Anthenelli, Robert M.
Gaffney, Michael
Benowitz, Neal L.
West, Robert
McRae, Thomas
Russ, Cristina
Lawrence, David
St. Aubin, Lisa
Krishen, Alok
Evins, A. Eden
Article History
Received: 12 March 2018
Revised: 5 September 2018
Accepted: 11 January 2019
First Online: 7 March 2019
Compliance with Ethical Standards
: Upon request, and subject to certain criteria, conditions and exceptions (see https://ExternalRef removed 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 USA 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.
: RMA reports his university receiving grants from Alkermes and Pfizer and providing consulting and/or advisory board services to Arena Pharmaceuticals, Cerecor, Pfizer, and US WorldMeds. RMA’s writing of this manuscript was supported, in part, by National Institute on Alcohol Abuse and Alcoholism Grant no. U01 AA013641, and National Institute on Drug Abuse (NIDA) Grant no. UO1 DA041731, and NIDA/Veterans Affairs Cooperative Study no. 1033. NLB reports consulting and/or advisory board services to GlaxoSmithKline, Pfizer, and Achieve Life Sciences and is a paid expert witness in litigation against tobacco companies. RW reports grants from Johnson & Johnson and Pfizer and personal fees for consulting and/or advisory board services to GlaxoSmithKline, Johnson & Johnson, and Pfizer. RW’s writing of this manuscript was supported, in part, by Cancer Research United Kingdom. AEE reports grants from Forum Pharmaceuticals and Pfizer and personal fees for advisory board services from Pfizer, Reckitt Benckiser, and Alkermes. AEE’s writing of the manuscript was supported by a NIDA Career Award in Patient-Oriented Research, K24 DA030443. MG, TM, CR, DL, and LSA are employees and stockholders of Pfizer. AK is a PAREXEL employee working on behalf of GlaxoSmithKline.
: The opinions expressed in this article are those of the authors and do not necessarily reflect the views of their employers.