Ethics approval and consent to participate
The research was conducted ethically in accordance with the World Medical Association
Declaration of Helsinki International Conference on Harmonisation Good Clinical Practice, patient privacy requirements, and ethical principles outlined in the Declaration of Helsinki 2018. The protocol and ICF were reviewed and approved in Singapore by “Singhealth Centralised Institutional Review Board (CIRB)”, and also by properly constituted Institutional Review Boards/Independent Ethics Committees (IRB/IEC) of 34 other participating centres according to local regulations before the start of the study. Health authority approval was obtained per local regulations. Patients provided informed consent according to local requirements.
Consent for publication: Not Applicable.
Availability of data and materials:
“Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.”
ME reports honoraria from Novartis, Pfizer, Astellas, Janssen, BMS, MSD, Amgen, Nobel, Astra-Zeneca, Roche, and Gen Ilac outside the submitted work; TH is a member of advisory board, consultant and speaker for Hoffman la Roche, Novartis, Astra Zeneca, MSD, Amgen, Pfizer, Janssen Cilag, Merck Serono, and Mundi Pharma; BK reports clinical trials, satellite symposiums, congress and journal support from Roche, Pfizer, Novartis, Merck, Serono, MSD, Amgen, Bayer, Gen, BMS, and AstraZeneca; RK reports grants and personal fees from Eisai, Ipsen, BMS, MSD, Pfizer, Astellas, Johnson & Johnson, Amgen, Sanofi, and Mundipharma outside the submitted work; Sara Ingles is employed by Aerotek and contracted by Novartis AG; KS is an employee of Novartis and owner of stock options; CC is an employee of Novartis AG; BB, PD, LC, YFW, CSL, and HJC have declared that they have no competing interests.
The PARACHUTE study was sponsored by Novartis Pharmaceuticals Corporation; pazopanib is an asset
of Novartis AG as of 1 March 2015.
ME: Conceptualization, methodology, writing and review & editing of the manuscript; BB: Investigation and review of the manuscript; PD: Investigation and review of the manuscript; LC: Investigation and review of the manuscript; YFW: Investigation and review of the manuscript; TH: Investigation and review of the manuscript; CSL: Investigation and review of the manuscript; BK: Investigation and review of the manuscript; HJC: Investigation and review of the manuscript; CC: Data curation, formal analysis, validation, visualization, review of the manuscript; SI: Project administration data curation, formal analysis, validation; visualization, review of the manuscript; KS: Conceptualization, validation, visualization, review of the manuscript; RK: Conceptualization, methodology, writing and review & editing of the manuscript.
Medical writing and editorial support was provided by Anuradha Bandaru of Novartis Healthcare Pvt Ltd (Hyderabad, India).