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

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Adding/removing text We have identified three instances where we incorrectly used quotation marks although the wording parphrased the guideline rather than quoting it verbatim. In addition, one incorrect section reference to the EMA FIH guideline has been identified. We note that in each instance the meaning remains unchanged. However, we wish to correct these instances to avoid attributing wording to the EMA FIH guideline.All corrections concern Section 2.2 "Decision criteria for progressing between trial parts" 1. 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."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.The original version of this article has been updated. 2. 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.The original version of this article has been updated.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).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.The original version of this article has been updated.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.End of template. If you would like to request a correction for a reason not seen here, please contact the journal's editorial office.

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