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

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

Policies for Use of Real-World Data in Health Technology Assessment (HTA): A Comparative Study of Six HTA Agencies

(2017) Amr Makady et al.   VALUE IN HEALTH

Making sense of replications

(2017) Brian A Nosek et al.   eLife

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight

(2016) Pierre Engel et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Transparency and Reproducibility of Observational Cohort Studies Using Large Healthcare Databases.

(2016) SV Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Drug Regulation and Pricing — Can Regulators Influence Affordability?

(2016) Hans-Georg Eichler et al.   NEW ENGLAND JOURNAL OF MEDICINE

Transforming Evidence Generation to Support Health and Health Care Decisions

(2016) Robert M. Califf et al.   NEW ENGLAND JOURNAL OF MEDICINE

Reproducible Research Practices and Transparency across the Biomedical Literature

(2016) Shareen A. Iqbal et al.   PLOS BIOLOGY

The FAIR Guiding Principles for scientific data management and stewardship

(2016) Mark D. Wilkinson et al.   Scientific Data

DECISION-MAKING ALIGNED WITH RAPID-CYCLE EVALUATION IN HEALTH CARE

(2015) Sebastian Schneeweiss et al.   INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE

Identifying health outcomes in healthcare databases

(2015) Stephan Lanes et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Guidelines for good pharmacoepidemiology practice (GPP)

(2015)   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The cancer test

(2015) J. Kaiser   SCIENCE

Promoting an open research culture

(2015) B. A. Nosek et al.   SCIENCE

The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement

(2015) Eric I. Benchimol et al.   PLOS MEDICINE

The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines

(2015) Stuart G. Nicholls et al.   PLoS One

Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?

(2014) G. Trifirò et al.   JOURNAL OF INTERNAL MEDICINE

Launching PCORnet, a national patient-centered clinical research network

(2014) R. L. Fleurence et al.   JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION

PCORnet: turning a dream into reality

(2014) F. S. Collins et al.   JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION

Policy: NIH plans to enhance reproducibility

(2014) Francis S. Collins et al.   NATURE

Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials

(2014) Brian L. Strom et al.   NEW ENGLAND JOURNAL OF MEDICINE

Mini-Sentinel and Regulatory Science — Big Data Rendered Fit and Functional

(2014) Bruce M. Psaty et al.   NEW ENGLAND JOURNAL OF MEDICINE

Replication of the OMOP Experiment in Europe: Evaluating Methods for Risk Identification in Electronic Health Record Databases

(2013) Martijn J. Schuemie et al.   DRUG SAFETY

An Evaluation of the THIN Database in the OMOP Common Data Model for Active Drug Safety Surveillance

(2013) Xiaofeng Zhou et al.   DRUG SAFETY

Data Quality Assessment for Comparative Effectiveness Research in Distributed Data Networks

(2013) Jeffrey S. Brown et al.   MEDICAL CARE

The Asian Pharmacoepidemiology Network (AsPEN): promoting multi-national collaboration for pharmacoepidemiologic research in Asia

(2013) et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

A systematic review finds prediction models for chronic kidney disease were poorly reported and often developed using inappropriate methods

(2012) Gary S. Collins et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Raise standards for preclinical cancer research

(2012) C. Glenn Begley et al.   NATURE

The EU-ADR Web Platform: delivering advanced pharmacovigilance tools

(2012) José Luis Oliveira et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Reporting and Methods in Clinical Prediction Research: A Systematic Review

(2012) Walter Bouwmeester et al.   PLOS MEDICINE

Developing the Sentinel System — A National Resource for Evidence Development

(2011) Rachel E. Behrman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Guidelines for good database selection and use in pharmacoepidemiology research

(2011) Gillian C. Hall et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Development and use of reporting guidelines for assessing the quality of validation studies of health administrative data

(2010) Eric I. Benchimol et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Confounding Control in Healthcare Database Research

(2010) M. Alan Brookhart et al.   MEDICAL CARE

Immortal Time Bias in Pharmacoepidemiology

(2007) S. Suissa   AMERICAN JOURNAL OF EPIDEMIOLOGY