In the published article there were three instances of incorrectly used quotation marks although the wording paraphrased the guideline rather than quoting it verbatim. In addition, one incorrect section reference to the EMA FIH guideline has been identified.
A correction has been made to section 2.2, paragraph 1. In the published article, the text reads:
According to EMA FIH (Section 8.2.1): “The protocol should define dose escalation and stopping rules and other criteria guiding the decision to progress from one part of the trial to another.”
This has been corrected to read:
In line with EMA FIH Sections 7.4, 8.2.2 and 8.2.9, the protocol should define dose escalation criteria, stopping rules and criteria guiding the decision to progress from one trial part to another.
A correction has been made to section 2.2, paragraph 2. In the published article, the text reads:
Section 6.7 of the guideline further requires that for patient populations, the starting dose is expected to have a minimal pharmacological effect and must be safe to use
This has been corrected to read:
Section 7.3 of the guideline further requires that for patient populations, the starting dose is expected to have a minimal pharmacological effect and must be safe to use.
A correction has been made to section 2.2, paragraph 3. In the published article, the text reads:
The guideline emphasises that escalation steps should be conservative and justified, especially once a pharmacologically active range has been reached. It explicitly advises that “when pharmacodynamic activity has been reached, dose increments above a two-fold increase should be avoided unless appropriately justified” (EMA FIH, Section 8.2.2).
This has been corrected to read:
The guideline emphasises that escalation steps should be conservative and justified, especially once a pharmacologically active range has been reached (EMA FIH, Sections 7.4, 7.5). Based on the consensus process reported in this article, when pharmacodynamic activity has been reached, dose increments above a two-fold increase should be avoided unless appropriately justified.
A correction has been made to section 2.2, paragraph 5. In the published article, the text reads:
Optional parts and flexible design elements (e.g., optional cohorts) must also follow predefined boundaries. As stated in Section 8.2.2: “All parts and options within an integrated protocol should be predefined, and the data to be used to make decisions about proceeding should be clearly described.”
This has been corrected to read:
Optional parts and flexible design elements (e.g., optional cohorts) must also follow predefined boundaries. In line with EMA FIH sections 8.2.2 and 8.2.8, all parts and options within an integrated protocol should be predefined, and the data to be used to make decisions about proceeding should be clearly described.
The original version of this article has been updated.
Statements
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
Summary
Keywords
clinical trials, complex trial design, first-in-human, integrated protocols, investigational medicinal product, substantial modification
Citation
Schultz-Heienbrok R, Baumann S, Böhm R, Bonertz A, Breithaupt-Groegler K, Buckpesch-Heberer U, Coenen M, Erb-Zohar K, Faisst N, Grass G, Höchel J, Kovar A, Muehlenbroich A, Rengelshausen J, Riedel C, Schug B, Sudhop T, Warnke A and Ziegele B (2026) Correction: Designing integrated early-phase protocols to reduce substantial modifications, including considerations for patient cohorts – a multi-stakeholder consensus view for a practical approach in Germany. Front. Pharmacol. 17:1948963. doi: 10.3389/fphar.2026.1948963
Received
26 July 2026
Accepted
10 August 2026
Published
02 September 2026
Volume
17 - 2026
Edited and reviewed by
Bernd Rosenkranz, Fundisa African Academy of Medicines Development, South Africa
Updates
Copyright
© 2026 Schultz-Heienbrok, Baumann, Böhm, Bonertz, Breithaupt-Groegler, Buckpesch-Heberer, Coenen, Erb-Zohar, Faisst, Grass, Höchel, Kovar, Muehlenbroich, Rengelshausen, Riedel, Schug, Sudhop, Warnke and Ziegele.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: R. Schultz-Heienbrok, robert.schultz-heienbrok@charite-research.org
ORCID: S. Baumann, orcid.org/0000-0001-7024-536X; M. Coenen, orcid.org/0000-0003-0439-4409
Disclaimer
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.