The Certainty Framework for Assessing Real‐World Data in Studies of Medical Product Safety and Effectiveness
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Nancy A Dreyer | Wei Zhou | Noelle M Cocoros | Sengwee Toh | Peter Arlett | Chieko Ishiguro | Solomon Iyasu | Miriam Sturkenboom | N. Dreyer | M. Sturkenboom | N. Cocoros | S. Toh | Wei Zhou | S. Iyasu | P. Arlett | Chieko Ishiguro
[1] Sudha R. Raman,et al. Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility , 2020, Pharmacoepidemiology and drug safety.
[2] S. Hernández-Díaz,et al. Using nationally representative survey data for external adjustment of unmeasured confounders: An example using the NHANES data , 2019, Pharmacoepidemiology and drug safety.
[3] Sudha R. Raman,et al. Data linkage in pharmacoepidemiology: A call for rigorous evaluation and reporting , 2019, Pharmacoepidemiology and drug safety.
[4] N. Verlander,et al. Influenza-associated mortality in hospital care: a retrospective cohort study of risk factors and impact of oseltamivir in an English teaching hospital, 2016 to 2017 , 2019, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.
[5] S. de Lusignan,et al. ADVANCE system testing: Can coverage of pertussis vaccination be estimated in European countries using electronic healthcare databases: An example. , 2019, Vaccine.
[6] K. Huybrechts,et al. The International Society for Pharmacoepidemiology's Comments on the Core Recommendations in the Summary of the Heads of Medicines Agencies (HMA) ‐ EMA Joint Big Data Task Force , 2019, Pharmacoepidemiology and drug safety.
[7] K. Ohe,et al. Establishment of the MID‐NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan , 2019, Pharmacoepidemiology and drug safety.
[8] Robert B. Anderson,et al. Lessons on Data Collection and Curation From the NFL Injury Surveillance Program , 2019, Sports health.
[9] Nicolle M Gatto,et al. A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions , 2019, Clinical pharmacology and therapeutics.
[10] K. Haynes. Mortality: The final outcome , 2019, Pharmacoepidemiology and drug safety.
[11] R. Erichsen,et al. Validating registry data on statins prescriptions by blood measurements , 2019, Pharmacoepidemiology and drug safety.
[12] Alison Cave,et al. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe , 2019, Clinical pharmacology and therapeutics.
[13] René De La Pedraja. The Final Outcome , 2019, Energy Politics in Colombia.
[14] David Martin,et al. Evaluating the Use of Nonrandomized Real‐World Data Analyses for Regulatory Decision Making , 2019, Clinical pharmacology and therapeutics.
[15] N. Dreyer,et al. Considerations in characterizing real‐world data relevance and quality for regulatory purposes: A commentary , 2018, Pharmacoepidemiology and drug safety.
[16] Olaf Klungel,et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE) , 2018, British Medical Journal.
[17] C. Fuller,et al. Overall and cause‐specific mortality in the Sentinel system: A power analysis , 2018, Pharmacoepidemiology and drug safety.
[18] Keith Marsolo,et al. Evaluating Foundational Data Quality in the National Patient-Centered Clinical Research Network (PCORnet®) , 2018, EGEMS.
[19] Nancy A. Dreyer,et al. Advancing a Framework for Regulatory Use of Real-World Evidence , 2018, Therapeutic innovation & regulatory science.
[20] Keith Marsolo,et al. A longitudinal analysis of data quality in a large pediatric data research network , 2017, J. Am. Medical Informatics Assoc..
[21] David Madigan,et al. Good practices for real‐world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making , 2017, Pharmacoepidemiology and drug safety.
[22] Olaf Klungel,et al. Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0 , 2017, Pharmacoepidemiology and drug safety.
[23] Lisa M. LaVange,et al. Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data. , 2017, JAMA.
[24] H. Sørensen,et al. Data Resource Profile: The Danish National Prescription Registry , 2016, International journal of epidemiology.
[25] N. Dreyer,et al. The GRACE Checklist: A Validated Assessment Tool for High Quality Observational Studies of Comparative Effectiveness , 2016, Journal of managed care & specialty pharmacy.
[26] James M Robins,et al. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. , 2016, American journal of epidemiology.
[27] Sigrun Alba Johannesdottir Schmidt,et al. The Danish National Patient Registry: a review of content, data quality, and research potential , 2015, Clinical epidemiology.
[28] M. Brookhart,et al. Control Outcomes and Exposures for Improving Internal Validity of Nonrandomized Studies. , 2015, Health services research.
[29] David B Richardson,et al. The Active Comparator, New User Study Design in Pharmacoepidemiology: Historical Foundations and Contemporary Application , 2015, Current Epidemiology Reports.
[30] R. Pazdur,et al. FDA Approval: Blinatumomab , 2015, Clinical Cancer Research.
[31] L. Buie,et al. Blinatumomab , 2015, The Annals of pharmacotherapy.
[32] Patrick B. Ryan,et al. Transparent Reporting of Data Quality in Distributed Data Networks , 2015, EGEMS.
[33] Richard F MacLehose,et al. Good practices for quantitative bias analysis. , 2014, International journal of epidemiology.
[34] Timothy L Lash,et al. Comparison of Bias Analysis Strategies Applied to a Large Data Set , 2014, Epidemiology.
[35] W Katherine Yih,et al. Intussusception risk after rotavirus vaccination in U.S. infants. , 2014, The New England journal of medicine.
[36] Takashi Ando,et al. Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications , 2013, PloS one.
[37] P. Wahl,et al. Validation of a claims‐based diagnostic code for Stevens–Johnson syndrome in a commercially insured population , 2012, Pharmacoepidemiology and drug safety.
[38] Teresa To,et al. Development and use of reporting guidelines for assessing the quality of validation studies of health administrative data. , 2011, Journal of clinical epidemiology.
[39] J. Hallas,et al. The Danish National Prescription Registry , 2011, Scandinavian journal of public health.
[40] Rob Koeling,et al. What does validation of cases in electronic record databases mean? The potential contribution of free text† , 2011, Pharmacoepidemiology and drug safety.
[41] Sebastian Schneeweiss,et al. Identification of hospitalizations for intentional self‐harm when E‐codes are incompletely recorded , 2010, Pharmacoepidemiology and drug safety.
[42] M. Lipsitch,et al. Negative Controls: A Tool for Detecting Confounding and Bias in Observational Studies , 2010, Epidemiology.
[43] Robert T. Chen,et al. The Brighton Collaboration: Creating a Global Standard for Case Definitions (and Guidelines) for Adverse Events Following Immunization , 2005 .
[44] K. Rothman,et al. Health outcomes among patients receiving oseltamivir , 2004, Pharmacoepidemiology and drug safety.
[45] R. F. Allen. A Commentary , 1966 .
[46] Peter L. Elkin,et al. ICD90CM Claims Data are Insufficient for Influenza Surveillance , 2013, MedInfo.
[48] Canary Wharf,et al. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) , 2012 .
[49] S. Allison,et al. Power analysis. , 2004, The Journal of orthopaedic and sports physical therapy.