Cargando…

Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes

Randomized controlled trials (RCTs) sponsored by pharmaceutical manufacturers for regulatory approval are conducted with restrictive criteria in an effort to definitively demonstrate the safety and efficacy of a drug or biologic. Unfortunately, the strict enrollment criteria in RCTs may exclude pati...

Descripción completa

Detalles Bibliográficos
Autor principal: Redell, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7334307/
https://www.ncbi.nlm.nih.gov/pubmed/32588383
http://dx.doi.org/10.1007/s40801-020-00189-5
_version_ 1783553912937119744
author Redell, Mark
author_facet Redell, Mark
author_sort Redell, Mark
collection PubMed
description Randomized controlled trials (RCTs) sponsored by pharmaceutical manufacturers for regulatory approval are conducted with restrictive criteria in an effort to definitively demonstrate the safety and efficacy of a drug or biologic. Unfortunately, the strict enrollment criteria in RCTs may exclude patients likely to receive the medication in a real-world clinical practice. Antibiotic RCTs for registration are designed to show noninferiority against standard of care or best available therapy, often minimizing clinical differentiation needed by clinicians to select the optimal agent for their patients. Lastly, RCTs do not include pharmacoeconomic data that would add a cost basis for determining the value of one product over another. Real-world studies may add support to the safety and efficacy demonstrated from RCTs and address patient populations excluded from clinical development programs. This supplement presents several real-world studies demonstrating the clinical and economic outcomes of various uses of oritavancin to augment the evidence published from RCTs. Clinicians may decide how to use this information in their own practice settings.
format Online
Article
Text
id pubmed-7334307
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-73343072020-07-09 Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes Redell, Mark Drugs Real World Outcomes Commentary Randomized controlled trials (RCTs) sponsored by pharmaceutical manufacturers for regulatory approval are conducted with restrictive criteria in an effort to definitively demonstrate the safety and efficacy of a drug or biologic. Unfortunately, the strict enrollment criteria in RCTs may exclude patients likely to receive the medication in a real-world clinical practice. Antibiotic RCTs for registration are designed to show noninferiority against standard of care or best available therapy, often minimizing clinical differentiation needed by clinicians to select the optimal agent for their patients. Lastly, RCTs do not include pharmacoeconomic data that would add a cost basis for determining the value of one product over another. Real-world studies may add support to the safety and efficacy demonstrated from RCTs and address patient populations excluded from clinical development programs. This supplement presents several real-world studies demonstrating the clinical and economic outcomes of various uses of oritavancin to augment the evidence published from RCTs. Clinicians may decide how to use this information in their own practice settings. Springer International Publishing 2020-06-25 /pmc/articles/PMC7334307/ /pubmed/32588383 http://dx.doi.org/10.1007/s40801-020-00189-5 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Commentary
Redell, Mark
Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes
title Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes
title_full Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes
title_fullStr Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes
title_full_unstemmed Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes
title_short Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes
title_sort real-world evidence studies of oritavancin use in gram-positive infections augment randomized controlled trials to address clinical and economic outcomes
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7334307/
https://www.ncbi.nlm.nih.gov/pubmed/32588383
http://dx.doi.org/10.1007/s40801-020-00189-5
work_keys_str_mv AT redellmark realworldevidencestudiesoforitavancinuseingrampositiveinfectionsaugmentrandomizedcontrolledtrialstoaddressclinicalandeconomicoutcomes