HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force

(2022) Don Husereau et al.   VALUE IN HEALTH

Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance

(2021) Ashley Jaksa et al.   Journal of Comparative Effectiveness Research

The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework

(2021) Nicolle M. Gatto et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

How Can We Make More Rapid Progress in the Leveraging of Real-World Evidence by Regulatory Decision Makers?

(2021) Marc L. Berger et al.   VALUE IN HEALTH

Emulation Differences vs. Biases When Calibrating Real‐World Evidence Findings Against Randomized Controlled Trials

(2020) Jessica M. Franklin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility

(2020) Donna R. Rivera et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Issues in the registration of database studies

(2020) Deborah A. Zarin et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621.

(2020) Mandeep R. Mehra et al.   NEW ENGLAND JOURNAL OF MEDICINE

The Certainty Framework for Assessing Real‐World Data in Studies of Medical Product Safety and Effectiveness

(2020) Noelle M. Cocoros et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Improving transparency to build trust in real-world secondary data studies for hypothesis testing-Why, what, and how: recommendations and a road map from the real-world evidence transparency initiative

(2020) Lucinda S. Orsini et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative

(2020) Jessica M. Franklin et al.   CIRCULATION

Retraction of COVID-19 Pharmacoepidemiology Research Could Have Been Avoided by Effective Use of Reporting Guidelines

(2020) Eric I Benchimol et al.   Clinical Epidemiology

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

(2019) Rosa Gini et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Graphical Depiction of Longitudinal Study Designs in Health Care Databases

(2019) Sebastian Schneeweiss et al.   ANNALS OF INTERNAL MEDICINE

Using Real-World Data to Predict Findings of an Ongoing Phase IV Cardiovascular Outcome Trial: Cardiovascular Safety of Linagliptin Versus Glimepiride

(2019) Elisabetta Patorno et al.   DIABETES CARE

Data linkage in pharmacoepidemiology: A call for rigorous evaluation and reporting

(2019) Nicole L. Pratt et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Reduced Mortality With Sodium-Glucose Cotransporter–2 Inhibitors in Observational Studies

(2018) Samy Suissa   CIRCULATION

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

(2018) Xavier Kurz et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE)

(2018) Sinéad M Langan et al.   BMJ-British Medical Journal

Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0

(2017) Shirley V. Wang et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

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) Marc L. Berger et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Cardiovascular Outcomes and Risks After Initiation of a Sodium Glucose Cotransporter 2 Inhibitor

(2017) Jacob A. Udell et al.   CIRCULATION

Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available: Table 1.

(2016) Miguel A. Hernán et al.   AMERICAN JOURNAL OF EPIDEMIOLOGY

The FDA's sentinel initiative-A comprehensive approach to medical product surveillance

(2016) R Ball et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

(2016) Jonathan AC Sterne et al.   BMJ-British Medical Journal

ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

(2016) Jonathan AC Sterne et al.   BMJ-British Medical Journal

A Questionnaire to Assess the Relevance and Credibility of Observational Studies to Inform Health Care Decision Making: An ISPOR-AMCP-NPC Good Practice Task Force Report

(2014) Marc L. Berger et al.   VALUE IN HEALTH

Good Research Practices for Comparative Effectiveness Research: Approaches to Mitigate Bias and Confounding in the Design of Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report—Part II

(2009) Emily Cox et al.   VALUE IN HEALTH

Good Research Practices for Comparative Effectiveness Research: Analytic Methods to Improve Causal Inference from Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report—Part III

(2009) Michael L. Johnson et al.   VALUE IN HEALTH

Good Research Practices for Comparative Effectiveness Research: Defining, Reporting and Interpreting Nonrandomized Studies of Treatment Effects Using Secondary Data Sources: The ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report—Part I

(2009) Marc L. Berger et al.   VALUE IN HEALTH