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Policy on Registration of Studies, Public Disclosure of Results, and Authorship

1. Purpose

As a research-based pharmaceutical company, Pfizer recognizes that the registration of clinical trials/clinical studies and the availability of clinical study results are important to the medical profession, to study subjects, and to the public. This policy, describes Pfizer standards for (1) registration of Pfizer-sponsored studies; (2) disclosure of results from Pfizer-sponsored studies (e.g., in scientific articles, posters, abstracts, and in online results databases); (3) authorship of publications about those results; and (4) investigator access to clinical data relevant to publications of study results. 

2. Scope

This policy applies to Pfizer colleagues and, as appropriate, to those parties with whom Pfizer contracts (e.g., Functional Service Providers [FSPs], Contract Research Organizations [CROs] or consultants) who are involved in the activities described in this policy.

This policy applies to studies sponsored by Pfizer human health organizations, including non-interventional studies with prospective data collection.  Such studies generally, but not always, involve the use of a Pfizer product.

Study registration and disclosure of study results are the responsibility of the sponsor. Investigator-Initiated Research (IIR) studies are out of scope for this policy as such studies are not sponsored by Pfizer. Pfizer’s IIR contracts state that it is Pfizer’s expectation that studies are registered and results are disclosed at appropriate times.

When Pfizer has an alliance with another company for the development and/or marketing of a product, Pfizer and the other company agree which party has responsibility for public disclosure.  When Pfizer has responsibility for management of public disclosure of study information, Pfizer’s policy and processes are followed.

This policy addresses:

• Registration of studies
• Communication of study results by Pfizer and investigators
• Authorship of study publications
• Investigator access to study data

This policy does not affect Pfizer's reporting requirements to regulatory agencies. It also does not address internal review and approval of publications by Pfizer researchers.

3. Policy

Pfizer recognizes that there are public health benefits associated with making study information widely available to health care professionals and subjects through clinical study registries and results databases.

Pfizer is committed to publicly registering Pfizer-sponsored Phase 1-4 interventional studies in patients (including Phase 1 studies conducted in patients) as well as registering Pfizer-sponsored Phase 4 non-interventional studies with prospective data collection, regardless of the condition studied or study location. Pfizer may also choose to publicly register other Pfizer-sponsored studies at its discretion. Studies are registered prior to patient enrollment.

Pfizer is committed to the communication of results of all registered studies, regardless of outcome.  Additionally, Pfizer discloses the results of studies that are not registered if the study was included in an approved marketing authorization application or the study results have scientific or medical importance.  For studies involving the use of a Pfizer product, the timing of Pfizer’s communication of study results typically follows the product’s approval in any country.

3.1 Registration of Clinical Studies

Pfizer registers Pfizer-sponsored Phase 1-4 interventional studies conducted in patients as well as Pfizer-sponsored Phase 4 non-interventional studies with prospective data collection on the www.clinicaltrials.gov Web site (ClinicalTrials.gov). Pfizer’s study registration commitment meets and exceeds the Food and Drug Administration Modernization Act (FDAMA) Section 113, which requires registration of Phase 2-4 efficacy studies involving serious or life-threatening conditions as well as the recommendations of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Joint Position on the Disclosure of Clinical Trial Information (January 2005), which recommends registration of confirmatory studies. Pfizer may also choose to register additional studies (e.g., Phase 1 studies in healthy volunteers) at Pfizer’s discretion.

In rare instances, during the initial posting of study information on ClinicalTrials.gov, Pfizer may not complete certain data fields if doing so discloses commercially sensitive information. Such commercially sensitive information generally involves the primary and secondary endpoints, the number of subjects in the study, the name of the investigational product, or certain elements of the official scientific title of the study.  Delaying the release of information due to commercial sensitivity occurs only when deemed necessary and must be reviewed by Pfizer management on a case-by-case basis.  Moreover, any commercially sensitive information that is temporarily delayed from the registration on ClinicalTrials.gov must be added, at the very latest, upon posting of the study results on the www.clinicalstudyresults.org Web site (ClinicalStudyResults.org).

3.2 Communication of Results by Pfizer

Pfizer is committed to publicly disclosing, on ClinicalStudyResults.org, the results of all studies registered on ClinicalTrials.gov.  Pfizer also discloses the results of studies that are not registered if the study was included in an approved marketing authorization application, or the study results have scientific or medical importance.  For studies involving the use of a Pfizer product, the timing of Pfizer’s communication of the study results typically follows the product’s approval in any country.

Pfizer discloses the results of all registered studies conducted before the product was approved or development was discontinued.  For registered studies involving an already approved product or that do not involve a Pfizer product, Pfizer discloses the results within one year after study completion.  Pfizer reserves the right not to release interim or preliminary study results and normally posts results only after the final study report is available.

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

3.3 Publications by Investigators

Pfizer supports publication by investigators of the results of all Pfizer-sponsored studies that have been registered, or are of scientific or medical importance.  For multi-site studies, a publication that includes the overall study results at all sites is preferred.  Pfizer generally asks its investigators to agree that the first publication from a multi-site study will reflect the overall study results.  Analyses based on single-site data usually have significant statistical limitations and generally do not provide meaningful information for health care professionals or patients.  However, investigators are free to publish individual site results that they deem clinically meaningful after publication of the overall results or one year after study completion at all sites, whichever occurs first.  

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 otherwise publicly disclosed.  Pfizer commits to respond in a timely manner and not suppress or veto publications or other appropriate public disclosures of study results.  In rare cases, it may be necessary to delay publication or other public disclosures for a short time to protect intellectual property.  Upon request by an investigator-author, Pfizer provides a protocol, protocol synopsis, 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.

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

3.4 Authorship of Study Publications

Pfizer supports the authorship criteria established by the International Committee of Medical Journal Editors (ICMJE) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials & 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.

It is Pfizer policy that only those individuals who meet all of the ICMJE criteria should be named as authors on publications of Pfizer-sponsored studies. 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. Thus, if a Pfizer employee meets the criteria for authorship, he/she should be listed as an author.

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.

The determination of who obtains authorship credit lies solely with the potential authors, in accordance with ICMJE guidelines. When feasible, 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.

3.5 Investigator Access to Data and Review of Results

Generally, study databases are only made available to regulatory authorities. Individual investigators already have access to their study subjects’ data. 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-site studies, Pfizer makes summary results of the overall study available to all participating investigators. In addition, Pfizer permits any investigator who participated in the conduct of a multi-site study to review relevant statistical tables, figures, and reports for the entire study at a designated Pfizer facility or other mutually agreeable location. Pfizer also responds to reasonable requests from investigators for additional analyses of multi-site study results.

4. Responsibilities

Study teams are responsible for designing and implementing all clinical research within the scope of this policy in accordance with this policy.  Exceptions to this policy require approval of senior management and Legal.

5.Process

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6. Appendices

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