aggregation mechanism that enables federated queries across many independently operated patient databases. This platform enables clinical researchers to solve the problem of identifying sufficient numbers of patients to include in their studies by querying across distributed hospital electronic medical record systems. Through the use of a federated network protocol, SHRINE allows investigators to see limited data about patients meeting their study criteria without compromising patient privacy. This software should greatly enable population-based research, assessment of potential clinical trials cohorts, and hypothesis formation for followup study by combining the EHR assets across the hospital system. In order to obtain the maximum number of cases representing the study population, it is useful to aggregate patient facts across as many sites as possible. Cutting across institutional boundaries necessitates that each hospital IRB remain in control, and that their local authority is recognized for each and every request for patient data. The independence, ownership, and legal responsibilities of hospitals predetermines a decentralized technical approach, such as a federated query over locally controlled databases. The application comes with the SHRINE Core Ontology but it can be used with any ontology, even one that is disease specific. The Core Ontology is designed to enable the widest range of studies possible using facts gathered in the EMR during routine patient care. SHRINE allows multiple ontologies to be used for different research purposes on the same installed systems.

Proper citation: SHRINE (RRID:SCR_006293) Copy   

•   Source: SciCrunch Registry