References¶
Every web site and publication cited in the book, by where it is cited, followed by further resources. Definitions of the terms are in the glossary.
Cited in the book¶
How to Use This Book¶
Chapter 1: Decide who the data are for¶
Chapter 2: Start with the analysis plan¶
Chapter 4: Decide what to capture before you go looking¶
Chapter 9: Keep records someone else could read¶
Chapter 12: Go and find out why the data are missing¶
Chapter 16: Have the conversations only you can have¶
Chapter 18: Build so that a machine can use it¶
Further resources¶
Guidance and standards¶
- STROBE reporting checklist (Strengthening the Reporting of Observational Studies in Epidemiology)
- FDA Drug Development Tool Qualification Programs
- Wilkinson MD, et al. The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data. 2016. doi:10.1038/sdata.2016.18
Reproducibility and real world evidence¶
- Ostropolets A, et al. Reproducible variability: assessing investigator discordance across 9 research teams attempting to reproduce the same observational study. JAMIA. 2023. doi:10.1093/jamia/ocad009
- Wang SV, Sreedhara SK, Schneeweiss S, REPEAT Initiative. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nature Communications. 2022;13:5126. doi:10.1038/s41467-022-32310-3
- Cai CX, Hribar M, Baxter S, et al. Semaglutide and nonarteritic anterior ischemic optic neuropathy. JAMA Ophthalmology. 2025;143(4):304-314. doi:10.1001/jamaophthalmol.2024.6555
Consortia¶
- Critical Path Institute, which convenes the consortia that work with regulators on drug development tools
Missing data¶
- van Buuren S. Flexible Imputation of Missing Data. A standard reference on multiple imputation and the assumptions behind it.
Open standards and tools¶
- The Book of OHDSI
- Athena, OHDSI's browser for the OMOP standardized vocabularies
- ATLAS demonstration site, OHDSI's tool for cohort definitions and analyses
- Human Phenotype Ontology
- PubMed and ClinicalTrials.gov
From Boyce Data Science¶
- Boyce D, Premasiri A, Sullivan S, Levine B, Vieira FG. Registry Forge: an open-source end-to-end pipeline for patient-directed SMART on FHIR registries. JAMIA Open. 2026;9(5):ooag200. doi:10.1093/jamiaopen/ooag200
- Registry Forge and Registry Forge, Patient Edition
- The Ten Habits Series, including Ten Habits of Great Data Analysts
- Demonstration registry, a mock-up of a multi-condition registry seen from both sides: the participant journey, with live counts of the questions asked, and the study team's workspace
- Boyce Data Science