Observational research in epidemic settings: a roadmap to reform

Observational studies are critical tools in clinical research and public health response, but challenges arise in ensuring the data produced by these studies are scientifically robust and socially valuable. Resolving these challenges requires careful attention to prioritising the most valuable resea...

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Main Authors: Marc Lipsitch, Nicholas Evans, Alexandra L Phelan, Stephany N Duda, Annette Rid, Colin J Carlson, Jennifer B Rosen, Natalie E Dean, John Barugahare, Maya B Mathur, Emily E Ricotta, Fausto A Bustos Carrillo, Samuel Angelli-Nichols, Adia Benton, Emma Chang-Rabley, Lisa Federer, Mary-Margaret A Fill, Elizabeth C LeRoy, Natalie M Linton, Lauren Sauer, Sheena G Sullivan, Mackenzie Zendt
Format: Article
Language:English
Published: BMJ Publishing Group 2025-02-01
Series:BMJ Global Health
Online Access:https://gh.bmj.com/content/10/2/e017981.full
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author Marc Lipsitch
Nicholas Evans
Alexandra L Phelan
Stephany N Duda
Annette Rid
Colin J Carlson
Jennifer B Rosen
Natalie E Dean
John Barugahare
Maya B Mathur
Emily E Ricotta
Fausto A Bustos Carrillo
Samuel Angelli-Nichols
Adia Benton
Emma Chang-Rabley
Lisa Federer
Mary-Margaret A Fill
Elizabeth C LeRoy
Natalie M Linton
Lauren Sauer
Sheena G Sullivan
Mackenzie Zendt
author_facet Marc Lipsitch
Nicholas Evans
Alexandra L Phelan
Stephany N Duda
Annette Rid
Colin J Carlson
Jennifer B Rosen
Natalie E Dean
John Barugahare
Maya B Mathur
Emily E Ricotta
Fausto A Bustos Carrillo
Samuel Angelli-Nichols
Adia Benton
Emma Chang-Rabley
Lisa Federer
Mary-Margaret A Fill
Elizabeth C LeRoy
Natalie M Linton
Lauren Sauer
Sheena G Sullivan
Mackenzie Zendt
author_sort Marc Lipsitch
collection DOAJ
description Observational studies are critical tools in clinical research and public health response, but challenges arise in ensuring the data produced by these studies are scientifically robust and socially valuable. Resolving these challenges requires careful attention to prioritising the most valuable research questions, ensuring robust study design, strong data management practices, expansive community engagement, and access and benefit sharing of results and research materials. This paper opens with a discussion of how well-designed observational studies contribute to biomedical evidence and provides examples from across the clinical literature of how these methods generate hypotheses for future research and uncover otherwise unattainable insights by providing examples from across the clinical literature. Then, we present obstacles that remain in ensuring observational studies are optimally designed, conducted and communicated.
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series BMJ Global Health
spelling doaj-art-24f73f00365c4282bc91fabcb20057272025-02-11T08:45:10ZengBMJ Publishing GroupBMJ Global Health2059-79082025-02-0110210.1136/bmjgh-2024-017981Observational research in epidemic settings: a roadmap to reformMarc Lipsitch0Nicholas Evans1Alexandra L Phelan2Stephany N Duda3Annette Rid4Colin J Carlson5Jennifer B Rosen6Natalie E Dean7John Barugahare8Maya B Mathur9Emily E Ricotta10Fausto A Bustos Carrillo11Samuel Angelli-Nichols12Adia Benton13Emma Chang-Rabley14Lisa Federer15Mary-Margaret A Fill16Elizabeth C LeRoy17Natalie M Linton18Lauren Sauer19Sheena G Sullivan20Mackenzie Zendt21Harvard T H Chan School of Public Health, Boston, Massachusetts, USADepartment of Philosophy, University of Massachusetts Lowell, Lowell, Massachusetts, USAJohns Hopkins Center for Health Security, Baltimore, Maryland, USADepartment of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, USADepartment of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USACenter for Global Health Science & Security, Georgetown University, Washington, District of Columbia, USABureau of Immunization, New York City Department of Health and Mental Hygiene, New York, New York, USADepartment of Biostatistics & Bioinformatics, Emory University, Atlanta, Georgia, USADepartment of Philosophy, Makerere University, Kampala, UgandaQuantitative Sciences Unit, Stanford University, Stanford, California, USAEpidemiology and Data Management Unit, National Institute of Allergy and Infectious Diseases Division of Intramural Research, Bethesda, Maryland, USAEpidemiology and Data Management Unit, National Institute of Allergy and Infectious Diseases Division of Intramural Research, Bethesda, Maryland, USADepartment of Philosophy, University of Massachusetts Lowell, Lowell, Massachusetts, USADepartment of Anthropology, Northwestern University, Evanston, Illinois, USAEpidemiology and Data Management Unit, National Institute of Allergy and Infectious Diseases Division of Intramural Research, Bethesda, Maryland, USAOffice of Strategic Initiatives, National Library of Medicine, Bethesda, Maryland, USADivision of Communicable and Environmental Diseases and Emergency Preparedness, Tennessee Department of Health, Nashville, Tennessee, USACDISC, Austin, Texas, USACenter for Infectious Diseases, California Department of Public Health, Sacramento, California, USAGlobal Center for Health Security, University of Nebraska Medical Center, Omaha, Nebraska, USAWHO Collaborating Centre for Reference and Research on Influenza, The Royal Melbourne Hospital, Melbourne, Victoria, AustraliaEpidemiology and Data Management Unit, National Institute of Allergy and Infectious Diseases Division of Intramural Research, Bethesda, Maryland, USAObservational studies are critical tools in clinical research and public health response, but challenges arise in ensuring the data produced by these studies are scientifically robust and socially valuable. Resolving these challenges requires careful attention to prioritising the most valuable research questions, ensuring robust study design, strong data management practices, expansive community engagement, and access and benefit sharing of results and research materials. This paper opens with a discussion of how well-designed observational studies contribute to biomedical evidence and provides examples from across the clinical literature of how these methods generate hypotheses for future research and uncover otherwise unattainable insights by providing examples from across the clinical literature. Then, we present obstacles that remain in ensuring observational studies are optimally designed, conducted and communicated.https://gh.bmj.com/content/10/2/e017981.full
spellingShingle Marc Lipsitch
Nicholas Evans
Alexandra L Phelan
Stephany N Duda
Annette Rid
Colin J Carlson
Jennifer B Rosen
Natalie E Dean
John Barugahare
Maya B Mathur
Emily E Ricotta
Fausto A Bustos Carrillo
Samuel Angelli-Nichols
Adia Benton
Emma Chang-Rabley
Lisa Federer
Mary-Margaret A Fill
Elizabeth C LeRoy
Natalie M Linton
Lauren Sauer
Sheena G Sullivan
Mackenzie Zendt
Observational research in epidemic settings: a roadmap to reform
BMJ Global Health
title Observational research in epidemic settings: a roadmap to reform
title_full Observational research in epidemic settings: a roadmap to reform
title_fullStr Observational research in epidemic settings: a roadmap to reform
title_full_unstemmed Observational research in epidemic settings: a roadmap to reform
title_short Observational research in epidemic settings: a roadmap to reform
title_sort observational research in epidemic settings a roadmap to reform
url https://gh.bmj.com/content/10/2/e017981.full
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