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Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician

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 cr...

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Autores principales: Blonde, Lawrence, Khunti, Kamlesh, Harris, Stewart B., Meizinger, Casey, Skolnik, Neil S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223979/
https://www.ncbi.nlm.nih.gov/pubmed/30357570
http://dx.doi.org/10.1007/s12325-018-0805-y
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author Blonde, Lawrence
Khunti, Kamlesh
Harris, Stewart B.
Meizinger, Casey
Skolnik, Neil S.
author_facet Blonde, Lawrence
Khunti, Kamlesh
Harris, Stewart B.
Meizinger, Casey
Skolnik, Neil S.
author_sort Blonde, Lawrence
collection PubMed
description 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.
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spelling pubmed-62239792018-11-19 Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician Blonde, Lawrence Khunti, Kamlesh Harris, Stewart B. Meizinger, Casey Skolnik, Neil S. Adv Ther Review 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. Springer Healthcare 2018-10-24 2018 /pmc/articles/PMC6223979/ /pubmed/30357570 http://dx.doi.org/10.1007/s12325-018-0805-y Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Review
Blonde, Lawrence
Khunti, Kamlesh
Harris, Stewart B.
Meizinger, Casey
Skolnik, Neil S.
Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician
title Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician
title_full Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician
title_fullStr Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician
title_full_unstemmed Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician
title_short Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician
title_sort interpretation and impact of real-world clinical data for the practicing clinician
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223979/
https://www.ncbi.nlm.nih.gov/pubmed/30357570
http://dx.doi.org/10.1007/s12325-018-0805-y
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