The discovery of clinical insights through effective management and reuse of data requires several conditions to be optimized: Data need to be digital, data need to be structured, and data need to be standardized in terms of metadata and ontology. This presentation describes a bioinformatics system that combines a next-generation biobank management model mapped to applicable international standards and guidelines with a master ontology that controls all input and output and is able to add unique properties to meet the specialized needs of clinicians for cross-disease research.
The document discusses two scientific journals - the Journal of Laboratory Automation (JALA) and the Journal of Biomolecular Screening (JBS). It provides information on their editors, impact factors, indexing in databases, scientific advisors and editorial boards. The goal of both journals is to publish research applying technological advances to scientific exploration and discovery of new therapeutics. Authors are encouraged to submit their work to these peer-reviewed, MEDLINE-indexed journals.
This paper describes the methods of the Treatment In Morning versus Evening (TIME) study, a large prospective randomized open-label blinded endpoint study comparing morning versus evening dosing of antihypertensive medications. The TIME study recruits participants through advertising, primary and secondary care, and patient databases in the UK. Participants self-enroll and consent on a secure website, and are randomized to morning or evening dosing. Follow-ups are conducted by automated email at 1 month and every 3 months thereafter. The study uses a prospective randomized open-label blinded endpoint design to establish if evening dosing is more cardioprotective than morning dosing.
The document discusses Peter Embi's approach to presenting on clinical and translational research informatics literature from the past year. It provides an overview of Embi's search strategy and categorization of papers, which involved searching literature databases and recommendations from colleagues. The presentation will focus on summarizing representative papers within categories like data sharing/reuse, methods and systems, recruitment and eligibility, and trends in clinical research informatics.
Clinical analytics–innovating to support clinical research
Clinical research informatics involves using informatics tools to support clinical research activities like managing clinical trials data and conducting secondary research using clinical data. It can help make clinical trials more efficient by facilitating study design, subject recruitment from electronic medical records and social media, data collection and management, and data analysis. National initiatives aim to develop informatics tools and networks to help researchers access data and accelerate clinical research.
NegBio: a high-performance tool for negation and uncertainty detection in rad...
NegBio is a tool that detects negation and uncertainty in radiology reports with high accuracy. It first uses MetaMap to map report text to medical concepts, then applies dependency parsing and rules to identify negative and equivocal findings. Evaluated on several datasets, NegBio significantly outperformed previous state-of-the-art methods, achieving F-scores over 95% in some cases. Future work includes exploring its use in other clinical texts beyond radiology reports. NegBio is available as open source software.
The Clinical and Molecular Epidemiology Shared Resource (CMESR) provides services including the collection, processing, and storage of biological samples and clinical data from various cancer patient populations. It assists with IRB protocols, questionnaire data entry and analysis, and sample and data requests for cancer research. The CMESR is located at the Lombardi Cancer Center and houses samples and data on prostate, head and neck, colon, lung, and breast cancers.
The document discusses the importance of standardized practices and quality control for biobanks in order to facilitate research using human biosamples. It notes that the UC system's biobanks currently use diverse practices. The UC Biobanking and Research Integration Across Disciplines (BRAID) working group aims to establish standards to recognize high-quality biobanks within the UC system and help them share samples.
Provenance abstraction for implementing security: Learning Health System and ...
Discussion of provenance usage in the Learning Health System paradigm, as implemented in the TRANSFoRm project, with focus on security requirements and how they can be addressed using provenance graph abstraction.
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analy...
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analytical Capabilities with Knowledge Content
Sirimon Ocharoen, Thomson Reuters
To effectively analyze data in tranSMART, biological analysis/knowledge-based approach is needed. Through a case study, we will demonstrate how system biology content can be integrated in tranSMART to enable functional analysis and biological interpretation. We will also share our experience and user feedbacks from various projects.
An overview of the oncology clinical trials network (CTNeT) which is being implemented throughout Texas.
The non-profit network is a first of its kind and combines the innovative science of Texas cancer centers with the expertise and resources of both academic and community oncologists throughout the state.
To learn more, visit www.ctnet.org
Diagnostic criteria and clinical guidelines standardization to automate case ...
This document discusses standardizing clinical guidelines for adverse event classification using the Adverse Event Reporting Ontology (AERO). It describes how AERO encodes guidelines like Brighton Collaboration for diagnosing conditions like anaphylaxis from vaccine reports. It also discusses how AERO can integrate data like classifying reports in the Vaccine Adverse Event Reporting System according to encoded guidelines and linking to other datasets like DrugBank. The goal is automated adverse event diagnosis and integration of reporting data.
Bryan Soper has extensive experience in pharmaceutical competitive intelligence, medical writing, and data analysis. He currently performs contract work analyzing clinical trials and assessing drug approval likelihoods for Genentech. Previously he has analyzed cancer models and clinical trials to identify correlations. He holds a PhD in Molecular Biology from Cornell University and has worked as a postdoctoral scholar at UCSF investigating drug targets.
Radiomics Data Management, Computation, and Analysis for QIN F2F 2016
Large Scale Data Management Computation and Analysis for Quantitative Imaging Research
Talk at the 2016 QIN Annual Meeting — covers resources developed for the Quantitative Imaging Network. Includes TCIA data curation, APIs, supported data types, as well as co-located computing and systematic phenotyping of imaging biomarkers
Cytology errors - Identifying them/preventing them - presentation by Steven Raab
This document summarizes a presentation on errors in non-gynaecological cytology and methods for their identification and prevention. It discusses different types of errors, methods for error detection including cytologic-histologic correlation, and data on error frequencies from multiple institutions. Common error sites included lung, bladder, and thyroid specimens. Root cause analysis found sources of error included interpretive issues, sampling errors, and lack of communication between clinicians and pathologists. Quality improvement approaches discussed standardized diagnostics, improved specimen adequacy assessments, and immediate specimen interpretation. A case study on thyroid FNA errors found interventions like standardized diagnoses and immediate interpretation improved sensitivity and reduced non-interpretability and atypical diagnoses.
Epic EMR to OMOP CDM to Clinical Research Data Mart: an Unmaintained Road or ...
Poster we presented at 2017 AMIA Joint Summits on Clinical and Translational Research Informatics.
In this research data delivery project, we explored a less traveled path of building a clinical data mart for a registry study on kidney transplant patients, based on the institutional instance of the EMR data, translated into the OMOP (Observational Medical Outcomes Partnership) common data model.
Zhuang Wan has over 10 years of experience in biostatistics and clinical research. She holds a Master's degree in Epidemiology and Biostatistics and has worked as a consultant and research associate at various universities and cancer centers. Her roles have included collaborating with clinicians on study designs, statistical analysis, and manuscript preparation. She has extensive experience leading statistical analysis for clinical trials in areas such as cancer, ophthalmology, and infectious disease.
Clinical Research Informatics (CRI) Year-in-Review 2014Peter Embi
Peter Embi's review of notable publications and events in the field of Clinical Research Informatics (CRI) that took place in 2013+. This was presented as the closing keynote presentation of the 2014 AMIA CRI Summit in San Francisco, CA on April 11, 2014.
Peter Embi's 2011 AMIA CRI Year-in-ReviewPeter Embi
This document discusses Peter Embi's presentation on clinical research informatics. The presentation included summaries of 22 research papers on topics like data warehousing and knowledge discovery, researcher support and resources, and recruitment informatics. It also discussed ongoing efforts to integrate informatics approaches and resources to support clinical and translational research.
The document discusses two scientific journals - the Journal of Laboratory Automation (JALA) and the Journal of Biomolecular Screening (JBS). It provides information on their editors, impact factors, indexing in databases, scientific advisors and editorial boards. The goal of both journals is to publish research applying technological advances to scientific exploration and discovery of new therapeutics. Authors are encouraged to submit their work to these peer-reviewed, MEDLINE-indexed journals.
This paper describes the methods of the Treatment In Morning versus Evening (TIME) study, a large prospective randomized open-label blinded endpoint study comparing morning versus evening dosing of antihypertensive medications. The TIME study recruits participants through advertising, primary and secondary care, and patient databases in the UK. Participants self-enroll and consent on a secure website, and are randomized to morning or evening dosing. Follow-ups are conducted by automated email at 1 month and every 3 months thereafter. The study uses a prospective randomized open-label blinded endpoint design to establish if evening dosing is more cardioprotective than morning dosing.
The document discusses Peter Embi's approach to presenting on clinical and translational research informatics literature from the past year. It provides an overview of Embi's search strategy and categorization of papers, which involved searching literature databases and recommendations from colleagues. The presentation will focus on summarizing representative papers within categories like data sharing/reuse, methods and systems, recruitment and eligibility, and trends in clinical research informatics.
Clinical research informatics involves using informatics tools to support clinical research activities like managing clinical trials data and conducting secondary research using clinical data. It can help make clinical trials more efficient by facilitating study design, subject recruitment from electronic medical records and social media, data collection and management, and data analysis. National initiatives aim to develop informatics tools and networks to help researchers access data and accelerate clinical research.
NegBio: a high-performance tool for negation and uncertainty detection in rad...Yifan Peng
NegBio is a tool that detects negation and uncertainty in radiology reports with high accuracy. It first uses MetaMap to map report text to medical concepts, then applies dependency parsing and rules to identify negative and equivocal findings. Evaluated on several datasets, NegBio significantly outperformed previous state-of-the-art methods, achieving F-scores over 95% in some cases. Future work includes exploring its use in other clinical texts beyond radiology reports. NegBio is available as open source software.
The Clinical and Molecular Epidemiology Shared Resource (CMESR) provides services including the collection, processing, and storage of biological samples and clinical data from various cancer patient populations. It assists with IRB protocols, questionnaire data entry and analysis, and sample and data requests for cancer research. The CMESR is located at the Lombardi Cancer Center and houses samples and data on prostate, head and neck, colon, lung, and breast cancers.
The document discusses the importance of standardized practices and quality control for biobanks in order to facilitate research using human biosamples. It notes that the UC system's biobanks currently use diverse practices. The UC Biobanking and Research Integration Across Disciplines (BRAID) working group aims to establish standards to recognize high-quality biobanks within the UC system and help them share samples.
Provenance abstraction for implementing security: Learning Health System and ...Vasa Curcin
Discussion of provenance usage in the Learning Health System paradigm, as implemented in the TRANSFoRm project, with focus on security requirements and how they can be addressed using provenance graph abstraction.
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analy...David Peyruc
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Advancing tranSMART Analytical Capabilities with Knowledge Content
Sirimon Ocharoen, Thomson Reuters
To effectively analyze data in tranSMART, biological analysis/knowledge-based approach is needed. Through a case study, we will demonstrate how system biology content can be integrated in tranSMART to enable functional analysis and biological interpretation. We will also share our experience and user feedbacks from various projects.
An overview of the oncology clinical trials network (CTNeT) which is being implemented throughout Texas.
The non-profit network is a first of its kind and combines the innovative science of Texas cancer centers with the expertise and resources of both academic and community oncologists throughout the state.
To learn more, visit www.ctnet.org
Diagnostic criteria and clinical guidelines standardization to automate case ...Melanie Courtot
This document discusses standardizing clinical guidelines for adverse event classification using the Adverse Event Reporting Ontology (AERO). It describes how AERO encodes guidelines like Brighton Collaboration for diagnosing conditions like anaphylaxis from vaccine reports. It also discusses how AERO can integrate data like classifying reports in the Vaccine Adverse Event Reporting System according to encoded guidelines and linking to other datasets like DrugBank. The goal is automated adverse event diagnosis and integration of reporting data.
Bryan Soper has extensive experience in pharmaceutical competitive intelligence, medical writing, and data analysis. He currently performs contract work analyzing clinical trials and assessing drug approval likelihoods for Genentech. Previously he has analyzed cancer models and clinical trials to identify correlations. He holds a PhD in Molecular Biology from Cornell University and has worked as a postdoctoral scholar at UCSF investigating drug targets.
Radiomics Data Management, Computation, and Analysis for QIN F2F 2016Ashish Sharma
Large Scale Data Management Computation and Analysis for Quantitative Imaging Research
Talk at the 2016 QIN Annual Meeting — covers resources developed for the Quantitative Imaging Network. Includes TCIA data curation, APIs, supported data types, as well as co-located computing and systematic phenotyping of imaging biomarkers
Cytology errors - Identifying them/preventing them - presentation by Steven RaabSusan Silver
This document summarizes a presentation on errors in non-gynaecological cytology and methods for their identification and prevention. It discusses different types of errors, methods for error detection including cytologic-histologic correlation, and data on error frequencies from multiple institutions. Common error sites included lung, bladder, and thyroid specimens. Root cause analysis found sources of error included interpretive issues, sampling errors, and lack of communication between clinicians and pathologists. Quality improvement approaches discussed standardized diagnostics, improved specimen adequacy assessments, and immediate specimen interpretation. A case study on thyroid FNA errors found interventions like standardized diagnoses and immediate interpretation improved sensitivity and reduced non-interpretability and atypical diagnoses.
Epic EMR to OMOP CDM to Clinical Research Data Mart: an Unmaintained Road or ...Oksana Gologorskaya
Poster we presented at 2017 AMIA Joint Summits on Clinical and Translational Research Informatics.
In this research data delivery project, we explored a less traveled path of building a clinical data mart for a registry study on kidney transplant patients, based on the institutional instance of the EMR data, translated into the OMOP (Observational Medical Outcomes Partnership) common data model.
This document summarizes the GeT-RM Project and Browser, which collects and analyzes genetic variant data submitted by various clinical and research laboratories. It describes the project team members and submitting labs. It provides information on the types and platforms of tests conducted, validation methods used by labs, read count distributions, and gene-level concordance calculations. It also outlines future analyses, improvements to the browser, and inclusion of paralogous sequence variant data.
Leveraging Medical Health Record Data for Identifying Research Study Particip...SC CTSI at USC and CHLA
This document summarizes a webinar about applications for identifying research study participants from medical record data. It describes TriNetX, SHRINE, and i2b2 which allow searching for de-identified patient counts across various healthcare organizations. TriNetX provides counts to attract clinical trials while SHRINE and i2b2 allow searching within local hospitals. Users must complete regulatory training to access these tools for cohort discovery and study planning. The webinar covered how each system works and potential weaknesses in using medical record data for research recruitment.
1) Quantitative medicine uses large amounts of medical data and advanced analytics to determine the most effective treatment for individual patients based on their specific clinical profile and biomarkers. This approach can help reduce healthcare costs and improve outcomes compared to the traditional one-size-fits-all model.
2) However, realizing the promise of quantitative personalized medicine is challenging due to the huge quantities of diverse medical data located in dispersed systems, lack of computing capabilities, and barriers to data sharing.
3) Grid and service-oriented computing approaches are helping to address these challenges by enabling federated querying, analysis, and sharing of medical data and services across organizations through virtual integration rather than true consolidation.
Using real-world evidence to investigate clinical research questionsKarin Verspoor
Adoption of electronic health records to document extensive clinical information brings with it the opportunity to utilise that information to support clinical research, and ultimately to support clinical decision making. In this talk, I discuss both these opportunities and the challenges that we face when working with real-world clinical data, and introduce some of the strategies that we are adopting to make this data more usable, and to extract more value from it. I specifically discuss the use of natural language processing to transform clinical documentation into structured data for this purpose.
Combining Patient Records, Genomic Data and Environmental Data to Enable Tran...Perficient, Inc.
The average academic research organization (ARO) and hospital has many systems that house patient-related information, such as patient records and genomic data. Combining data from a variety of sources in an ongoing manner can enable complex and meaningful querying, reporting and analysis for the purposes of improving patient safety and care, boosting operational efficiency, and supporting personalized medicine initiatives.
In this webinar, Perficient’s Mike Grossman, a director of clinical data warehousing and analytics, and Martin Sizemore, a healthcare strategist, discussed:
-How AROs and hospitals can benefit from a systematic approach to combining data from diverse systems and utilizing a suite of data extraction, reporting, and analytical tools, in order to support a wide variety of needs and requests
-Examples of proposed solutions to real-life challenges AROs and hospitals often encounter
Pine Biotech - a company that merges big -omics data analysis with clinical care and precision applications for Real World Evidence: research & development of new targets and therapeutics, stratified clinical trials, and development of biomarkers for early detection and companion diagnostics. We want to improve patient outcomes and provide tools for researchers and clinicians to have an impact on healthcare.
Next generation electronic medical records and search a test implementation i...lucenerevolution
Presented by David Piraino, Chief Imaging Information Officer, Imaging Institute Cleveland Clinic, Cleveland Clinic
& Daniel Palmer, Chief Imaging Information Officer, Imaging Institute Cleveland Clinic, Cleveland Clinic
Most patient specifc medical information is document oriented with varying amounts of associated meta-data. Most of pateint medical information is textual and semi-structured. Electronic Medical Record Systems (EMR) are not optimized to present the textual information to users in the most understandable ways. Present EMRs show information to the user in a reverse time oriented patient specific manner only. This talk discribes the construction and use of Solr search technologies to provide relevant historical information at the point of care while intepreting radiology images.
Radiology reports over a 4 year period were extracted from our Radiology Information System (RIS) and passed through a text processing engine to extract the results, impression, exam description, location, history, and date. Fifteen cases reported during clinical practice were used as test cases to determine if ""similar"" historical cases were found . The results were evaluated by the number of searches that returned any result in less than 3 seconds and the number of cases that illustrated the questioned diagnosis in the top 10 results returned as determined by a bone and joint radiologist. Also methods to better optimize the search results were reviewed.
An average of 7.8 out of the 10 highest rated reports showed a similar case highly related to the present case. The best search showed 10 out of 10 cases that were good examples and the lowest match search showed 2 out of 10 cases that were good examples.The talk will highlight this specific use case and the issues and advances of using Solr search technology in medicine with focus on point of care applications.
Dr. Dennis Wang discusses possible ways to enable ML methods to be more powerful for discovery and to reduce ambiguity within translational medicine, allowing data-informed decision-making to deliver the next generation of diagnostics and therapeutics to patients quicker, at lowered costs, and at scale.
The talk by Dr. Dennis Wang was followed by a panel discussion with Mr. Albert Wang, M. Eng., Head, IT Business Partner, Translational Research & Technologies, Bristol-Myers Squibb.
Utilization of virtual microscopy in a cooperative group settingBIT002
The document discusses the use of virtual microscopy in cooperative cancer research groups. It summarizes the Research Informatics Core's role in developing digital pathology solutions to improve review times and access for cooperative groups like the Children's Oncology Group. Key applications discussed include the Virtual Imaging for Pathology, Education and Research (VIPER) system and efforts to integrate virtual microscopy with gene expression data through the Virtual Microscopy to Microarray (VM2M) project. Future goals include incorporating additional data types and developing more sophisticated analysis and search capabilities.
This document discusses Moffitt Cancer Center's Total Cancer Care program which aims to transform cancer care through a personalized approach. It involves collecting extensive clinical, molecular, and biospecimen data from patients over their lifetime to power research. The goals are to improve outcomes through early detection, personalized treatment, and clinical trials matching. Moffitt has established an extensive biorepository and informatics platform to integrate data from over 78,000 consented patients to enable precision oncology research.
- The document discusses the Total Cancer Care (TCC) approach at Moffitt Cancer Center, which aims to provide personalized cancer care through comprehensive data collection and analysis.
- TCC collects extensive clinical, genomic, treatment and outcomes data from over 78,000 consented patients to power research studies and clinical trials matching. Molecular profiling has been conducted on over 14,000 tumor samples.
- The TCC data is housed in a large integrated database and used by researchers for studies in areas like radiochemotherapy response, exome sequencing, immunology biomarkers, and cancer epidemiology.
- The database also helps clinicians identify eligible patients for clinical trials and develop evidence-based treatment pathways. The goal is to transform cancer
This document discusses the opportunities and challenges for pathologists in genomic medicine. It provides background on advances in genomic sequencing technologies and decreasing costs that are enabling widespread adoption of genomic medicine. While genomic analysis is starting to be used clinically today, challenges remain around developing clinical grade databases and bioinformatics tools, as well as uncertainty around regulatory standards, reporting and billing, and payment. The document argues that pathologists are well-positioned to play a leadership role in genomic medicine due to their expertise, and that advocacy efforts by organizations like CAP are important to support pathologists' role as genomic medicine evolves.
This document provides an overview of the November 2000 issue of JALA (Journal of Analytical Laboratories Automation). It describes the development of a novel robotic system for the New York Cancer Project biorepository in collaboration with the Medical Automation Research Center. The biorepository receives 50-100 blood samples per day which are processed robotically to extract, quantify, aliquot and store DNA, plasma and RNA to be accessible to investigators. The robotic system aims to provide rapid random access to the hundreds of thousands of DNA samples stored for high-throughput analysis in studies of gene-environment interactions and cancer risk.
CancerLinQ aims to harness big data to improve cancer care by learning from every patient. It faces challenges of integrating diverse data types from genomics to behaviors. Its goals are precision, personalized medicine through molecular profiling of individual cancers. As clinical trials enroll few patients, CancerLinQ would provide real-world data from electronic health records to uncover new insights. When deployed, it will analyze de-identified patient records to uncover care patterns, allow comparing care to guidelines and peers, and provide evidence-based guidance. This has the potential to improve outcomes for patients and quality for providers and researchers.
Clinical trial data wants to be free: Lessons from the ImmPort Immunology Dat...Barry Smith
Presentation to the Clinical and Research Ethics Seminar, Clinical and Translational Science Center, Buffalo, January 21, 2014
https://immport.niaid.nih.gov/
http://youtu.be/booqxkpvJMg
The document provides an overview of the University of California Health's data analytics platform which combines healthcare data from the six University of California medical centers. It includes details on the health data warehouse such as the total number of patients, types of data collected, and tools used. The platform aims to enable researchers across UC to conduct studies using the large collection of standardized clinical data.
Leveraging Text Classification Strategies for Clinical and Public Health Appl...Karin Verspoor
Human-generated text is a critical component of recorded clinical data, yet remains an under-utilised resource in clinical informatics applications due to minimal standards for sharing of unstructured data as well as concerns about patient privacy. Where we can access and analyse clinical text, we find that it provides a hugely valuable resource. In this talk, I will describe two projects where we have used text classification as the basis for addressing a clinical objective: (1) a syndromic surveillance project where the task is the monitoring of health and social media data sources for changes that indicate the onset of disease outbreaks, and (2) the analysis of hospital records to enable retrieval of specific disease cases, for monitoring of the hospital case mix as well as for construction of patient cohorts for clinical research studies. I will end by briefly discussing the huge potential for clinical text analysis to support changing the way modern medicine is practised.
Forum on Personalized Medicine: Challenges for the next decadeJoaquin Dopazo
Bioinformatics and Big Data in the era of Personalized Medicine
10th Anniversary Instituto Roche Forum on Personalized Medicine: Challenges for the next decade.
Santiago de Compostela (Spain), September 25th 2014
Similar to Ontology-Driven Clinical Intelligence: A Path from the Biobank to Cross-Disease Research (20)
Ontotext’s Clinical Trials Eligibility Design Assistant helps with one of the most challenging tasks in study design: selecting the proper patient population.
Westgard's rules and LJ (Levey Jennings) Charts.Reenaz Shaik
Quality Control is a process used to monitor and evaluate the analytical process that produces patients results. Planning, documenting and agreeing on a set of guidelines ensures quality.
Exploring Alternatives- Why Laparoscopy Isn't Always Best for Hydrosalpinx.pptxFFragrant
Not all women with hydrosalpinx should choose laparoscopy. Natural medicine Fuyan Pill can also be a nice option for patients, especially when they have fertility needs.
Veterinary Medicines Manufacturers in IndiaHeilsaa Care
Veterinary Medicines Manufacturers in India: We are living in the modern world, and with all modern advancements, we still rely on animals for eggs, milk, food, etc. Like humans, there is a huge need for veterinary healthcare products and medicines. And a large proportion of the Indian population is involved in animal husbandry and they would like to ensure quality medical treatment for their livestock.
Hepatocarcinoma today between guidelines and medical therapy. The role of sur...Gian Luca Grazi
Today more than ever, hepatocellular carcinoma therapy is experiencing profound and substantial changes.
The association atezolizumab (ATEZO) plus bevacizumab (BEVA) has demonstrated its effectiveness in the post-operative treatment of patients, improving the results that can be achieved with liver resections. This after the failure of the use of sorafenib in the already historic STORM study.
On the other hand, the prognostic classification of BCLC is now widely questioned. It is now well recognized that the indications for surgery for patients with hepatocellular carcinoma are certainly narrow in BCLC and no longer reflect what is common everyday clinical practice.
Today, the concept of multiparametric therapeutic hierarchy, which makes the management of patients with hepatocellular carcinoma much more flexible and allows the best therapy for the individual patient to be identified based on their clinical characteristics, is gaining more and more importance.
The presentation traces these profound changes that are taking place in recent years and offers a modern vision of the management of patients with hepatocellular carcinoma.
Top 10 Habits for Longevity [Biohacker Summit 2024]Olli Sovijärvi
Slides from my presentation in the 10th anniversary event of the Biohacker Summit 2024 in Helsinki. The theme of the whole event wast unifying science, technology and nature.
www.biohackersummit.com
Drug Repurposing for Parasitic Diseases.pptxdrebrahiim
, drug repurposing has emerged as a promising strategy for the treatment of parasitic diseases. Drug repurposing, or drug repositioning, involves identifying new therapeutic uses for existing drugs. This approach leverages the known safety profiles, established manufacturing processes, and previously conducted clinical trials of existing drugs, thereby significantly reducing the time and cost associated with bringing new treatments to market.
Ontology-Driven Clinical Intelligence: A Path from the Biobank to Cross-Disease Research
1. Ontology-Driven Clinical Intelligence
A Path from the Biobank to Cross-Disease Research
Bruce Pharr | Vice President, Bioinformatics Systems
Molecular Medicine Tri-Conference | February 11, 2014
1
2. Data Barriers to Clinical Research
Critical Data is Dispersed in Separate Systems
Disease A
Disease B
Considering the vast stores of clinical data available to potential
investigators, the actual amount of clinical research performed has
been quite modest. At many medical centers, the data are dispersed in
separate systems that have evolved independently of one another.
Source: Obstacles and Approaches to Clinical Database Research: Experience at the University of California, San Francisco
3. Removing the Data Barriers
Structured Digital Data with Standardized Metadata and Ontology
Disease A
Disease B
The discovery of scientific insights through
effective management and reuse of data
requires several conditions to be optimized:
• Data need to be digital;
• Data need to be structured;
• Data need to be standardized in terms of metadata and ontology.
Source: Anne E. Thessen and David J. Patterson, Data issues in life sciences, PMC (NIH/NLM) (November 28, 2011).
4. Ontology-Driven Clinical Intelligence
Structured Data with Standardized Metadata and Ontology
New Patient
Biobank
Lab Test & Analysis
Disease
Registry
Pre-analytical Data
Analytical Data
Mosaic™ Ontology-Based Platform
Legacy Data
Patient
Data
Legacy Disease Database
Patient
Data
5. Ontology-Driven Clinical Intelligence
Remedy Informatics Architecture
Patient
Data
New
Data
Patient
Data
Remedy Bioinformatics
RemedyAMH™
Biobank Management Informatics
Aggregate, Map & Harmonize
Legacy
Data
Mosaic Builder Applications
Patient
Data
Content and Registry Development
Mosaic Engine
Functional Layers: Physical, Data Model, Information Model, Ontology, Representation Model
Mosaic™ Platform
Remedy Informatics
Disease
Registry
6. Next-Gen Biobank
A Path from the Biobank to Cross-Disease Research
Patient
Data
New
Data
Remedy Bioinformatics
Biobank Management Informatics
Remedy Informatics
7. Biobank Growth and Upgrade Cycle
Drivers for Next-Gen Biobanks
Growth
33% of all biobanks have been installed since the early 2000s (HGP)
•
•
•
Increase in population genetics studies
Personalized medicine
Genetic information in food safety, forensics and disease surveillance
Upgrade
The Cancer Genome Atlas (TCGA) project (2006-8) exposed deficiencies
•
Many biobank managers didn’t know exactly what was in their freezers
•
Some specimens were unfit for analysis
•
•
Others had been obtained from patients without adequate consent
The rate of unacceptable shipments from some institutions was 99%
Source:
The
Future
of
Biobanking,
Laboratory
Focus,
January
2013
8. Next-Gen Biobank Management
Best Practices Model Mapped to Applicable Global Standards
Patient
Biobank
Manage all information about:
1. Specimens,
2. Patients, and
3. Operations throughout:
• Collection
• Processing
• Storage and Inventory
• Distribution
9. Best Practices
Biobank Management Informatics Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
Metadata
Entity Types
Sample Acquisition
Sample and Data Management
Sample Retention and Distribution
Support of Laboratory Processes
User Management
Search
Presentation of Entities
Printing
Reports and Audits
Non-functional Requirements
External Interface Requirements
10. Best Practices
Applicable International Standards and Guidelines
ISBER
International Society for Biological and Environmental Repositories. Best Practices for Repositories:
Collection, Storage, Retrieval, and Distribution of Biological Materials for Research.
NCI National Cancer Institute. First-generation guidelines for NCI-supported Biorepositories.
BAP Biorepository Accreditation Program (BAP) Checklist – College of American Pathologists (CAP)
21 CFR Part 11 US FDA – Guidelines on electronic records and electronic signatures.
45 CFR § 164.514 US HHS – Other requirements relating to uses and disclosures of protected health information.
ISO 15189 Medical laboratories – Particular requirements for quality and competence.
ISO 17025 General requirements for the competence of testing and calibration laboratories.
MoReq2 European Commission. Model Requirements for the management of electronic records.
OECD Best Practice Guidelines for biological resource centres.
Rec(2006)4
Council of Europe, Committee of Ministers. Recommendation of the Committee of Ministers to
member states on research on biological materials of human origin.
11. Mosaic Ontology
Purpose-Specific Structured Data Model
1. Predefined, Standardized Terminology
2. Domain-Specific Mapped Relationships
3. Permissible Values and Validation Rules
Patient
Data
Legacy
Data
RemedyAMH™
Aggregate, Map & Harmonize
Mosaic Builder Applications
Patient
Data
Content and Registry Development
Mosaic Engine
Functional Layers: Physical, Data Model, Information Model, Ontology, Representation Model
Mosaic Platform
Remedy Informatics
Disease
Registry
12. Mosaic Ontology
Predefined, Standardized Terminology
Lab Result
LOINC
Subject
Units
High End of Normal
Low End of Normal
Confidentiality
Validation Status
Validator
Supplier of Data
LOINC Medical Laboratory and Clinical Observations
13. Mosaic Ontology
Predefined, Standardized Terminology
Disorder
SNOMED CT
Assertion
Subject
Severity
Stage
Response to Treatment
Active State
Onset Date
Resolved State
First Diagnosed Date
Confidentiality
Source
Date of Entry
Validation Status
Validator
Supplier of Data
LOINC Medical Laboratory and Clinical Observations
SNOMED CT Clinical Codes, Terms, Synonyms and Definitions
14. Mosaic Ontology
Predefined, Standardized Terminology
LOINC Medical Laboratory and Clinical Observations
SNOMED CT Clinical Codes, Terms, Synonyms and Definitions
ICD Disease Classifications
Gene Ontology Gene Product Characteristics and Annotation
RxNorm Clinical Drug Classifications
CDISC Clinical Protocol, Analysis and Reporting
15. Mosaic Ontology
Domain-Specific Mapped Relationships
Lab Result
Disorder
Procedure
LOINC
SNOMED
SNOMED
Subject
Response to Tx
Cause
Subject
Units
High End of Normal
Assertion
Evidence for
Severity
Subject
Operator
Indication
Facility
Low End of Normal
Stage
Confidentiality
Response to Treatment
Validation Status
Active State
Intent
Onset Date
Confidentiality
Resolved State
Source
First Diagnosed Date
Date of Entry
Confidentiality
Validation Status
Source
Validator
Date of Entry
Supplier of Data
Validator
Supplier of Data
Has Result
Validation Status
Validator
Supplier of Data
Start-Stop Time
Contraindication
Urgency Status
16. Mosaic Ontology
Permissible Value and Validation Rules
Disorder
Procedure
SNOMED
SNOMED
Assertion
Subject
Mild
Subject
Operator
Moderate
Severity
Facility
Severe
Stage
Screening
Start-Stop Time
Response to Treatment
Diagnostic
Urgency Status
Active State
Prevention
Intent
Onset Date
Therapeutic
Confidentiality
Resolved State
Palliation
Source
First Diagnosed Date
End-of-Life
Date of Entry
Confidentiality
Validation Status
Source
Validator
Date of Entry
Supplier of Data
Validation Status
Validator
Supplier of Data
19. Remedy Informatics
• Founded in 2003, privately held.
• U.S. headquarters in Salt Lake City, Utah. Development offices in
Menlo Park, California.
• Satellite offices in London, England; Sao Paulo, Brazil; and Munich,
Germany.
• More than 120 employees.
• Strategic partnerships with Merck and IMS.
• Developed proprietary Mosaic Platform, an ontology-driven clinical
intelligence system scalable to any size enterprise.
• Delivered more than 120 registries to wide range of leading life sciences
research and healthcare delivery organizations.
20. Thanks! – Questions?
Bruce Pharr
Vice President, Bioinformatics Systems
bruce.pharr@remedyinformatics.com
Remedy Informatics
www.remedyinformatics.com
Booth 406