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Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center

Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center
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United States , Robert Ball , Ghana Lee , Pharmacovigilance Enc , Jenniferc Nelson , Monte Carlo , Jie Li , Sengwee Toh , Richard Wyss , Xu Shi , Sushama Kattinakere Sreedhara , Miguela Hern , Gerald Dal Pan , Shirleyv Wang , Sebastian Schneeweiss , Sarah Dutcher , Samy Suissa , Jodib Segal , Kennethj Rothman , Luke Zabotka , Patrickj Heagerty , Sander Greenland , Farzin Khosrow Khavar , Science Foundation , European Network Of Centres , Boehringer Ingelheim ,

Why Stating Hypotheses in Grant Applications Is Unnecessary

This Viewpoint argues that a hypothesis-centric approach to writing grant applications is problematic and instead suggests that funding applications should be e ....

United States , Miguela Hern , National Institutes Of Health , Department Of Epidemiology , Veterans Administration , Public Health , Interest Disclosures , National Institutes ,

Combining high quality data with rigorous methods: emulation of a target trial using electronic health records and a nested case-control design

Emulating a target trial reduces the potential for bias in observational comparative effectiveness research. Owing to feasibility constraints, large cohort studies often use electronic health records without validating key variables or collecting additional data. A case-control design allows researchers to validate, supplement, or collect additional data on key measurements in a much smaller sample compared with the entire cohort. In this article, Rasouli and colleagues describe methods to emulate a target trial using a nested case-control design, and provide a detailed guideline, an analytical program, and results of a clinical example.

#### Summary points

Randomized controlled trials are considered the ideal study design for comparative effectiveness research. Given that such trials are usually costly, lengthy, and, in some instances, unethical or infeasible, interest is increasing in using observational studies such as those conducted using data from electronic health ....

District Of Columbia , United States , Rogerw Logan , Miguela Hern , Matthew Nguyen , Kerril Wiggins , Brucem Psaty , Barbraa Dickerman , Kelly Meyers , Goodarz Danaei , Jessica Chubak , Bahareh Rasouli , Jamess Floyd , Kaiser Permanente , Kaiser Permanente Washington Health Research Institute , Novo Nordisk Foundation , Novo Nordisk Foundation No , Outcomes Research Institute , Vascular Health , Primary Prevention , Kaiser Permanente Washington , Public Health Research , Kaiser Permanente Washington Region , Kaiser Permanente Washington Health Research , Patient Centered Outcomes Research Institute ,

Combining Data Science RWE For Better Clinical Outcomes For Immunological Diseases

As we continue to better understand immune-mediated inflammatory diseases, Janssen is applying machine learning and artificial intelligence to. ....

United States , Jamesm Robins , Miguela Hern , Hemanth Kanakamedala , Effectiveness Research After Product , Identification And Development , Janssen Pharmaceutical Companies Of Johnson , Janssen Pharmaceutical Companies , Design Smarter , More Efficient , More Representative Clinical , Real World Endpoints Into , Using Big Data , Target Trial When , Randomized Trial Is Not Available , American Journal ,

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