Master protocols in clinical trials : a universal Swiss Army knife?
Sudhop, Thomas ; Brun, Nikolai Constantin ; Riedel, Claudia ; Rosso, Aldana LU
; Broich, Karl
and Senderovitz, Thomas
(2019)
In The Lancet Oncology
20(6).
p.336-342
- Abstract
Master protocols combine several sub-trials, each with their own research objectives, which is usually presented as one single clinical trial application. Master protocols have become increasingly popular in oncology and haematology, as either basket, umbrella, or platform trials. Although master protocols are intended to accelerate drug development and to reduce futility, their use poses challenges to ethics committees, patients, study investigators, and competent authorities during the review and authorisation process of a clinical trial application. In this Personal View, we review the experiences of clinical trial applications from two European medical regulators-the Danish Medicines Agency and the German Federal Institute for Drugs... (More)
Master protocols combine several sub-trials, each with their own research objectives, which is usually presented as one single clinical trial application. Master protocols have become increasingly popular in oncology and haematology, as either basket, umbrella, or platform trials. Although master protocols are intended to accelerate drug development and to reduce futility, their use poses challenges to ethics committees, patients, study investigators, and competent authorities during the review and authorisation process of a clinical trial application. In this Personal View, we review the experiences of clinical trial applications from two European medical regulators-the Danish Medicines Agency and the German Federal Institute for Drugs and Medical Devices. We view master protocols as a good opportunity to identify new treatment options more quickly, particularly for patients with cancer. However, the complexity of trial documentation, the amount of information resulting from sub-trials, and the volume of changes and amendments made to clinical trial applications can cause issues during trial supervision, and during the analysis and review of a corresponding application for marketing authorisation. We draw attention to the potential issues arising from these trial concepts and propose possible solutions to avoid problems during clinical trial authorisation and trial conduct.
(Less)
- author
- Sudhop, Thomas
; Brun, Nikolai Constantin
; Riedel, Claudia
; Rosso, Aldana
LU
; Broich, Karl
and Senderovitz, Thomas
- organization
- publishing date
- 2019-06
- type
- Contribution to journal
- publication status
- published
- subject
- in
- The Lancet Oncology
- volume
- 20
- issue
- 6
- pages
- 336 - 342
- publisher
- Elsevier
- external identifiers
-
- pmid:31162107
- scopus:85067170649
- ISSN
- 1474-5488
- DOI
- 10.1016/S1470-2045(19)30271-2
- language
- English
- LU publication?
- no
- additional info
- Copyright © 2019 Elsevier Ltd. All rights reserved.
- id
- 9c616c96-7141-47dc-9320-e22597fac60e
- date added to LUP
- 2020-01-30 21:53:11
- date last changed
- 2025-05-15 17:21:06
@article{9c616c96-7141-47dc-9320-e22597fac60e,
abstract = {{<p>Master protocols combine several sub-trials, each with their own research objectives, which is usually presented as one single clinical trial application. Master protocols have become increasingly popular in oncology and haematology, as either basket, umbrella, or platform trials. Although master protocols are intended to accelerate drug development and to reduce futility, their use poses challenges to ethics committees, patients, study investigators, and competent authorities during the review and authorisation process of a clinical trial application. In this Personal View, we review the experiences of clinical trial applications from two European medical regulators-the Danish Medicines Agency and the German Federal Institute for Drugs and Medical Devices. We view master protocols as a good opportunity to identify new treatment options more quickly, particularly for patients with cancer. However, the complexity of trial documentation, the amount of information resulting from sub-trials, and the volume of changes and amendments made to clinical trial applications can cause issues during trial supervision, and during the analysis and review of a corresponding application for marketing authorisation. We draw attention to the potential issues arising from these trial concepts and propose possible solutions to avoid problems during clinical trial authorisation and trial conduct.</p>}},
author = {{Sudhop, Thomas and Brun, Nikolai Constantin and Riedel, Claudia and Rosso, Aldana and Broich, Karl and Senderovitz, Thomas}},
issn = {{1474-5488}},
language = {{eng}},
number = {{6}},
pages = {{336--342}},
publisher = {{Elsevier}},
series = {{The Lancet Oncology}},
title = {{Master protocols in clinical trials : a universal Swiss Army knife?}},
url = {{http://dx.doi.org/10.1016/S1470-2045(19)30271-2}},
doi = {{10.1016/S1470-2045(19)30271-2}},
volume = {{20}},
year = {{2019}},
}