Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials

Randomized clinical trials are considered the milestones of clinical research in oncology, and guided the development and approval of new compounds so far. In the last few years, however, molecular and genomic profiling led to a change of paradigm in therapeutic algorithms of many cancer types, with...

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Autores principales:	Raimondo Di Liello, Maria Carmela Piccirillo, Laura Arenare, Piera Gargiulo, Clorinda Schettino, Adriano Gravina, Francesco Perrone
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	personalized medicine methodology clinical trials individualized treatment Science Q
Acceso en línea:	https://doaj.org/article/eabc4ca40ddd4d40aa7f5700bdd4a671
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spelling	oai:doaj.org-article:eabc4ca40ddd4d40aa7f5700bdd4a6712021-11-25T18:11:36ZMaster Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials10.3390/life111112532075-1729https://doaj.org/article/eabc4ca40ddd4d40aa7f5700bdd4a6712021-11-01T00:00:00Zhttps://www.mdpi.com/2075-1729/11/11/1253https://doaj.org/toc/2075-1729Randomized clinical trials are considered the milestones of clinical research in oncology, and guided the development and approval of new compounds so far. In the last few years, however, molecular and genomic profiling led to a change of paradigm in therapeutic algorithms of many cancer types, with the spread of different biomarker-driven therapies (or targeted therapies). This scenario of “personalized medicine” revolutionized therapeutic strategies and the methodology of the supporting clinical research. New clinical trial designs are emerging to answer to the unmet clinical needs related to the development of these targeted therapies, overcoming the “classical” structure of randomized studies. Innovative trial designs able to evaluate more than one treatment in the same group of patients or many groups of patients with the same treatment (or both) are emerging as a possible future standard in clinical trial methodology. These are identified as “master protocols”, and include umbrella, basket and platform trials. In this review, we described the main characteristics of these new trial designs, focusing on the opportunities and limitations of their use in the era of personalized medicine.Raimondo Di LielloMaria Carmela PiccirilloLaura ArenarePiera GargiuloClorinda SchettinoAdriano GravinaFrancesco PerroneMDPI AGarticlepersonalized medicinemethodologyclinical trialsindividualized treatmentScienceQENLife, Vol 11, Iss 1253, p 1253 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	personalized medicine methodology clinical trials individualized treatment Science Q
spellingShingle	personalized medicine methodology clinical trials individualized treatment Science Q Raimondo Di Liello Maria Carmela Piccirillo Laura Arenare Piera Gargiulo Clorinda Schettino Adriano Gravina Francesco Perrone Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials
description	Randomized clinical trials are considered the milestones of clinical research in oncology, and guided the development and approval of new compounds so far. In the last few years, however, molecular and genomic profiling led to a change of paradigm in therapeutic algorithms of many cancer types, with the spread of different biomarker-driven therapies (or targeted therapies). This scenario of “personalized medicine” revolutionized therapeutic strategies and the methodology of the supporting clinical research. New clinical trial designs are emerging to answer to the unmet clinical needs related to the development of these targeted therapies, overcoming the “classical” structure of randomized studies. Innovative trial designs able to evaluate more than one treatment in the same group of patients or many groups of patients with the same treatment (or both) are emerging as a possible future standard in clinical trial methodology. These are identified as “master protocols”, and include umbrella, basket and platform trials. In this review, we described the main characteristics of these new trial designs, focusing on the opportunities and limitations of their use in the era of personalized medicine.
format	article
author	Raimondo Di Liello Maria Carmela Piccirillo Laura Arenare Piera Gargiulo Clorinda Schettino Adriano Gravina Francesco Perrone
author_facet	Raimondo Di Liello Maria Carmela Piccirillo Laura Arenare Piera Gargiulo Clorinda Schettino Adriano Gravina Francesco Perrone
author_sort	Raimondo Di Liello
title	Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials
title_short	Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials
title_full	Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials
title_fullStr	Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials
title_full_unstemmed	Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials
title_sort	master protocols for precision medicine in oncology: overcoming methodology of randomized clinical trials
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/eabc4ca40ddd4d40aa7f5700bdd4a671
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Master Protocols for Precision Medicine in Oncology: Overcoming Methodology of Randomized Clinical Trials

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