Steeghs, Neeltje
Pruis, Melinda
van Herpen, Carla
Lu, Vickie
Redman, John
Zhou, Xiaofei
Article History
Received: 24 August 2022
Accepted: 7 November 2022
First Online: 21 November 2022
Declarations
:
: The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, in accordance with the International Conference on Harmonisation Good Clinical Practice standards and applicable regulatory requirements, and in compliance with the Institutional Review Board regulations stated in the Good Clinical Practice regulations and guidelines.
: This study was conducted in compliance with the informed consent regulations stated in the Good Clinical Practice regulations and guidelines. The investigator explained the study, including its objectives and potential risks and benefits, to patients using the informed consent form that had been approved by the Institutional Review Board/Independent Ethics Committee at each study site. Each patient signed and dated the informed consent form before any protocol-specific screening procedures.
: Not applicable.
: This study was conducted in compliance with the Institutional Review Board regulations, Good Clinical Practice regulations and guidelines, and all applicable local regulations. The clinical study protocol, the investigator’s brochure, a sample informed consent form, and other study-related documents were reviewed and approved by the local or central Institutional Review Board/Independent Ethics Committee at each study site. There were no protocol amendments for this study.
: Neeltje Steeghs provided consultation or attended advisory boards for Boehringer Ingelheim and Ellipses Pharma and also received research grants for the institute from AB Science, Abbvie, Actuate Therapeutics, ADCtherapeutics, Amgen, Array, Ascendis Pharma, Astex, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, BridgeBio, Bristol-Myers Squibb, Cantargia, Celgene, CellCentric, Cresecendo, Cytovation, Deciphera, Eli Lilly, Exelixis, Genentech, Genmab, Gilead, GlaxoSmithKline, Incyte, InteRNA, Janssen/Johnson&Johnson, Kinate, Merck, Merck Sharp & Dohme, Merus, Molecular Partners, Novartis, Numab, Pfizer, Pierre Fabre, Regeneron, Roche, Sanofi, Seattle Genetics, Servier, Taiho, (outside the submitted work), and Takeda. Vickie Lu and Xiaofei Zhou are employees of Takeda. John Redman was a consultant to Takeda and served as the Global Clinical Leader during the TAK-931 program. Melinda Pruis and Carla van Herpen declare no potential conflicts of interest.