How can Natural Language Processing help MedDRA coding? April Andrew Winter Ph.D., Senior Life Science Specialist, Linguamatics
|
|
- Darcy McCoy
- 5 years ago
- Views:
Transcription
1 How can Natural Language Processing help MedDRA coding? April Andrew Winter Ph.D., Senior Life Science Specialist, Linguamatics
2 Summary About NLP and NLP in life sciences Uses of NLP with MedDRA Examples in MedDRA coding of adverse events in FDA drug labels How NLP could feed into MedDRA development 2
3 Use of NLP in Life Sciences Advanced text analytics delivers value along the pipeline Gene-disease mapping Regulatory Submission QC HEOR Target ID/selection Trial site selection and study design IDMP Pharmacovigilance Toxicity analysis and prediction Safety Competitive intelligence Mutation/expression analysis SAR Biomarker discovery Real World Evidence Comparative Effectiveness Drug repurposing Patent analysis KOL identification Opportunity scouting Voice of the Customer analysis Social media analysis 3
4 NLP Turns Text into Actionable Insights Transform unstructured or semi-structured data into insights to advance human health Turn text Into structured data using sophisticated queries To drive analytics Analytics Natural Language Processing Ontologies Statistical Methods Machine Learning - Chemistry Regular Expressions etc. Enterprise Warehouse 4
5 NLP finds information however it is expressed Different word, same meaning cyclosporine ciclosporin Neoral Sandimmune NLP Different expression, same meaning Non-smoker Does not smoke Does not drink or smoke Denies tobacco use Different grammar, same meaning 5mg/kg of cyclosporine per day 5mg/kg per day of cyclosporine cyclosporine 5mg/kg per day Same word, different context Diagnosed with diabetes Family history of diabetes No family history of diabetes 5
6 Blend of powerful rule- and machine learning-based methods to transform unstructured data into structured Linguistic Processing Terminologies/ Ontologies Precise linguistic relationships, sentence co-occurrence Precise negation e.g. pressure not blood pressure Multiple languages Search for concepts and their synonyms with spelling and optical character recognition (OCR) correction Out of the box or custom ontologies Quantitative Data Results Normalization Quantitative & pattern-based data extraction at scale e.g. numerical data, dates, gene mutations Range search Ontology and rule-based normalization of results Essential for organizing structured output Enables indirect relations, filtering/faceting results, etc. Chemistry Identify and extract chemicals in context based on substructure and chemical similarity Table & Region Processing Unique capability to capture knowledge from tables embedded in documents Fielded search within regions of a document 6
7 Data normalization: always treat the same concept in the same way the key to structured results Concept Text Normalized Value Diseases breast cancer Breast Neoplasm carcinoma of the breast Genes Raf-1 RAF1 Raf I Dates 27th Feb /02/27 Measurements 0.2g 200 mg Two hundred milligrams Mutations Val 158 Met V158M Behaviours Val by Met at codon 158 denies alcohol and tobacco use is not a cigarette smoker Non-smoker Data normalization Overview Convert text into a standard format Is a fundamental component in transforming text into structured data and driving actionable insights Key benefits Find concepts however they are expressed Join results to discover new indirect relationships Cluster or facet results by concept or quantity Compare measurements with different units e.g. kg vs. lbs Relationships...nimesulide, a selective COX2 inhibitor, inhibits Entrez ID:
8 Use of NLP with MedDRA Errors in Regulatory Submissions Social Media Adverse Events in Drug Labels 8
9 Table: Most Frequently Reported Medical Conditions ( 5% in Any Treatment Group) Study Total Number Subjects Cardiac disorders 70 (7.0) Angina pectoris 4 (0.4) Dyspepsia 174 (17.5) GERD 83 (8.3) Metabolic / nutritional disorders 2000 Pooled Studies Rx N=997 Pbo N=927 Rx N=1021 Number (%) of Subjects 253 (25.4) Dyslipedaemia 1 (0.1) Hypercholesterolaemia 65 (6.5) Hyperlipidaemia 147 (14.7) Osteoarthritis 102 (10.2) Nervous system disorders 628 (63.0) Headache 413 (41.4) Psychiatric disorders 137 (13.7) Insomnia 84 (8.4) 32 (3..5) 5 (0.5) 120 (12.9) 52 (5.6) 165 (17.8) 0 (0) 50 (5.4) 79 (8.5) 57 (6.6) 409 (44.1) 280 (30.2) 81 (8.7) 47 (5.1) 2003 Pooled Study 108 (10.6) 74 (7.2) 3 (0.3) 30 (2.9) 194 (19.0) 15 (1.5) 88 (8.6) 56 (5.5) 12 (1.2) 28 (2.7) 9 (0.9) 14 (1.4) 9 (0.9) Pbo N= (10.6) 71 (7.4) 2 (0.2) 27 (2.8%) 212 (22.2) 19 (2.0) 103 (10.8) 66 (6.9) 11 (1.2) 19 (2.0) 7 (0.7) 15 (1.6) 8 (0.8) Commonly reported conditions included Seasonal allergies, Back pain, and Hypercholesterolaemia. The majority of AEs were considered treatment related in all cohorts and the relationship between treatment groups and between cohorts was similar to that observed for all-causality AEs. Permanent discontinuations were reported at higher rates in the Rx groups than in the placebo groups in the 3 pooled cohorts. The majority of AEs leading to permanent discontinuation were considered treatment related in both treatment groups in all cohorts. The single most frequently reported event was headache, which was reported in approximately 40% of Rx subjects and 20% of placebo subjects in the 2000 Pooled cohort. Other AEs reported across all cohorts at rates greater in Rx subjects than placebo subjects included Seasonal allergies and Insomnia ( % vs 5.4%, % vs 0.8%, % vs 10.1%; Rx vs placebo respectively). Key Incorrect formatting: doubled period, incorrect number of decimal places, addition of percent sign Incorrect calculation: number of patients divided by total number does not agree with percent term Incorrect threshold: presence of row does not agree with table title Text-Table inconsistency: numbers in the table do not agree with numbers in the accompanying text Sample table and text highlighting, to show inconsistencies between data. The highlight colour makes it easy for the reviewer to rapidly assess where there are errors and what type of errors, and can then correct these appropriately. 9 Linguamatics 2016
10 Use Case: Automated Blinded Data Review for Regulatory Submissions Before unblinding a clinical trial, data are checked for errors and inconsistencies Among the many checks performed, MedDRA terms for Adverse Events Reports are verified, including: Is the Preferred Term valid in any version of MedDRA? Reporter may have inserted the Investigator Entry in the wrong field, or used an LLT Are multiple MedDRA versions in use in the same trial? Reporter Error or Error when generating the blinded data Does the specified version of MedDRA agree with the Preferred Terms being reported? Reporter may have used a more precise MedDRA term from a more recent version of MedDRA Does the Preferred Term agree with the declared System Organ Class? Automation of this process is in use at large pharma 10
11 Use Case: Social Media Analysis Social media: plenty of AEs mentioned Language informal Linguistic patterns can find mentions of AEs without using a dictionary Using MedDRA LLTs finds only one of the following 4 examples 11
12 Use Case: Extraction of Adverse Events using MedDRA Extraction of adverse events, MedDRA terms and frequency of occurrence, clustered by medicinal product Structured results can be used to populate a database, e.g. IDMP Different customers have different MedDRA requirements, e.g. PT vs LLT, which is easy to accommodate Results table (background) and highlighted source document (foreground) are shown 12
13 Extraction of AEs from FDA Drug Labels FDA drug labels are not structured Want to compare AEs found in Real World Evidence with known AEs Find AEs from within text, and within tables Pull out values if want to filter to only include AEs where greater than placebo 13
14 Use of NLP terminology features in extracting AEs Increase recall with: Morphological variants Spelling correction Matching across conjunctions Mapping multiple concepts to MedDRA PT Increase precision with: Excluding inappropriate contexts Use of document sections to exclude inappropriate terms 14
15 Increase recall: morpho variants MedDRA PT Congenital anomaly Additional hits when using morphological variants 15
16 Increase recall: spelling correction MedDRA PT Hypersensitivity 16
17 Increase recall: MedDRA matching across conjunctions MedDRA PT Hepatic neoplasm OR Thyroid neoplasm 17
18 Increase recall: mapping multiple concepts to a MedDRA PT MedDRA PT Blood creatinine increased Blood creatinine increased Creatinine blood increased Creatinine high Creatinine increased Creatinine serum increased Increased serum creatinine Plasma creatinine increased Raised serum creatinine Serum creatinine increased has low recall. Combining MedDRA PT Blood creatinine Blood creatinine Creatinine Plasma creatinine Serum creatinine with Relation Increase Increase Elevate Raise... in a linguistic pattern allowing flexibility in expression... gives significant additional recall (). 18
19 Increase precision: exclusion of hits in inappropriate contexts when searching for adverse events Thousands of examples of MedDRA concepts that are not AEs. Linguistic patterns can filter out inappropriate contexts. 19
20 Increase precision: using document regions - exclusion of PTs that occur in Indications when searching for AEs Can be removed based on same PT 20
21 How NLP could feed into MedDRA development: improved coverage of terminology Terms appearing with MedDRA terms in the same list Explicit constructions such as AEs such as, or from tables Look for terms in appropriate contexts e.g. made me? 21
22 Noun phrases occurring in a list after adverse events such as, and which are not already in MedDRA 22
23 Noun phrases occurring in the same list as another MedDRA term 23
24 Summary NLP is required to rule out inappropriate contexts, improving precision NLP techniques e.g. Morphological variants and OCR correction improve recall String based synonym matching cannot cope with all the variation found in real text, e.g. Elevation of blood creatinine. Here Linguistic patterns are required. Region and table processing are often required to get the right context. 24
Innovative Risk and Quality Solutions for Value-Based Care. Company Overview
Innovative Risk and Quality Solutions for Value-Based Care Company Overview Meet Talix Talix provides risk and quality solutions to help providers, payers and accountable care organizations address the
More informationMedDRA Coding/ AE Log Item 1 Refresher. ASPIRE Protocol Team Meeting February 10, 2013
MedDRA Coding/ AE Log Item 1 Refresher ASPIRE Protocol Team Meeting February 10, 2013 MedDRA Coding Overview MedDRA: standardized dictionary of medical terminology Results from ICH initiative to standardize
More informationMedDRA Overview A Standardized Terminology
MedDRA Overview A Standardized Terminology Patrick Revelle Director, MedDRA MSSO 6 May 2010 MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations
More informationText mining for lung cancer cases over large patient admission data. David Martinez, Lawrence Cavedon, Zaf Alam, Christopher Bain, Karin Verspoor
Text mining for lung cancer cases over large patient admission data David Martinez, Lawrence Cavedon, Zaf Alam, Christopher Bain, Karin Verspoor Opportunities for Biomedical Informatics Increasing roll-out
More informationBuilding Cognitive Computing for Healthcare
Building Cognitive Computing for Healthcare Boston University Digital Health Initiative Round Table February 27 th 2017 Patrick McNeillie M.D. Clinical Lead and Senior Architect on Watson for Genomics
More informationHow to Advance Beyond Regular Data with Text Analytics
Session #34 How to Advance Beyond Regular Data with Text Analytics Mike Dow Director, Product Development, Health Catalyst Carolyn Wong Simpkins, MD, PhD Chief Medical Informatics Officer, Health Catalyst
More informationWhat Smokers Who Switched to Vapor Products Tell Us About Themselves. Presented by Julie Woessner, J.D. CASAA National Policy Director
What Smokers Who Switched to Vapor Products Tell Us About Themselves Presented by Julie Woessner, J.D. CASAA National Policy Director The CASAA Consumer Testimonials Database Collection began in 2013 through
More informationTHE PHASE I/II CLINICAL TRIAL IN PATIENTS WITH BLADDER CANCER
HAMLET PHARMA NEWSLETTER THE PHASE I/II CLINICAL TRIAL IN PATIENTS WITH BLADDER CANCER The discovery of HAMLET defines a new class of cancer drugs with broad effects against cancers of different origin
More information2.0 Synopsis. ABT-711 M Clinical Study Report R&D/06/573. (For National Authority Use Only) to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Depakote ER Name of Active Ingredient: Divalproex sodium (ABT-711) Individual Study Table Referring to Part of Dossier: Volume: Page: (For National
More informationONCOLOGY: WHEN EXPERTISE, EXPERIENCE AND DATA MATTER. KANTAR HEALTH ONCOLOGY SOLUTIONS: FOCUSED I DEDICATED I HERITAGE
CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES ONCOLOGY: WHEN EXPERTISE, EXPERIENCE AND DATA MATTER. KANTAR HEALTH ONCOLOGY SOLUTIONS: FOCUSED I DEDICATED I HERITAGE AT KANTAR HEALTH, ONCOLOGY
More informationScientific conclusions
Annex II Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency 24 Scientific conclusions Overall
More informationWhat s New MedDRA Version 13.1
What s New MedDRA Version 13.1 Acknowledgements ACKNOWLEDGEMENTS MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Adobe is a registered
More informationDEMOGRAPHICS PHYSICAL ATTRIBUTES VITAL SIGNS. Protocol: ABC-123 SCREENING. Subject ID. Subject Initials. Visit Date: / / [ YYYY/MM/DD]
SCREENING Visit Date: DEMOGRAPHICS / / [YYYY/MM/DD] Consent Signed Date and time / / [YYYY/MM/DD] : Has written assent been obtained? If no, why not? YES NO Gender: Male Female Birthdate: Permission given
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationMeaningful Use - Core Measure 5 Record Smoking Status Configuration Guide
Enterprise EHR Meaningful Use - Core Measure 5 Record Smoking Status Configuration Guide Last Updated: October 26, 2013 Copyright 2013 Allscripts Healthcare, LLC. www.allscripts.com MU Core 5 Record Smoking
More informationNot all NLP is Created Equal:
Not all NLP is Created Equal: CAC Technology Underpinnings that Drive Accuracy, Experience and Overall Revenue Performance Page 1 Performance Perspectives Health care financial leaders and health information
More informationSponsor / Company: Sanofi Drug substance(s): SAR (iniparib)
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationGeorge Cernile Artificial Intelligence in Medicine Toronto, ON. Carol L. Kosary National Cancer Institute Rockville, MD
George Cernile Artificial Intelligence in Medicine Toronto, ON Carol L. Kosary National Cancer Institute Rockville, MD Using RCA A system to convert free text pathology reports into a database of discrete
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationConvolutional Neural Networks for Text Classification
Convolutional Neural Networks for Text Classification Sebastian Sierra MindLab Research Group July 1, 2016 ebastian Sierra (MindLab Research Group) NLP Summer Class July 1, 2016 1 / 32 Outline 1 What is
More informationPFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.
Public Disclosure Synopsis Protocol A7772 September 25 Final PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.
More informationSynopsis Style Clinical Study Report SR EFC10139 Version number: 1 (electronic 2.0)
SYNOPSIS Title of the study: A randomized, double-blind, parallel-group, multicenter, multinational study to assess the long-term effect, over 1 year, of rimonabant 10 mg in comparison with rimonabant
More informationProposed MedDRA Version 17.0 Complex Changes (July 2013)
Proposed MedDRA Version 17.0 Complex Changes (July 2013) MedDRA User Submitted Requests: 1. Add a new HLT Exserohilum infections to HLGT Fungal infectious disorders Submitter rationale: Adding this HLT
More information2.0 Synopsis. Adalimumab M Clinical Study Report R&D/04/900. (For National Authority Use Only) Referring to Part of Dossier: Volume:
2. Synopsis Abbott Laboratories Name of Study Drug: Name of Active Ingredient: Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Phase
More informationSession 35: Text Analytics: You Need More than NLP. Eric Just Senior Vice President Health Catalyst
Session 35: Text Analytics: You Need More than NLP Eric Just Senior Vice President Health Catalyst Learning Objectives Why text search is an important part of clinical text analytics The fundamentals of
More informationWhat s New MedDRA Version March
C What s New MedDRA Version 21.0 Acknowledgements ACKNOWLEDGEMENTS MedDRA trademark is registered by IFPMA on behalf of ICH. Disclaimer and Copyright Notice This document is protected by copyright and
More informationNow Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
A service of the U.S. National Institutes of Health Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting Trial record 1 of 1 for: Keynote 355 Previous Study Return to List
More informationUsing Natural Language Processing To Analyze Electronic Health Records. Philip Poon PhD Data Scientist
Using Natural Language Processing To Analyze Electronic Health Records Philip Poon PhD Data Scientist Agenda Overview of UnityPoint Health and Electronic Health Record Natural Language Processing development
More informationSafety Assessment in Clinical Trials and Beyond
Safety Assessment in Clinical Trials and Beyond Yuliya Yasinskaya, MD Medical Team Leader Division of Anti-Infective Products Center for Drug Evaluation and Research FDA Clinical Investigator Training
More informationRegulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help.
Regulatory Support for Tobacco Products Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. PREMARKET TOBACCO (PMTA) HUMAN FACTORS STUDIES SUBSTANTIAL EQUIVALENCE
More informationCommon Errors. ClinicalTrials.gov Basic Results Database
Common Errors ClinicalTrials.gov Basic Results Database 1 Principles for Using the Basic Results Database Submitted data are used to develop basic tables for the public display Tables must be interpretable
More informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationValidating and Grouping Diagnosis
Validating and Grouping Diagnosis DataSci Consulting CMS SAS User Group Conference, 2007 Grouping Grouping Grouping Goals Cover basic concepts about diagnoses and codes Share some examples Provide useful,
More informationMARS Ambulatory ECG Analysis The power to assess and predict
GE Healthcare MARS Ambulatory ECG Analysis The power to assess and predict Connecting hearts and minds Prevention starts with knowledge Around the world, heart disease is one of our fastest-growing health
More informationNEXAVAR (sorafenib tosylate) oral tablet
NEXAVAR (sorafenib tosylate) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy
More informationNGS IN ONCOLOGY: FDA S PERSPECTIVE
NGS IN ONCOLOGY: FDA S PERSPECTIVE ASQ Biomed/Biotech SIG Event April 26, 2018 Gaithersburg, MD You Li, Ph.D. Division of Molecular Genetics and Pathology Food and Drug Administration (FDA) Center for
More informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationSYNOPSIS. Clinical Study Report IM Double-blind Period
Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier SYNOPSIS (For National Authority
More informationEvaluation of Clinical Text Segmentation to Facilitate Cohort Retrieval
Evaluation of Clinical Text Segmentation to Facilitate Cohort Retrieval Enhanced Cohort Identification and Retrieval S105 Tracy Edinger, ND, MS Oregon Health & Science University Twitter: #AMIA2017 Co-Authors
More informationAutomatic extraction of adverse drug reaction terms from medical free text
Automatic extraction of adverse drug reaction terms from medical free text Ola Caster Uppsala Monitoring Centre WHO Collaborating Centre for International Drug Monitoring ISCB 2009, Prague, Czech Republic
More informationA Study of Abbreviations in Clinical Notes Hua Xu MS, MA 1, Peter D. Stetson, MD, MA 1, 2, Carol Friedman Ph.D. 1
A Study of Abbreviations in Clinical Notes Hua Xu MS, MA 1, Peter D. Stetson, MD, MA 1, 2, Carol Friedman Ph.D. 1 1 Department of Biomedical Informatics, Columbia University, New York, NY, USA 2 Department
More informationSearch for studies: ClinicalTrials.gov Identifier: NCT
ClinicalTrials.gov A service of the U.S. National Institutes of Health Search for studies: Example. "Heart attack" AND "Los Angeles" Advanced Search Help Studies by Topic Glossary Find Studies About Clinical
More informationCochrane Breast Cancer Group
Cochrane Breast Cancer Group Version and date: V3.2, September 2013 Intervention Cochrane Protocol checklist for authors This checklist is designed to help you (the authors) complete your Cochrane Protocol.
More informationA Simple Pipeline Application for Identifying and Negating SNOMED CT in Free Text
A Simple Pipeline Application for Identifying and Negating SNOMED CT in Free Text Anthony Nguyen 1, Michael Lawley 1, David Hansen 1, Shoni Colquist 2 1 The Australian e-health Research Centre, CSIRO ICT
More informationLow-dose AZA, Pioglitazone, ATRA Versus Standard-dose AZA in Patients >=60 Years With Refractory AML (AML-ViVA)
We updated the design of this site on December 18, 2017. Learn more. Find Studies About Studies Submit Studies Resources About Site Trial record 1 of 1 for: AMLSG26-16/AML-ViVA Previous Study Return to
More informationAVENIO family of NGS oncology assays ctdna and Tumor Tissue Analysis Kits
AVENIO family of NGS oncology assays ctdna and Tumor Tissue Analysis Kits Accelerating clinical research Next-generation sequencing (NGS) has the ability to interrogate many different genes and detect
More informationCetirizine Proposed Core Safety Profile
Cetirizine Proposed Core Safety Profile Posology and method of administration Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function
More informationSafety profile of Liraglutide: Recent Updates. Mohammadreza Rostamzadeh,M.D.
Safety profile of Liraglutide: Recent Updates Mohammadreza Rostamzadeh,M.D. Pancreatitis: Victoza post-marketing experience: spontaneous reports of pancreatitis For the majority of the cases, there is
More informationDetecting Patient Complexity from Free Text Notes Using a Hybrid AI Approach
Detecting Patient Complexity from Free Text Notes Using a Hybrid AI Approach Malcolm Pradhan, CMO MBBS, PhD, FACHI Daniel Padilla, ML Engineer BEng,, PhD Alcidion Corporation Overview Alcidion s Natural
More informationEMBASE Find quick, relevant answers to your biomedical questions
EMBASE Find quick, relevant answers to your biomedical questions Piotr Golkiewicz Solution Sales Manager Life Sciences Central and Eastern Europe and Russia Embase is a registered trademark of Elsevier
More informationChapter 12 Conclusions and Outlook
Chapter 12 Conclusions and Outlook In this book research in clinical text mining from the early days in 1970 up to now (2017) has been compiled. This book provided information on paper based patient record
More informationGlobal Harmonization Task Force SG3 Comments and Recommendations ISO/DIS 9001: 2000 and ISO/DIS 9000: 2000 And Revision of ISO and 13488
Page 1 of 6 Global Harmonization Task Force SG3 ISO/DIS 9001: 2000 and ISO/DIS 9000: 2000 And Revision of ISO 13485 and 13488 GENERAL COMMENTS The Global Harmonization Task Force Study Group Three (GHTF
More informationNGS ONCOPANELS: FDA S PERSPECTIVE
NGS ONCOPANELS: FDA S PERSPECTIVE CBA Workshop: Biomarker and Application in Drug Development August 11, 2018 Rockville, MD You Li, Ph.D. Division of Molecular Genetics and Pathology Food and Drug Administration
More informationPROGRAMMER S SAFETY KIT: Important Points to Remember While Programming or Validating Safety Tables
PharmaSUG 2012 - Paper IB09 PROGRAMMER S SAFETY KIT: Important Points to Remember While Programming or Validating Safety Tables Sneha Sarmukadam, Statistical Programmer, PharmaNet/i3, Pune, India Sandeep
More informationClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013. ClinicalTrials.gov ID: NCT
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013 ClinicalTrials.gov ID: NCT00168454 Study Identification Unique Protocol ID: 191622-077 Brief Title: A
More informationKnowledge networks of biological and medical data An exhaustive and flexible solution to model life sciences domains
Knowledge networks of biological and medical data An exhaustive and flexible solution to model life sciences domains Dr. Sascha Losko, Dr. Karsten Wenger, Dr. Wenzel Kalus, Dr. Andrea Ramge, Dr. Jens Wiehler,
More informationPatient Group Direction for the Supply of Varenicline (Champix ) by Authorised Community Pharmacists
Patient Group Direction for the Supply of Varenicline (Champix ) This Patient Group Direction (PGD) is a specific written instruction for the supply of varenicline to groups of patients who may not be
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationAdverse Events Monitoring (aka Pharmacovigilance)
Adverse Events Monitoring (aka Pharmacovigilance) Presentation to American Conference Institute s FDA Boot Camp William W. Vodra May 16, 2007 Agenda What is pharmacovigilance (PV)? How does PV use adverse
More informationPsychology Perception
Psychology 343 - Perception James R. Sawusch, 360 Park Hall jsawusch@buffalo.edu 645-0238 TA is Timothy Pruitt, 312 Park tapruitt@buffalo.edu Text is Sensation & Perception by Goldstein (8th edition) PSY
More informationClinical NLP, PubGene Clinical trials in Coremine Oncology Text processing and information extraction for surgery planning form
Clinical NLP, PubGene Clinical trials in Coremine Oncology Text processing and information extraction for surgery planning form November 2017 Dag Are Steenhoff Hov, PubGene AS 1 PubGene, founded 2001 ArrayIt
More informationIntervention ML: Mapping of Meal data. Rahul Loharkar, inventiv Health Clinical, Pune, India Sandeep Sawant, inventiv Health Clinical, Mumbai, India
Paper DS06 Intervention ML: Mapping of Meal data. Rahul Loharkar, inventiv Health Clinical, Pune, India Sandeep Sawant, inventiv Health Clinical, Mumbai, India ABSTRACT The focus of most bioavailability/bioequivalence
More informationErasmus MC at CLEF ehealth 2016: Concept Recognition and Coding in French Texts
Erasmus MC at CLEF ehealth 2016: Concept Recognition and Coding in French Texts Erik M. van Mulligen, Zubair Afzal, Saber A. Akhondi, Dang Vo, and Jan A. Kors Department of Medical Informatics, Erasmus
More informationKnowledge Discovery and Data Mining. Testing. Performance Measures. Notes. Lecture 15 - ROC, AUC & Lift. Tom Kelsey. Notes
Knowledge Discovery and Data Mining Lecture 15 - ROC, AUC & Lift Tom Kelsey School of Computer Science University of St Andrews http://tom.home.cs.st-andrews.ac.uk twk@st-andrews.ac.uk Tom Kelsey ID5059-17-AUC
More informationIn all of these roles, I've used healthcare data to drive strategy for the life sciences industry.
Intro: When you take a magnifying glass and look at a picture, you see that it's made up of thousands of dots and when you pull back, those dots become the details that create the picture. There's real
More informationBellagio, Las Vegas November 26-28, Patricia Davis Computer-assisted Coding Blazing a Trail to ICD 10
Bellagio, Las Vegas November 26-28, 2012 Patricia Davis Computer-assisted Coding Blazing a Trail to ICD 10 2 Publisher s Notice Although we have tried to include accurate and comprehensive information
More informationicommunicator, Leading Speech-to-Text-To-Sign Language Software System, Announces Version 5.0
For Immediate Release: William G. Daddi Daddi Brand Communications (P) 212-404-6619 (M) 917-620-3717 Bill@daddibrand.com icommunicator, Leading Speech-to-Text-To-Sign Language Software System, Announces
More informationFull Novartis CTRD Results Template
Full Novartis CTRD Results Template Sponsor Novartis Generic Drug Name vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Protocol Number CLAF237A23137E1 Title A
More informationAdapting Your Risk Adjustment Program to HCC Model V.22
Adapting Your Risk Adjustment Program to HCC Model V.22 November 16, 2015 Presented by: Kim Browning, CHRS, PMP, CHC Executive Vice President Learning Objectives Transitioning from Blended to Single Model
More informationExtraction of Adverse Drug Effects from Clinical Records
MEDINFO 2010 C. Safran et al. (Eds.) IOS Press, 2010 2010 IMIA and SAHIA. All rights reserved. doi:10.3233/978-1-60750-588-4-739 739 Extraction of Adverse Drug Effects from Clinical Records Eiji Aramaki
More informationSponsor Novartis. Generic Drug Name Pasireotide. Therapeutic Area of Trial Cushing s disease. Protocol Number CSOM230B2208E1
Sponsor Novartis Generic Drug Name Pasireotide Therapeutic Area of Trial Cushing s disease Protocol Number CSOM230B2208E1 Title Extension to a multicenter, open-label study to assess the safety and efficacy
More informationCritical Illness Claim - Doctor s Statement Blindness (Loss of Sight) / Optic Nerve Atrophy with Low Vision
*SUPDOC* Critical Illness Claim - Doctor s Statement Blindness (Loss of Sight) / Optic Nerve Atrophy with Low Vision SECTION 2 DOCTOR S STATEMENT (to be completed by the attending doctor at claimant s
More informationALL PRINCIPAL INVESTIGATORS/NURSES/DATA MANAGERS RE: PROTOCOL GOG-0233 ACRIN 6671, REVISION # 9 & #10
TO: FROM: ALL PRINCIPAL INVESTIGATORS/NURSES/DATA MANAGERS LEAH MADDEN PROTOCOL SECTION DATE: JUNE 27, 2011 RE: PROTOCOL GOG-0233 ACRIN 6671, REVISION # 9 & #10 Protocol Title: Utility of Preoperative
More informationComputational Neuroscience. Instructor: Odelia Schwartz
Computational Neuroscience 2017 1 Instructor: Odelia Schwartz From the NIH web site: Committee report: Brain 2025: A Scientific Vision (from 2014) #1. Discovering diversity: Identify and provide experimental
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationSponsor Novartis. Generic Drug Name Vildagliptin/Metformin. Therapeutic Area of Trial Type 2 diabetes. Approved Indication Type 2 diabetes
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin/Metformin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLMF237A2309
More informationSemantic Alignment between ICD-11 and SNOMED-CT. By Marcie Wright RHIA, CHDA, CCS
Semantic Alignment between ICD-11 and SNOMED-CT By Marcie Wright RHIA, CHDA, CCS World Health Organization (WHO) owns and publishes the International Classification of Diseases (ICD) WHO was entrusted
More informationA proposed bridging approach for the assessment of novel tobacco products
A proposed bridging approach for the assessment of novel tobacco products Dr. Ian M. Fearon British American Tobacco (Investments) Limited R&D Centre Southampton, U.K. Agenda Insight into BAT R&D Evolution
More informationMyDispense OTC exercise Guide
MyDispense OTC exercise Guide Version 5.0 Page 1 of 23 Page 2 of 23 Table of Contents What is MyDispense?... 4 Who is this guide for?... 4 How should I use this guide?... 4 OTC exercises explained... 4
More informationDeaf Awareness mini-presentation
Welcome Deaf Awareness mini-presentation Presentation by Victoria Lessing September 2016 Programme Difference between hearing-impaired & Deaf (based from medical and cultural perspectives) An overview
More informationGENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):
Make copies of the blank SAE report form as needed. Retain originals with confirmation of all information faxed to DMID Pharmacovigilance Group Clinical Research Operations and Management Support (CROMS
More informationPhase 3 investigation of aprocitentan for resistant hypertension management. Investor Webcast June 2018
Phase 3 investigation of aprocitentan for resistant hypertension management Investor Webcast June 2018 The following information contains certain forward-looking statements, relating to the company s business,
More informationStandards for reporting Plain Language Summaries (PLS) for Cochrane Diagnostic Test Accuracy Reviews (interim guidance adapted from Methodological
s for reporting Plain Language Summaries (PLS) for Cochrane Diagnostic Test Accuracy Reviews (interim guidance adapted from Methodological Expectations of Cochrane Intervention Reviews (MECIR) guidance
More informationAdverse Event Terminology and Coding Working Group
Adverse Event Terminology and Coding Working Group March 2018 Working Group Chair: H. Ishikawa Office of Standards and Guidelines Development Pharmaceuticals and Medical Devices Agency Overview of IMDRF
More informationStudy 2 ( ) Pivotal Phase 3 Study Top-Line Results. October 29, 2018
Study 2 (1002-047) Pivotal Phase 3 Study Top-Line Results October 29, 2018 Safe Harbor Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements
More informationVI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology VI.2.2 Summary of treatment benefits
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nausea and vomiting are common ailments had by many individuals. Nausea is defined as the unpleasant, painless sensation that
More informationChantix Label Update 2018
Chantix Label Update 2018 Chantix (varenicline) Prescribing Information Chantix Prescribing Info URL and Disclaimer Please refer to the full Prescribing Information on important treatment considerations
More informationDistraction techniques
Introduction are a form of coping skills enhancement, taught during cognitive behavioural therapy. These techniques are used to distract and draw attention away from the auditory symptoms of schizophrenia,
More informationKeeping Abreast of Breast Imagers: Radiology Pathology Correlation for the Rest of Us
SIIM 2016 Scientific Session Quality and Safety Part 1 Thursday, June 30 8:00 am 9:30 am Keeping Abreast of Breast Imagers: Radiology Pathology Correlation for the Rest of Us Linda C. Kelahan, MD, Medstar
More informationMedDRA Coding Quality: How to Avoid Common Pitfalls
MedDRA Coding Quality: How to Avoid Common Pitfalls Patricia Mozzicato, MD Chief Medical Officer MedDRA MSSO Disclaimer The views and opinions expressed in the following PowerPoint slides are those of
More information2) Cases and controls were genotyped on different platforms. The comparability of the platforms should be discussed.
Reviewers' Comments: Reviewer #1 (Remarks to the Author) The manuscript titled 'Association of variations in HLA-class II and other loci with susceptibility to lung adenocarcinoma with EGFR mutation' evaluated
More informationReal Time Sign Language Processing System
Real Time Sign Language Processing System Dibyabiva Seth (&), Anindita Ghosh, Ariruna Dasgupta, and Asoke Nath Department of Computer Science, St. Xavier s College (Autonomous), Kolkata, India meetdseth@gmail.com,
More informationAutomatic generation of MedDRA terms groupings using an ontology
Automatic generation of MedDRA terms groupings using an ontology Gunnar DECLERCK a,1, Cédric BOUSQUET a,b and Marie-Christine JAULENT a a INSERM, UMRS 872 EQ20, Université Paris Descartes, France. b Department
More informationSupplementary Figure 1
Supplementary Figure 1 An example of the gene-term-disease network automatically generated by Phenolyzer web server for 'autism'. The largest word represents the user s input term, Autism. The pink round
More informationHacettepe University Department of Computer Science & Engineering
Subject Hacettepe University Department of Computer Science & Engineering Submission Date : 29 May 2013 Deadline : 12 Jun 2013 Language/version Advisor BBM 204 SOFTWARE LABORATORY II EXPERIMENT 5 for section
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationGoal of site data management 12/2/2009. Ultimate goal: reliable and valid clinical trial to improve health
RC-4 Overview of Clinical Site Operations and Management Unit 4: Overview of Data Quality and Monitoring Principal Investigators Lynda Wilson, PhD, RN Marti Rice, PhD, RN Program Manager TBA Course Instructors:
More informationClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT)
ClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT) January 9, 2009 * Required by ClinicalTrials.gov [*] Conditionally required by ClinicalTrials.gov (FDAAA) May be required to comply with
More informationBig Data & Predictive Analytics Case Studies: Applying data science to human data Big-Data.AI Summit
Big Data & Predictive Analytics Case Studies: Applying data science to human data 1.03.2018 Big-Data.AI Summit Dr. Arnim Jost, Commercial Director Technology Copyright 2017 IQVIA. All rights reserved.
More informationISV RANDOMIZED CLINICAL TRIAL PUBLIC USE DATASET
ABOUT THE STUDY The NHLBI Infant Single Ventricle (ISV) randomized double-blind placebo-controlled trial was conducted by the Pediatric Heart Network (PHN) at 10 centers in the United States and Canada,
More information