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Authors
Zhang, Jian
Yang, Nong
Ji, Dongmei
Shen, Weina
Li, Wenhua
Han, Rubing
Wang, Ning
Tao, Haoxun
Chapman, Sonya C.
Sykes, Amanda K.
Zhang, Wanli
Hu, Xichun
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Funding
Funding for this research was provided by:
Eli Lilly and Company
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Article History
Accepted: 29 December 2020
First Online: 25 January 2021
Declarations
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: This study was sponsored by Eli Lilly and Company, manufacturer/licensee of abemaciclib.
: Rubing Han, Ning Wang, Haoxun Tao, Sonya C. Chapman, Amanda K. Sykes, and Wanli Zhang are employees and minor shareholders of Eli Lilly and Company. The remaining authors have no conflicts of interest to declare.
: Written approval was provided by the Institutional Review Board, and the study was conducted in accordance with international ethics guidelines, including the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practices Guideline [E6], and applicable laws and regulations.
: Informed consent was obtained from each patient before any protocol procedures or administration of study drug.
: N/A.
: Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data access should comply with local laws and regulations. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at .
: N/A.
: The funder of the study (Eli Lilly and Company) had a role in study design, data collection, data analysis, data interpretation (in collaboration with all authors), and writing of the report. The corresponding author had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
