von Mehren, Margaret http://orcid.org/0000-0001-6158-890X
Heinrich, Michael C.
Shi, Hongliang
Iannazzo, Sergio
Mankoski, Raymond
Dimitrijević, Saša
Hoehn, Gerard
Chiroli, Silvia
George, Suzanne
Funding for this research was provided by:
Blueprint Medicines Corporation (N/A)
Article History
Received: 9 October 2020
Accepted: 4 March 2021
First Online: 19 March 2021
Declarations
:
: The protocol of the NAVIGATOR trial was approved by the institutional review board or independent ethics committee of each study center. The study was conducted in accordance with the International Conference on Harmonisation/Good Clinical Practice Guidelines, the ethical principles of the Declaration of Helsinki, and applicable national and local regulatory requirements. All patients provided written informed consent.Study 1002 was conducted at sites that granted institutional review board approval and in full compliance with the principles of the Declaration of Helsinki. Due to the retrospective nature of the study, ethical considerations were limited to patient confidentiality and privacy. A list of NAVIGATOR and Study 1002 institutional review boards or independent ethics committees of each study site is provided in supplementary Tables InternalRef removedandInternalRef removed, respectively. Since <i>PDGFRA</i>-driven GIST is rare, de-identification of data may not have provided full protection of patient confidentiality. Therefore, a limited data set approach was used to allow disclosure of protected health information as defined by the Health Insurance Portability and Accountability Act for research purposes. Individual patient consent was not obtained due to the non-interventional and retrospective nature of the study.
: The manuscript does not contain data from any individual person, and so consent for publication is not applicable for inclusion in this report.
: Dr. von Mehren reported receiving other support from Arog Pharmaceuticals and Deciphera Pharmaceuticals outside the submitted work and other support from Blueprint Medicines Corporation during the conduct of the study. Dr. von Mehren and Dr. Heinrich both report funding from GIST Cancer Research Fund and the Jonathan David Foundation. Dr. Heinrich reports grants and personal fees from Blueprint Medicines Corporation, and a US Veterans Administration Merit Review Grant (I01 BX000338, MCH) during the conduct of the study, grants and personal fees from Deciphera Pharmaceuticals, outside the submitted work, other from MolecularMD, during the conduct of the study and personal fees and other from Novartis; in addition, Dr. Heinrich has a patent “Treatment of Gastrointestinal Stromal Tumors” licensed to Novartis, and having a patent “Activating Mutations of PDGFRA” issued. At the time of development of this study, Sergio Iannazzo was employed by Hetegy, a health economics consulting company which received consulting fees from Blueprint Medicines Corporation. Sergio Iannazzo is currently an employee and shareholder of Blueprint Medicines Corporation. Dr. George reports personal fees from Bayer, Blueprint Medicines Corporation, Daiichi Sankyo, Deciphera Pharmaceuticals, Eli Lilly, Exelixis, MORE Health, Research to Practice and UpToDate, and grants from ARIAD, Bayer, Blueprint Medicines Corporation, Deciphera Pharmaceuticals, Novartis, Pfizer, outside the submitted work; stock in Abbott Laboratories and Allergan; expert testimony for Bayer; relationship with Research to Practice; and royalties from UpToDate. Hongliang Shi, Raymond Mankoski, Saša Dimitrijević, Gerard Hoehn and Silvia Chiroli are employees and shareholders of Blueprint Medicines Corporation.