Public Disclosure and Authorship

1. Purpose

Pfizer recognizes the importance of making clinical studies and clinical study results available to the medical profession, to potential study subjects, and to the public. This policy reflects federal and state requirements as well as international standards and Pfizer policies regarding public disclosure of clinical studies.

2. Scope

This policy applies to Pfizer colleagues and, to those parties with whom Pfizer contracts (e.g., Contract Research Organizations [CROs]/vendors or consultants) who are involved in the activities described in this policy including:

• Registration of Pfizer sponsored studies
• Posting of study results by Pfizer
• Authorship of study publications
• Investigator access to study data

This policy applies to Pfizer-sponsored studies in human subjects, including interventional and non-interventional studies.

This policy does not cover Investigator-Initiated Research (IIR) studies as they are not sponsored by Pfizer. Pfizer encourages IIR grant recipients to register their IIR studies and to post results.

When Pfizer has an alliance with another company for the development and/or marketing of a product, Pfizer and the other company agree, in writing, as to which party has responsibility for all processes related to registration of studies and posting of results; however Pfizer retains responsibility for registration and posting of results for all studies sponsored by Pfizer (e.g., when Pfizer holds the US Investigational New Drug (IND) Application or other regulatory authorization for the study). This policy applies to all such studies, sponsored by Pfizer or where Pfizer has been vested with responsibility for management of registration and posting of results.

3. Policy

Pfizer-sponsored studies are registered and results are posted, in accordance with this policy and related policies and procedures. A summary of the effective dates for registration of studies and posting of study results is detailed in Section 5 below. Pfizer support for publications, criteria for authorship, and investigator access to study data are also described below.

Pfizer marketing and sales personnel may not be involved in the preparation of study results or the preparation, planning or content development for publications.

3.1 Registration of Clinical Studies

Pfizer registers all Pfizer-sponsored studies that involve the use of a Pfizer drug, biologic or device and non-interventional studies where the data collection is defined prior to enrollment (i.e., de novo prospective data collection). These studies are registered on the www.clinicaltrials.gov website (ClinicalTrials.gov).

3.2 Posting of Study Results by Pfizer

The results of all studies registered on ClinicalTrials.gov are posted on ClinicalStudyResults.org. Additionally, Pfizer posts Basic Results for studies completed after 27 September 2007 to ClinicalTrials.gov.

Pfizer posts results according to the timelines described below:

• Post-approval studies: For studies involving products already approved for sale in any country, Pfizer posts results within one year after the protocol-defined study completion date.
• Pre-approval studies: For studies completed prior to submission of the initial marketing authorization application in the US (i.e., a US New Drug Application [NDA]), Pfizer posts Basic Results within 30 days of the first approval/clearance in the US and a Pharmaceutical Research and Manufacturers of America (PhRMA) website synopsis (PWS) prior to the commercial sale of the product. For studies completed prior to submission of the initial marketing authorization application, submitted to a country other than the US, Pfizer posts a PWS within one year of the first approval/clearance.
• Discontinued Programs: The results of any study registered on ClinicalTrials.gov involving an unapproved product for which development of the compound is discontinued, are posted within one year of the date of discontinuation of development of the compound.

In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and complete manner and are reported regardless of the outcome of the study or the country in which the study was conducted.

3.3 Publications

Pfizer supports publication by investigators of the results of Pfizer-sponsored studies conducted in patients or which have scientific or medical importance. Pfizer provides compensation to investigators for their work in conducting these studies but does not compensate for authorship of a primary publication about the results of the study.

In multi-center studies, analyses of data from a single-center usually have significant statistical limitations. For this reason, Pfizer supports having the overall study results from a multi-center study included in the first publication from the study. Investigators are free to publish individual center results that they deem clinically meaningful after publication of the overall results or one year after study completion (e.g., last subject's last visit) at all sites, whichever occurs first.

All authors of a Pfizer-supported publication are provided access to relevant statistical tables, figures and reports necessary to support the planned publication. Upon request by an author, Pfizer provides a protocol, and/or the pre-specified plan for data analysis to a medical journal, provided that the journal agrees to keep such information confidential and return it to Pfizer after publication of the article.

Pfizer reserves the right to review any manuscripts, presentations, abstracts or other public disclosures relating to Pfizer-sponsored studies or that utilize Pfizer data before they are submitted for publication or are otherwise publicly disclosed. Pfizer commits to respond in a timely manner to such requests for review. In rare cases, it may be necessary to delay publication or other public disclosures for a short time to protect intellectual property. However, Pfizer will not suppress or veto publications or other appropriate public disclosures of study results.

When differences of opinion or interpretation of data exist, Pfizer will assist the authors to resolve the differences through scientific discussion and with deference toward ensuring patient welfare.

3.4 Authorship of Medical Publications

Pfizer supports the authorship criteria established by the International Committee of Medical Journal Editors (ICMJE) and the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. According to these guidelines, authorship credit is based only on substantial contribution to:

• Concept and design, or acquisition of data, or analysis and interpretation of data; and
• Drafting or revising the manuscript for important intellectual content; and
• Approval of the final version to be published.

Pursuant to the ICMJE criteria, general supervision of the research group that is conducting or supervising a project is not sufficient for authorship. Similarly, participation solely in the acquisition of funding or collection of data does not justify authorship. Any part of an article critical to its major conclusions must be the responsibility of at least one author.

Only those individuals who meet all of the ICMJE criteria should be named as authors on medical publications. All those who deserve authorship based on these criteria should be named in the byline and those who do not should be acknowledged elsewhere, if appropriate. These criteria apply to all researchers involved in the study publication. If a Pfizer employee meets the criteria for authorship, they should be listed as an author.

The determination of who obtains authorship credit lies solely with the potential authors, in accordance with ICMJE guidelines. Authorship should be identified at the outset of a study, as this may help to determine issues of access to data and communication, as well as to avoid potential conflicts later.

Where Pfizer hires technical support to help analyze and interpret data or prepare manuscripts and presentations, those contracted service providers must work under the direction of the authors. Technical writers must be recognized in resulting publications, either as a named author, a contributor, or in the acknowledgments, as appropriate to reflect their contribution.

All authors, in accordance with the relevant journal guidelines, must disclose in the manuscript or to the journal as part of the submission, relationships that could be viewed as presenting a conflict of interest. Authors must also acknowledge individuals who provide editorial support and disclose the funding source. For Pfizer-sponsored studies the fact that the study was funded by Pfizer must be disclosed.

3.5 Investigator Access to Data and Review of Results

On request, Pfizer will provide any investigator with the randomization code for his/her study subjects after completion of the study at all study sites. For multi-center studies, summary results of the overall study are available to all participating investigators. In addition, Pfizer permits any investigator who participated in the conduct of a multi-center study to review relevant statistical tables, figures, and reports for the entire study at a designated Pfizer facility or other mutually agreeable location. Pfizer will consider reasonable requests from investigators for additional analyses of multi-center study results. Study databases are made available to regulatory authorities and data monitoring committees.

4. Responsibilities

Study teams are responsible for designing and implementing all clinical research within the scope of this policy in accordance with this policy. Exception to this policy requires written approval of senior management and Legal and in accordance with the SOP waiver process set forth in the ADM01 SOP on Standard Operating Procedure Development and Management, Including SOP Training, Waivers, and Deviations.

5. Process

History of Pfizer's Public Disclosure Policy

May 2002
Pfizer begins registering Pfizer-sponsored studies for serious or life-threatening conditions as described by the 1997 FDA Modernization Act (FDAMA) on ClinicalTrials.gov.

October 2004
Pfizer begins posting results to ClinicalStudyResults.org for Pfizer-sponsored confirmatory studies that completed on or after 01 October 2002.

July 2005
Pfizer expands its registration policy to include all Pfizer-sponsored confirmatory studies.

September 2005
Pfizer begins posting the results of all studies registered on ClinicalTrials.gov to the PhRMA website ClinicalStudyResults.org in addition to Pfizer-sponsored confirmatory studies that completed on or after 01 October 2002.

September 2006
Pfizer expands its disclosure policy to include the registration and posting of results for all Pfizer-sponsored Phase 2 through 4 interventional studies.

January 2007
Pfizer expands its disclosure policy to include the registration and posting of results for all Pfizer-sponsored clinical studies conducted in patients as well as Phase 4 non-interventional studies with prospective data collection.

July 2008
Pfizer expands its disclosure policy to include the registration and posting of results for all Pfizer-sponsored Phase 1 through 4 studies involving a Pfizer drug in both patients and healthy volunteers, as well as non-interventional studies where data collection is defined prior to enrollment (i.e., de novo prospective data collection).

6. Appendices

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