Sentinel is committed to publishing findings in journals and sharing information at relevant conferences. The following table provides summary information about Sentinel activities that have appeared in peer-reviewed journals or conference materials.
Publications and Presentations
Title |
Authors | Date Posted |
|---|---|---|
| A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data |
Ryan Carnahan, PharmD, MS, BCPP, Ronald Herman, PhD, Kevin G. Moores, PharmD |
02/05/2012 |
| A Systematic Review of Validated Methods for Identifying Transverse Myelitis using Administrative or Claims Data |
S. Elizabeth Williams MD; Ryan Carnahan PharmD, MS, BCPP; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH |
12/30/2013 |
| A Systematic Review of Validated Methods for Identifying Uveitis using Administrative or Claims Data |
S. Elizabeth Williams MD; Ryan Carnahan PharmD, MS, BCPP; Melissa L. McPheeters PhD, MPH |
12/30/2013 |
| A Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims Data |
Leo Tamariz MD, MPH; Thomas Harkins MA, MPH; Vinit Nair BPharm, MS, RPh |
01/19/2012 |
| A Systematic Review of Validated Methods for Identifying Ventricular Arrhythmias using Administrative and Claims Data |
Leo Tamariz MD; Thomas Harkins MA, MPH; Vinit Nair BPharm, MS, RPh |
01/19/2012 |
| A Systematic Review of Validated Methods to Capture Acute Bronchospasm using Administrative or Claims Data |
Mona Sharifi MD, MPH; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH |
12/30/2013 |
| A Systematic Review of Validated Methods to Capture Myopericarditis using Administrative or Claims Data |
Rachel T. Idowu MD; Ryan Carnahan PharmD, MS, BCPP; Nila Sathe MA, MLIS; Melissa L. McPheeters PhD, MPH |
12/30/2013 |
| A Systematic Review of Validated Methods to Capture Several Rare Conditions using Administrative or Claims Data |
Christopher D. Lee MD, MPH; S. Elizabeth Williams MD; Nila A. Sathe MA, MLIS; Melissa L. McPheeters PhD, MPH |
12/30/2013 |
| A Systematic Review of Validated Methods to Capture Stillbirth and Spontaneous Abortion using Administrative or Claims Data |
Frances E. Likis DrPH, NP, CNM; Nila Sathe MA, MLIS; Ryan Carnahan PharmD, MS, BCPP; Melissa McPheeters PhD, MPH |
12/30/2013 |
| A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program |
Meghan A. Baker MD, ScD; Tracy A. Lieu MD, MPH; Lingling Li PhD; Wei Hua MD; Yandong Qiang MD, PhD, MPH; Alison Tse Kawai ScD; Bruce Fireman MA; David B. Martin MD, MPH; Michael Nguyen MD |
03/13/2015 |
| Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011 |
Allison L. Naleway PhD; Brad Cranea; Ning Smith; Matthew F. Daley MD; James Donahue; Julianne Gee Sharon K. Greene PhD, MPH; Theresa Harrington; Lisa A. Jackson MD, MPH; Nicola P. Klein MD, PhD; Hung Fu Tseng; Claudia Vellozzi MD; Eric S. Weintraub
|
01/02/2016 |
| Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics |
Marsha Raebel PharmD; Robert Penfold PhD; Ann McMahon MD, MSc; Marsha Reichman PhD; Susan Shetterly MS; Glenn Goodrich MS; Susan Andrade ScD; Christoph Correll MD; Tobias Gerhard PhD |
10/06/2014 |
| Antiemetic use among Pregnant Women in the United States: the Escalating use of Ondansetron |
Lockwood G. Taylor PhD, MPH; Steven T. Bird PharmD, PhD, MS; Leyla Sahin MD; Melissa S. Tassinari PhD; Patty Greene PharmD; Marsha E. Reichman PhD; Susan E. Andrade ScD; Katherine Haffenreffer BS; Sengwee Toh ScD |
02/20/2017 |
| Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population |
Lockwood G. Taylor, Genna Panucci, Andrew D. Mosholder, Sengwee Toh, Ting-Ying Huang |
06/04/2019 |
| Applying Sequential Surveillance Methods That Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Setting: Part 2 In-Depth Example of a Re-Analysis of the MMRV Combination Vaccine and Seizure Risk |
Andrea J. Cook, Robert D. Wellman, Tracey Marsh, Azadeh Shoaibi, Ram C. Tiwari, Michael Nguyen, Denise Boudreau, Eric S. Weintraub, Lisa Jackson, Jennifer C. Nelson |
05/02/2019 |
| Assessing the Impact of the New ICD‐10‐CM Coding System on Pharmacoepidemiologic Studies — An Application to the Known Association Between Angiotensin‐Converting Enzyme Inhibitors and Angioedema |
Catherine A. Panozzo, Emily C. Welch, Tiffany S. Woodworth, Ting‐Ying Huang, Qoua L. Her, Joshua J. Gagne, Jenny W. Sun, Catherine Rogers, Talia J. Menzin, Max Ehrmann, Katherine E. Freitas, Nicole R. Haug, Sengwee Toh |
06/26/2018 |
| Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System |
Noelle M. Cocoros, Marc R. Larochelle, Jennifer Popovic, Andrew B. Petrone, Cynthia Kornegay, Jing Ju, Judith A. Racoosin |
10/31/2018 |
| Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System |
W. Katherine Yih PhD, MPH; Judith C. Maro PhD; Michael Nguyen MD; Meghan A. Baker MD, ScD; Carolyn Balsbaugh MPH; David V. Cole BM; Inna Dashevsky MS; Adamma Mba-Jonas MD; Martin Kulldorff PhD |
02/22/2018 |
| Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database |
Jie Li, Genna Panucci, David Moeny, Wei Liu, Judith C. Maro, Sengwee Toh, Ting-Ying Huang |
10/01/2018 |
| Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference |
Rima Izem PhD |
01/12/2018 |
| CDER Conversation: The FDA’s Sentinel Initiative | 11/27/2017 | |
| Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data |
Jennifer C. Nelson PhD; Andrea J. Cook PhD; Onchee Yu MS; Clara Dominguez; Shanshan Zhao; Sharon K. Greene PhD, MPH; Bruce H. Fireman MA; Steven J. Jacobsen; Eric S. Weintraub; Lisa A. Jackson MD, MPH |
01/19/2012 |
| Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011 |
Melissa G. Butler PharmD, PhD, MPH; Esther H. Zhou MD, PhD; Fang Zhang PhD; Yu-te Wu PhD; Ann Chen Wu MD, MPH; Mark S. Levenson PhD; Pingsheng Wu PhD; Sally Seymour MD; Sengwee Toh ScD; Aarthi Iyer MPH; Solomon Iyasu MD, MPH; Meghan A. Baker MD, ScD |
03/01/2016 |
| Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems |
Carlos Bell MPH; Aloka Chakravarty PhD; Susan Gruber PhD, MPH, MS; Susan R. Heckbert; Mark Levenson; David Martin MD; Jennifer C. Nelson PhD; Simone Pinheiro ScD; Bruce M. Psaty MD, PhD; Christian G. Reich MD, PhD; Sebastian Schneeweiss MD, ScD; Azadeh Shoaibi PhD, MS, MHS; Sengwee Toh ScD; Alexander M. Walker MD, PhD |
09/28/2014 |
| Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Acute Myocardial Infarction (AMI) Among Intravenous Immune Globulin (IGIV) Users in the Sentinel Distributed Database | 02/15/2018 | |
| Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database |
Eric M. Ammann MS; Enrique C. Leira MD, MS; Scott K. Winiecki MD; Nandakumar Nagaraja MD, MS; Sudeepta Dandapat MD; Ryan M. Carnahan PharmD, MS, BCPP; Marin L. Schweizer PhD; James C. Torner PhD; Candace C. Fuller PhD; Charles E. Leonard PharmD, MSCE; Crystal Garcia MPH; Madelyn Pimentel; Elizabeth A. Chrischilles PhD, MS |
12/01/2017 |
| Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database |
Eric M. Ammann, Adam Cuker, Ryan M. Carnahan, Usha S. Perepu, Scott K. Winiecki, Marin L. Schweizer, Charles E. Leonard, Candace C. Fuller, Crystal Garcia, Cole Haskins, Elizabeth A. Chrischilles |
02/23/2018 |
| Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance |
Zachary Wyner, Juliane Reynolds, Chayim Herzig-Marx, Shyam Deval, Adam Rauch, Jeffrey Brown, David Martin |
11/05/2018 |
| Comparative Risk for Angioedema Associated with the Use of Drugs that Target the Renin-Angiotensin-Aldosterone System |
Sengwee Toh ScD; Marsha E. Reichman PhD; Monika Houstoun PharmD; Mary Ross Southworth PharmD; Xiao Ding PhD; Adrian F. Hernandez MD; Mark Levenson PhD; Lingling Li PhD; Carolyn McCloskey MD, MPH; Azadeh Shoaibi MS, MHS; Eileen Wu PharmD; Gwen Zornberg MD, MS, ScD; Sean Hennessy PharmD, PhD |
11/12/2012 |
| Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin |
Scott K. Winiecki MD; Bethany Baer MD; Wambui Chege MD; Christopher Jankosky MD; Paul D. Mintz MD; Meghan A. Baker MD, ScD; Tiffany S. Woodworth MPH; Michael D. Nguyen MD |
07/14/2015 |
| Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance |
Ivair R. Silva PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA and Department of Statistics, Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil Martin Kulldorff PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA |
05/22/2015 |
| Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks |
Jessica M. Malenfant, Jenny Hochstadt, Bridget Nolan, Kimberly Barrett, Dean Corriveau, Daniel Dee, Marcelline Harris, Chayim Herzig‐Marx, Vinit P. Nair, Zachary Wyner, Jeffrey S. Brown |
02/14/2019 |
| Data Enclaves for Sharing Information Derived From Clinical and Administrative Data |
Richard Platt and Tracy Lieu |
08/06/2018 |
| Data Extraction and Management in Networks of Observational Health Care Databases for Scientific Research: A Comparison of EU-ADR, OMOP, Mini-Sentinel and MATRICE Strategies |
Rosa Gini PhD; Martijn Schuemie PhD; Jeffrey Brown PhD; Patrick Ryan PhD; Edoardo Vacchi PhD; Massimo Coppola; Walter Cazzola PhD; Preciosa Coloma MD, PhD; Roberto Berni; Gayo Diallo PhD; José Luis Oliveira PhD; Paul Avillach MD, PhD; Gianluca Trifirò MD, PhD; Peter Rijnbeek PhD, MSc; Mariadonata Bellentani; Johan van Der Lei MD, PhD; Niek Klazinga MD, PhD; Miriam Sturkenboom PhD, MS |
02/08/2016 |
| Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic |
Shirley V. Wang, Judith C. Maro, Elande Baro, Rima Izem, Inna Dashevsky, James R. Rogers, Michael Nguyen, Joshua J. Gagne, Elisabetta Patorno, Krista F. Huybrechts, Jacqueline M. Major, Esther Zhou, Megan Reidy, Austin Cosgrove, Sebastian Schneeweiss, Martin Kulldorff |
08/01/2018 |
| Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association |
Susan Gruber PhD, MPH; Aloka Chakravarty PhD; Susan R. Heckbert MD, PhD; Mark S. Levenson PhD; David Martin MD, MPH; Jennifer C. Nelson PhD; Bruce M. Psaty MD, PhD; Simone Pinheiro ScD, MSc; Christian G. Reich MD, PhD; Sengwee Toh ScD; Alexander M. Walker MD, PhD |
07/14/2016 |
| Design Considerations in an Active Medical Product Safety Monitoring System |
Joshua J. Gagne PharmD, ScD; Bruce Fireman, MA; Patrick B. Ryan PhD; Malcolm Maclure SM, SD; Tobias Gerhard PhD; Sengwee Toh ScD; Jeremy A. Rassen ScD; Jennifer C. Nelson PhD; Sebastian Schneeweiss MD, ScD |
01/19/2012 |
| Design Considerations, Architecture, and use of the Mini-Sentinel Distributed Data System |
Jeffrey S. Brown PhD; Lesley H. Curtis PhD; Mark G. Weiner MD; Denise M. Boudreau RPh, PhD; William O. Cooper MD, MPH; Gregory W. Daniel PhD, MPH; Vinit P. Nair BPharm, MS, RPh; Marsha A. Raebel PharmD; Nicolas U. Beaulieu MA; Robert Rosofsky MA; Tiffany S. Woodworth MPH |
02/05/2012 |
| Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel |
Sarah L. Cutrona MD, MPH; Sengwee Toh ScD; Aarthi Iyer MPH; Sarah Foy BA; Elizabeth Cavagnaro MPH; Susan Forrow BA; Judith A. Racoosin MD, MPH; Robert Goldberg PhD; Jerry H. Gurwitz MD |
01/19/2012 |
| Developing the Sentinel System — A National Resource for Evidence Development |
Rachel E. Behrman MD, MPH; Joshua S. Benner PharmD, ScD; Jeffrey S. Brown PhD; Mark McClellan MD, PhD; Janet Woodcock MD; Richard Platt MD, MSc |
02/10/2011 |
| Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network |
John G. Connolly SM; Shirley V. Wang PhD, ScM; Candace C. Fuller PhD; Sengwee Toh ScD; Catherine A. Panozzo PhD; Noelle Cocoros DSc; Meijia Zhou MHS; Joshua J. Gagne PharmD, ScD; Judith C. Maro PhD, MS |
10/06/2017 |
| Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data |
Lisa J. Herrinton, Tiffany S. Woodworth, Efe Eworuke, Laura B. Amsden, Liyan Liu, Jo Wyeth, Andrew Petrone, Talia J. Menzin, James Williams, Robert Goldfien, Michael Nguyen |
08/13/2019 |
| Diagnosis‐Based Cohort Augmentation using Laboratory Results Data: The Case of Chronic Kidney Disease |
David Smith, Susan Shetterly, James Flory, Kevin Haynes, Christine Lu, Joshua Gagne, Lisa Herrinton, Carsie Nyirenda, Elisabetta Patorno, Azadeh Shoaibi, Marsha Raebel |
06/22/2018 |
| Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review |
Hassan Fouayzi, Kathryn Anzuoni, Leah Goldman, Jea Young Min, Marie Griffin, Carlos G. Grijalva, James A. Morrow, Christine C. Whitmore, Charles E. Leonard, Mano Selvan, Vinit Nair, Yunping Zhou, Sengwee Toh, Andrew Petrone, James Williams, Elnara Fazio-Eynullayeva, Richard Swain, D. Tyler Coyle, Susan Andrade |
11/23/2018 |
| Distributed Data Networks: A Blueprint for Big Data Sharing and Healthcare Analytics |
Jennifer R. Popovic DVM, MA |
11/18/2016 |
| Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App |
David Martin |
11/30/2018 |
| Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel |
Danijela Stojanovic |
11/30/2018 |
| Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10 |
Elizabeth Suarez |
11/30/2018 |
| Drug Safety in Pregnancy in a Large, Multisite Database: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System |
Susan Andrade |
11/30/2018 |
| Early Impact of the ICD‐10‐CM Transition on Selected Health Outcomes in 13 Electronic Health Care Databases in the United States |
Catherine A. Panozzo, Tiffany S. Woodworth, Emily C. Welch, Ting‐Ying Huang, Qoua L. Her, Kevin Haynes, Catherine Rogers, Talia J. Menzin, Max Ehrmann, Katherine E. Freitas, Nicole R. Haug, Sengwee Toh |
06/26/2018 |
| Effects of Adjusting for Instrumental Variables on Bias and Precision of Effect Estimates |
Jessica A. Myers PhD, ScD; Jeremy A. Rassen ScD; Joshua J. Gagne PharmD, MS; Krista F. Huybrechts PhD, MS; Sebastian Schneeweiss MD, ScD; Kenneth J. Rothman MPH, DrPH; Marshall M. Joffe MD, PhD, MPH; Robert J. Glynn PhD, ScD |
06/08/2011 |
| Electronic Clinical Laboratory Test Results Data Tables: Lessons from Mini-Sentinel |
Marsha A. Raebel PharmD; Kevin Haynes PharmD, MSCE; Tiffany S. Woodworth MPH; Gwyn Saylor; Elizabeth Cavagnaro MPH; Kara O. Coughlin; Lesley H. Curtis PhD; Mark G. Weiner MD; Patrick Archdeacon MD; Jeffrey S. Brown PhD |
02/18/2014 |
| Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies |
Steven T. Bird PharmD, PhD, MS; Kate Gelperin MD; Lockwood Taylor PhD, MPH; Leyla Sahin MD; Hoda Hammad MS, MPH; Susan E. Andrade ScD; Mohamed A. Mohamoud PharmD, MPH; Sengwee Toh, ScD; Christian Hampp PhD |
08/29/2017 |
| Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System |
Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis |
08/28/2018 |
| Evaluating the Use of Bootstrapping in Cohort Studies Conducted with 1:1 Propensity Score Matching — A Plasmode Simulation Study |
Rishi J. Desai, Richard Wyss, Younathan Abdia, Sengwee Toh, Margaret Johnson, Hana Lee, Sara Karami, Jacqueline M. Major, Michael Nguyen, Shirley V. Wang, Jessica M. Franklin, Joshua J. Gagne |
04/24/2019 |
| Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring |
Stanley Xu PhD; Susan Shetterly MS; Andrea J. Cook PhD; Marsha A. Raebel PharmD; Sunali Goonesekera MS; Azadeh Shoaibi PhD, MS, MHS; Jason Roy PhD; Bruce Fireman MA |
02/15/2016 |
| Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs |
Joshua J. Gagne, Jennifer R. Popovic, Michael Nguyen, Sukhminder K. Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B. Petrone, Anita K. Wagner, Sarah K. Dutcher |
08/17/2018 |
| Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females |
W. Katherine Yih PhD, MPH; Sharon K. Greene PhD, MPH; Lauren Zichittella MS; Martin Kulldorff PhD; Meghan A. Baker MD, ScD; Jill L.O. de Jong MD, PhD; Ruth Gil Prieto PhD, MPH, MSc; Marie R. Griffin MD, MPH; Robert Jin MS; Nancy D. Lin ScD; Cheryl McMahill-Walraven PhD, MSW; Megan Reidy MPH; Nandini Selvam; PhD, MPH; Mano Selvan PhD; Michael D. Nguyen MD |
01/02/2016 |
| Evaluation of the US Food and Drug Administration Sentinel Analysis Tools in Confirming Previously Observed Drug-Outcome Associations: The Case of Clindamycin and Clostridium difficile Infection |
Ryan M. Carnahan, Jennifer L. Kuntz, Shirley V. Wang, Candace Fuller, Joshua J. Gagne, Charles E. Leonard, Sean Hennessy, Tamra Meyer, Patrick Archdeacon, Chih‐Ying Chen, Catherine A. Panozzo, Sengwee Toh, Hannah Katcoff, Tiffany Woodworth, Aarthi Iyer, Sophia Axtman, Elizabeth A. Chrischilles |
03/13/2018 |
| Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users |
Ryan M. Carnahan, Joshua J. Gagne, Christian Hampp, Charles E. Leonard, Sengwee Toh, Candace C. Fuller, Sean Hennessy, Laura Hou, Noelle M. Cocoros, Genna Panucci, Tiffany Woodworth, Austin Cosgrove, Aarthi Iyer, Elizabeth A. Chrischilles |
01/19/2019 |
| Evaluation of Use of Technologies to Facilitate Medical Chart Review |
Loreen Straub, Joshua J. Gagne, Judith C. Maro, Michael D. Nguyen, Nicolas Beaulieu, Jeffrey S. Brown, Adee Kennedy, Margaret Johnson, Adam Wright, Li Zhou, Shirley V. Wang |
05/20/2019 |
| Evidence from Real-World Data Sentinel Initiative of U.S. FDA |
Darren Toh |
02/20/2019 |
| Evidence Generation from Healthcare Databases: Recommendations for Managing Change |
Alison Bourke, Andrew Bate PhD; Brian C. Sauer PhD, MS; Jeffrey S. Brown PhD; Gillian C. Hall PhD |
05/17/2016 |
| Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes of Interest- An Empirical Evaluation |
Rishi Desai, Richard Wyss, Yinzhu Jin, Justin Bohn, Sengwee Toh, Austin Cosgrove, Adee Kennedy, Jessica Kim, Clara Kim, Rita Ouellet-Hellstrom, Sara Karami, Jacqueline Major, Aaron Niman, Shirley Wang, Joshua Gagne |
06/26/2018 |
| FDA Voices: The Future of FDA's Electronic Safety Surveillance |
Scott Gottlieb and Gerald Dal Pan |
01/09/2019 |
| FDA-Catalyst - Using FDA's Sentinel Initiative for Large-Scale Pragmatic Randomized Trials: Approach and Lessons Learned During the Planning Phase of the First Trial |
Sean D. Pokorney, Kevin Haynes, Crystal Garcia, Hussein R. Al-Khalidi, Sana M. Al-Khatib, Patrick Archdeacon, Jennifer C. Goldsack, Thomas Harkins, Nancy D. Lin, David Martin, Debbe McCall, Vinit Nair, Lauren Parlett, Robert Temple, Cheryl McMahill-Walraven, Christopher B. Granger, Richard Platt |
11/19/2018 |
| Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine |
Alison Tse Kawai ScD; David Martin MD, MPH; Martin Kulldorff PhD; Lingling Li PhD; David V. Cole BM; Cheryl N. McMahill-Walraven PhD, MSW; Nandini Selvam PhD, MPH; Mano S. Selvan PhD; Grace M. Lee MD, MPH |
09/14/2015 |
| Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network |
Richard Platt MD, MSc; Lesley H. Curtis PhD; Jeffrey S. Brown PhD |
07/01/2014 |
| Framework for Assessment of Positive Results from Signal Refinement |
David L. McClure PhD; Marsha A. Raebel PharmD; W. Katherine Yih PhD, MPH; Azadeh Shoaibi PhD, MHS, MS; Jerald E. Mullersman MD, PhD, MPH; Colin Anderson-Smits MPH; Jason M. Glanz PhD |
01/01/2014 |
| Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative |
Judith C. Maro |
10/19/2018 |
| Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program |
Tracy A. Lieu MD, MPH; Michael D. Nguyen MD; Robert Ball MD, MPH, ScM; David B. Martin MD, MPH |
04/16/2012 |
| How Pharmacoepidemiology Networks Can Manage Distributed Analyses to Improve Replicability and Transparency and Minimize Bias |
Robert W. Platt, Richard Platt, Jeffrey S. Brown, David A. Henry, Olaf H. Klungel, Samy Suissa |
01/15/2019 |
| Improving Therapeutic Effectiveness and Safety through Big Healthcare Data |
Sebastian Schneeweiss MD, ScD |
01/17/2016 |
| Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study |
Andrew D. Mosholder, Lockwood Taylor, Glenn Mannheim, Lisa Ortendahl, Tiffany S. Woodworth, Sengwee Toh |
08/10/2018 |
| International Comparison of Approaches to Common Data Models for Comparative Effectiveness Research |
Jeffrey Brown |
09/12/2018 |
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