Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician.pdf (519.82 kB)
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Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician.

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posted on 10.04.2019, 10:47 by Lawrence Blonde, Kamlesh Khunti, Stewart B. Harris, Casey Meizinger, Neil S. Skolnik
Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the "gold standard" for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.Funding: Sanofi US, Inc.

Funding

KK acknowledges support from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care-East Midlands (CLAHRC-EM) and the NIHR Leicester Biomedical Research Centre. Funding, including article processing charges and Open Access fee, was provided by Sanofi US, Inc.

History

Citation

Advances in Therapy, 2018, 35 (11), pp. 1763-1774

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Diabetes Research Centre

Version

VoR (Version of Record)

Published in

Advances in Therapy

Publisher

Springer (part of Springer Nature)

eissn

1865-8652

Copyright date

2018

Available date

10/04/2019

Publisher version

https://link.springer.com/article/10.1007/s12325-018-0805-y

Notes

To view enhanced digital features for this article go to https://doi.org/10.6084/m9.figshare.7156850.

Language

en

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