Chen, Joseph http://orcid.org/0000-0002-5998-7765
O’Gorman, Melissa T.
James, Lee P.
Klamerus, Karen J.
Mugundu, Ganesh
Pithavala, Yazdi K.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics of Lorlatinib After Single and Multiple Dosing in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: Results from a Global Phase I/II Study
https://doi.org/10.1007/s40262-021-01015-z
Funding for this research was provided by:
Pfizer Inc.
Article History
Accepted: 10 March 2021
First Online: 3 May 2021
Declarations
:
: This study was sponsored by Pfizer Inc.
: Joseph Chen, Yazdi K. Pithavala, and Melissa T. O’Gorman are employees of Pfizer Inc. and may own stock or stock options in Pfizer. Lee P. James, Karen J. Klamerus, and Ganesh Mugundu are former employees of Pfizer Inc. and may own stock or stock options in Pfizer.
: Upon request, and subject to certain criteria, conditions, and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the US and/or EU, or (2) in programs that have been terminated (i.e. development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization Good Clinical Practice Guidelines, and all local regulatory requirements were followed.
: Each patient provided written informed consent before participation. Each investigator received prospective approval of the study protocol, protocol amendments, informed consent documents, and all other relevant documents from their individual institution’s review board or ethics committee.
: JC, LPJ, KK, GM, YKP designed and performed the research. MTO analyzed the data. JC and YKP interpreted the data. All authors drafted the manuscript or revised it critically for important intellectual content and approved the version to be submitted. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.