Clinical Trial Generalizability Assessment in the Big Data Era: A Review

Author:

He Zhe1ORCID,Tang Xiang2,Yang Xi3,Guo Yi3,George Thomas J.4ORCID,Charness Neil5,Quan Hem Kelsa Bartley6ORCID,Hogan William3ORCID,Bian Jiang3

Affiliation:

1. School of Information Florida State University Tallahassee Florida USA

2. Department of Statistics Florida State University Tallahassee Florida USA

3. Department of Health Outcomes and Biomedical Informatics College of Medicine University of Florida Gainesville Florida USA

4. Hematology & Oncology Department of Medicine College of Medicine University of Florida Gainesville Florida USA

5. Department of Psychology Florida State University Tallahassee Florida USA

6. Calder Memorial Library Miller School of Medicine University of Miami Miami Florida USA

Funder

National Institute on Aging

National Institutes of Health

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference71 articles.

1. From the NIH Director: the importance of clinical trials. Accessed April 1 2019.

2. External and internal validity in clinical trials

3. Reevaluating Eligibility Criteria — Balancing Patient Protection and Participation in Oncology Trials

4. Exclusion of Pregnant Women From Industry-Sponsored Clinical Trials

5. US Food and Drug Administration.Enhancing the diversity of clinical trial populations—eligibility criteria enrollment practices and trial designs guidance for industry (2019). Accessed August 5 2019.

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