scholarly journals Development of a System for Postmarketing Population Pharmacokinetic and Pharmacodynamic Studies Using Real‐World Data From Electronic Health Records

2020 ◽  
Vol 107 (4) ◽  
pp. 934-943 ◽  
Author(s):  
Leena Choi ◽  
Cole Beck ◽  
Elizabeth McNeer ◽  
Hannah L. Weeks ◽  
Michael L. Williams ◽  
...  
Keyword(s):  
Electronic Health Records ◽  
Real World ◽  
Population Pharmacokinetic ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Electronic Health

Assessing function of electronic health records for real-world data generation

2018 ◽  
Vol 24 (3) ◽  
pp. 95-98 ◽  
Author(s):  
Daphne Guinn ◽  
Erin E Wilhelm ◽  
Grazyna Lieberman ◽  
Sean Khozin
Keyword(s):  
Electronic Health Records ◽  
Real World ◽  
Data Generation ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Electronic Health

scholarly journals Use of Real-World Data for the Research, Development, and Evaluation of Oncology Precision Medicines

2017 ◽  
pp. 1-11 ◽  
Author(s):  
Jan R.R. Lewis ◽  
Ian Kerridge ◽  
Wendy Lipworth
Keyword(s):  
Electronic Health Records ◽  
Real World ◽  
Late Phase ◽  
Data Sets ◽  
Patient Identification ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Electronic Health ◽  
New Treatments

Although randomized controlled trials remain the scientific ideal for determining the efficacy and safety of new treatments, they are sometimes insufficient to address the evidentiary requirements of regulators and payers. This is particularly the case when it comes to precision medicines because trials are often small, deliver incomplete insights into outcomes of most interest to policymakers (eg, overall survival), and may fail to address other complex diagnostic and treatment-related questions. Additional methods, both experimental and observational, are increasingly being used to fill critical evidentiary gaps. A number of modified early- and late-phase trial designs have been proposed to better support earlier biomarker validation, patient identification, and selection for regulatory studies, but there is still a need for confirmatory evidence from real-world data sources. These data are usually provided through observational, postapproval, phase IIIB and IV studies, which rely heavily on registries and other electronic data sets—most notably data from electronic health records. It is, therefore, crucial to understand what ethical, practical, and scientific challenges are raised by the use of electronic health records to generate evidence about precision medicines.

An artificial intelligence framework integrating longitudinal electronic health records with real-world data enables continuous pan-cancer prognostication

Nature Cancer ◽  
2021 ◽  
Vol 2 (7) ◽  
pp. 709-722 ◽  
Author(s):  
Olivier Morin ◽  
Martin Vallières ◽  
Steve Braunstein ◽  
Jorge Barrios Ginart ◽  
Taman Upadhaya ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Electronic Health Records ◽  
Real World ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Electronic Health ◽  
Pan Cancer

scholarly journals Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review

2020 ◽  
Author(s):  
James R Rogers ◽  
Junghwan Lee ◽  
Ziheng Zhou ◽  
Ying Kuen Cheung ◽  
George Hripcsak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
Scoping Review ◽  
Real World ◽  
Administrative Claims ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Trial Process

Abstract Objective Real-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes. Materials and Methods Querying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions. Results Of 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values. Discussion Database-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use. Conclusion Enhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.

scholarly journals Comparing SDTM and FHIR® for Real World Data from Electronic Health Records for Clinical Trial Submissions

2021 ◽  
Author(s):  
Sarah Riepenhausen ◽  
Cornelia Mertens ◽  
Martin Dugas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Data Submission

Real world data for use in clinical trials is promising. We compared the SDTM for clinical trial data submission with FHIR® for routine documentation. After categorization of variables by relevance, clinically relevant SDTM items were mapped to FHIR®. About 30% in both were seen as clinically relevant. The majority of these SDTM items were mappable to FHIR® Observation resource.

scholarly journals What Every Reader Should Know About Studies Using Electronic Health Record Data But Is Afraid To Ask (Preprint)

2020 ◽  
Author(s):  
Isaac S Kohane ◽  
Bruce J Aronow ◽  
Paul Avillach ◽  
Brett K Beaulieu-Jones ◽  
Riccardo Bellazzi ◽  
...  
Keyword(s):  
Electronic Health Records ◽  
Electronic Health Record ◽  
Real World ◽  
Warning Signs ◽  
Health Record ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Health Records ◽  
Record Data ◽  
Electronic Health

UNSTRUCTURED Coincident with the tsunami of Covid19-related manuscripts, there has been a surge of studies using Real World Data (RWD), including those obtained from electronic health records. Unfortunately, several of these studies have resulted in withdrawn publication because of concerns regarding their soundness and quality. We argue here that there are pre-analytic hints and warning signs that are useful in judging RWD studies that might otherwise pass statistical muster. We outline several of these signs and suggest that review of RWD manuscripts include those who are familiar with how such data are generated.

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