Cargando…

The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation

The randomised controlled trial (RCT) has been considered for a long time as the gold standard for evidence generation to support regulatory decision making for medicines. The randomisation procedure involves an ethical dilemma since it means leaving the treatment choice to chance. Although currentl...

Descripción completa

Detalles Bibliográficos
Autor principal: Callréus, Torbjörn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9309994/
https://www.ncbi.nlm.nih.gov/pubmed/35877037
http://dx.doi.org/10.1007/s40290-022-00438-8
_version_ 1784753294072086528
author Callréus, Torbjörn
author_facet Callréus, Torbjörn
author_sort Callréus, Torbjörn
collection PubMed
description The randomised controlled trial (RCT) has been considered for a long time as the gold standard for evidence generation to support regulatory decision making for medicines. The randomisation procedure involves an ethical dilemma since it means leaving the treatment choice to chance. Although currently contested, the ethical justification for the RCT that has gained widespread acceptance is the notion of ‘clinical equipoise’. This state exists when “there is no consensus within the expert clinical community about the comparative merits of the alternatives to be tested”; it is argued that this confers the ethical grounds for the conduct of an RCT. The prominent position of the RCT is being challenged by new therapeutic modalities for which this study design may be unsuitable. Moreover, alternative approaches to evidence generation represent another area where innovation may have implications for the relevance of the RCT. Against the backdrop of the debate around the equipoise principle and some recent therapeutic and data analytical innovations, the aim of this article is to explore the current standing of the RCT from a regulatory perspective.
format Online
Article
Text
id pubmed-9309994
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-93099942022-07-25 The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation Callréus, Torbjörn Pharmaceut Med Leading Article The randomised controlled trial (RCT) has been considered for a long time as the gold standard for evidence generation to support regulatory decision making for medicines. The randomisation procedure involves an ethical dilemma since it means leaving the treatment choice to chance. Although currently contested, the ethical justification for the RCT that has gained widespread acceptance is the notion of ‘clinical equipoise’. This state exists when “there is no consensus within the expert clinical community about the comparative merits of the alternatives to be tested”; it is argued that this confers the ethical grounds for the conduct of an RCT. The prominent position of the RCT is being challenged by new therapeutic modalities for which this study design may be unsuitable. Moreover, alternative approaches to evidence generation represent another area where innovation may have implications for the relevance of the RCT. Against the backdrop of the debate around the equipoise principle and some recent therapeutic and data analytical innovations, the aim of this article is to explore the current standing of the RCT from a regulatory perspective. Springer International Publishing 2022-07-25 2022 /pmc/articles/PMC9309994/ /pubmed/35877037 http://dx.doi.org/10.1007/s40290-022-00438-8 Text en © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Leading Article
Callréus, Torbjörn
The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
title The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
title_full The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
title_fullStr The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
title_full_unstemmed The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
title_short The Randomised Controlled Trial at the Intersection of Research Ethics and Innovation
title_sort randomised controlled trial at the intersection of research ethics and innovation
topic Leading Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9309994/
https://www.ncbi.nlm.nih.gov/pubmed/35877037
http://dx.doi.org/10.1007/s40290-022-00438-8
work_keys_str_mv AT callreustorbjorn therandomisedcontrolledtrialattheintersectionofresearchethicsandinnovation
AT callreustorbjorn randomisedcontrolledtrialattheintersectionofresearchethicsandinnovation