Lambert, Jérémy
Marrel, Alexia
D’Angelo, Sandra P.
Burgess, Melissa A.
Chmielowski, Bartosz
Fazio, Nicola
Gambichler, Thilo
Grob, Jean-Jacques
Lebbé, Céleste
Robert, Caroline
Russell, Jeffrey
Güzel, Gülseren
Bharmal, Murtuza
Funding for this research was provided by:
Merck KGaA, Darmstadt, Germany
Pfizer
Article History
First Online: 30 May 2020
Compliance with Ethical Standards
:
: This study was funded by an alliance between Merck KGaA, Darmstadt, Germany and Pfizer.
: Jérémy Lambert and Alexia Marrel are employees of ICON, and were paid consultancy fees by Merck KGaA. Murtuza Bharmal is an employee of EMD Serono, a business of Merck KGaA, Darmstadt, Germany. Melissa A. Burgess reports serving as a consultant or advisor for EMD Serono and Immune Design. Nicola Fazio provided speaker and advisory board services for AAA Pharma, Ipsen, Merck KGaA, Merck Sharp & Dohme, Novartis and Pfizer. Thilo Gambichler received speakers and/or advisory board honoraria from Abbvie, Almirall, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Roche, Pfizer, Pierre Fabre and Sanofi-Genzyme. Jean-Jacques Grob has received honoraria from Amgen, Bristol-Myers Squibb, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre, Roche and Sanofi; reports serving as a consultant or advisor for Amgen, Brystol-Myers Squibb, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre, Roche and Sanofi; is a member of a speakers’ bureau for Novartis; and has received reimbursement for travel and accommodations expenses from Brystol-Myers Squibb, Merck Sharp & Dohme, Novartis and Pierre Fabre. Céleste Lebbé has received honoraria from Amgen, Bristol-Myers Squibb, Incyte, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre and Roche; reports serving as a consultant or advisor for Amgen, Bristol-Myers Squibb, Merck Sharpe & Dohme, Novartis and Roche; is a member of a speakers’ bureau for Amgen, Bristol-Myers Squibb, Novartis and Roche; has received research funding from Bristol-Myers Squibb and Roche; has received reimbursement for travel and accommodation expenses from Bristol-Myers Squibb; and has other relationships with Avantis Medical Systems. Jeffrey Russell is an employee of Immunocore. Gülseren Güzel is an employee of Merck KGaA. Sandra P. D’Angelo reports serving as a consultant or advisor for Amgen, EMD Serono, GlaxoSmithKline, Immune Design, Incyte, Merck & Co. and Nektar; received research grants from Amgen, Bristol-Myers Squibb, Deciphera, EMD Serono, Incyte, Merck & Co. and Nektar; and received reimbursement for travel and accommodation expenses from Adaptimmune, EMD Serono and Nektar. Caroline Robert reports advisory roles for BMS, Piere Fabre, Novartis and Amgen and reports ownership of equity from Merck KGaA, Roche, MSD, Sanofi, Biotherma and Ultimovacs. Bartosz Chmielowski has no conflict of interest to declare.
: The clinical trial protocol, including sections related to the qualitative interviews, was approved by all relevant independent ethics committees and institutional review boards and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.
: All participants provided written informed consent prior to any study-related procedures. Patients who agreed to be interviewed indicated their willingness to participate within the informed consent form.
: For all new products or new indications approved in both the European Union and the USA after 1 January, 2014, Merck KGaA, Darmstadt, Germany will share patient-level and study-level data after deidentification, as well as redacted study protocols and clinical study reports from clinical trials in patients. These data will be shared with qualified scientific and medical researchers, upon a researcher’s request, as necessary for conducting legitimate research. Such requests must be submitted in writing to the company’s data sharing portal. More information can be found at ExternalRef removed. Where Merck KGaA has a co-research, co-development, or co-marketing/co-promotion agreement or where the product has been out-licensed, it is recognised that the responsibility for disclosure may be dependent on the agreement between parties. Under these circumstances, Merck KGaA will endeavour to gain agreement to share data in response to requests.