Arpino, Grazia
De Angelis, Carmine
Gerratana, Lorenzo
Lambertini, Matteo
Igidbashian, Sarah
Gramigna, Rosanna
Guillaume, Xavier
Funding for this research was provided by:
AstraZeneca and Daiichi Sankyo
Article History
Received: 18 December 2024
Accepted: 12 May 2025
First Online: 22 May 2025
Declarations
:
: This was an anonymized online survey with no product tested, no impact on the patient’s care, no abstraction of medical information for patient records. The survey aimed to collect the patients’ opinions and attitudes. The study questionnaire was self-completed by the participants at a specific time point, recruited outside their place of care. The study did not lead to a change in behavior or medical observation, nor influence treatment. Health information collected from the participants was unverifiable and based on their recall. There was no specific product studied. Furthermore, no direct personal identifying information was collected and analyzed that could allow the re-identification of patients (e.g., no information like name, surname was asked to the patients nor patients’ identity mentioned on the study questionnaire). Therefore, the study is considered as anonymized for the Sponsor and Oracle Life Sciences. Finally, participation in the survey was entirely voluntary and participants could end their participation at any time of the survey, if they felt uncomfortable with the survey questions.Since Ethical Committees in Italy are affiliated with hospitals/research centers and only review studies conducted at their respective sites (Legislative Decree No. 211 of 2003), our study was not eligible for EC review as it did not involve any specific site or hospital [].The study was conducted in accordance with the Declaration of Helsinki. All participants provided informed consent prior to taking part in the study. Participants received a comprehensive information text (see Supplemental Methods – Survey) that explained the purpose of the study, their rights, and details on data collection and confidentiality. Given the direct-to-patient approach, a traditional signed consent form was not used. Instead, an opt-in procedure was implemented, requiring participants aged 18 years and older to actively indicate their consent by ticking a checkbox confirming they had read and accepted the study information and participation conditions. Access to the survey was only granted after this opt-in confirmation, which served as documented evidence of informed consent. The Participant Information Leaflet (PIL) emphasized the voluntary nature of participation, confidentiality of collected data, the right to withdraw at any time, and provided contact details for questions or concerns.
: Not applicable.
: Matteo Lambertini: advisory role for Roche, Lilly, Novartis, Astrazeneca, Pfizer, Seagen, Gilead, MSD, Exact Sciences, Pierre Fabre, Menarini; speaker honoraria from Roche, Lilly, Novartis, Pfizer, Sandoz, Libbs, Daiichi Sankyo, Takeda, Menarini, AstraZeneca; travel Grants from Gilead, Daiichi Sankyo, Roche; research funding (to the Institution) from Gilead all outside the submitted work. Carmine De Angelis: advisory role for Roche, Lilly, Novartis, AstraZeneca, Pfizer, Gilead, Daiichi Sankyo and GSK and speaker honoraria from Roche, Lilly, Novartis, Pfizer, and GSK; Travel Grants from Gilead and research support (to the Institution) from Novartis, GILEAD and Daiichi Sankyo all outside the submitted work. Lorenzo Gerratana: advisory role for AstraZeneca, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Incyte, Novartis, Pfizer, Merck Sharp & Dohme, Menarini Stemline, Abbvie; travel Grants from Menarini Stemline, Novartis, Gilead all outside the submitted work.