Public Disclosure and Authorship
1. Purpose & Scope
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.
The purpose of this clinical and medical controlled document (CMCD) policy is to describe the requirements for:
- Registration of Pfizer-sponsored studies.
- Posting of study results by Pfizer.
- Press release of Phase 3 (including Phase 3B) and certain Phase 4 clinical study data.
- Publication of Pfizer-sponsored studies.
- Authorship of medical publications.
- Investigator access to study data.
The term policy will be used throughout the remainder of this policy.
This policy applies to:
- Pfizer colleagues who are involved in activities related to the policy, as well as to those parties with whom Pfizer contracts (e.g., contract research organizations, vendors or consultants) to perform such activities, unless Pfizer has agreed that such parties may follow their own processes with respect to these activities.
- Research units and business units (BUs) as well as the functional lines responsible for clinical and medical activities including research, development, regulatory, pharmacovigilance and product quality.
- Unless otherwise indicated below, Pfizer-sponsored studies in human subjects, including interventional and non-interventional (NI) studies.
- Unless otherwise indicated below, an alliance with another company for the development and/or marketing of a product. Pfizer and the other company agree 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 United States [US] investigational new drug 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.
This policy does not apply to:
- 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.
- Pfizer Nutritional studies.
2. Policy Statements
Pfizer Commercial (i.e., marketing and sales) personnel must not be involved in the preparation of study results or the preparation, planning or content development for publications, with the exception of an optional annual meeting with the publication team where marketing may provide non-binding suggestions to the publication team.
Exceptions to this policy must comply with the CMCD standard operating procedure (SOP) deviation process described in ADM01-GSOP SOP Model for Clinical and Medical Controlled Documents.
2.1. Registration of Clinical Studies
Note: Sections 2.1 and 2.2 do not apply to studies registered on databases other than the www.clinicaltrials.gov website (hereafter referred to as ClinicalTrials.gov). However, study teams are strongly encouraged to ensure study registration and results data are consistent with the information posted on ClinicalTrials.gov.
Pfizer registers all Pfizer-sponsored interventional studies in human subjects on ClinicalTrials.gov that:
- involve the use of a Pfizer product and
- evaluate the safety and/or efficacy of a Pfizer product.
2.2. Posting of Study Results by Pfizer
Regardless of the geographical location in which the study was conducted, Pfizer posts Basic Results on Clinicaltrials.gov for Pfizer-sponsored interventional studies conducted in patients that evaluate the safety and/or efficacy of a Pfizer product.
Pfizer posts results according to the following timelines:
- Post-approval studies: For studies involving products already approved in the US, results are posted within one year of the primary completion date (PCD). For studies involving products already approved for sale in countries outside the US, Pfizer posts results within one year after last subject last visit (LSLV).
- Pre-approval studies: For studies completed prior to submission of the initial marketing authorization application (MAA) (i.e., a US New Drug Application), Pfizer posts Basic Results within 30 calendar days of the first marketing authorization approval in the US. For studies completed prior to submission of the initial MAA, submitted to a country other than the US, Pfizer posts results 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 (if there are no plans for outlicensing or within two years if outlicensing plans have not completed).
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.
2.3. Public Disclosure of Phase 3 (including Phase 3B) and Certain Phase 4 Clinical Study Data
Note: Section 2.3 does not apply to:
- Clinical studies conducted by the Pfizer Consumer Healthcare BU.
- NI studies.
- Clinical studies where a product is in co-development with a partner. Teams are nonetheless encouraged to communicate the spirit and intent of this policy to development partners, and to make reasonable efforts to obtain endorsement. In cases where mutual agreement regarding this policy is not possible, teams must document the alternative policy that will govern disclosure with the specific partner.
Pfizer will issue press releases to disclose results of the primary endpoints of Phase 3 (including Phase 3B) and certain Phase 4 studies (i.e., those with primary endpoints referring to a productýs efficacy and/or safety). This is limited to hypothesis-testing studies (i.e., those which will have a Yes/No answer to the question of whether the primary endpoint was met). The press releases will include the factual final outcome of all study results that are pre-defined in the protocol as primary endpoints for efficacy and safety. This may be accompanied, as appropriate, with background and context deemed necessary or desirable to deliver an accurate, complete and informed communication. Additional details of the results may be provided at the discretion of the sponsoring BU. If a decision is made to include secondary endpoints in the disclosure, then all of the secondary endpoints must be included. The press release is based on those study tables that support the disclosed endpoint results. The press release must not be issued until these tables are finalized and quality control checked.
The policy within this section applies whether or not the study results are considered material and regardless of the final outcome, whether or not favorable.
Interim study results are required to be disclosed in a press release only if (a) they result in the discontinuation of a Phase 3 clinical study, or (b) they are considered material and prompt disclosure is required by law (e.g., if they significantly alter the benefit-risk profile of a product). Pfizer may choose to issue press releases disclosing interim study results even when not required, but potential inconsistencies in application (e.g., disclosing only favorable results) must be avoided.
Press releases are issued within a speedy and reasonable timeframe. The need to inform regulators must to be taken into consideration, particularly when the disclosure involves pharmacovigilance issues or changes to the benefit-risk profile of an approved product or where the study concerned is a post-approval commitment to regulators. The target timeframe is dissemination of study results as soon as is practical, with the specific goal not to exceed 4 weeks after the availability of the results of the primary endpoints. Exceptions of up to 8 weeks from the availability of the results of the primary endpoints are permitted with the approval of the BU President and BU Chief Counsel. If a timeframe of longer than 8 weeks is needed or an exception not to issue a press release or any other exception is sought, endorsement by the Pfizer Executive Leadership Team, or by any subset thereof determined by the Chief Executive Officer, is required.
Notwithstanding the policy within this section, if the study results (regardless of phase) are considered material, a press release may have to be issued as soon as practicable after the availability of the results of the primary endpoints.
Before a press release is issued, study results cannot be shared with third parties (other than regulators and development partners, as necessary) unless they are bound by confidentiality obligations. However, study results may be shared with external governance (if any) as well as study investigators and study subjects, with a prompt press release to follow, if it is deemed necessary or desirable in the interest of subject management.
2.4. Publication of Pfizer-Sponsored Studies
For all Pfizer-sponsored interventional clinical studies in patients involving a Pfizer product and preventive interventional studies in healthy subjects involving a Pfizer product (e.g., vaccines studies) a manuscript reporting the results of the primary endpoint will be submitted to a peer-reviewed scientific journal within 18 months of the LSLV or the PCD, whichever is the earlier (this applies to studies with LSLV or PCD occurring on or after the effective date of this policy). For Pfizer Consumer Healthcare studies involving over the counter products or indications that are not approved by regulatory authorities (RAs) in any market, a manuscript reporting the results of the primary endpoint will be submitted to a peer-reviewed scientific journal within 18 months of the grant of marketing approval by the RA in a market.
An exception can be sought to not proceed with a manuscript for studies where there would be a limited value to the medical and scientific community in a manuscript (e.g., a study that was terminated after a small number of subjects were recruited for enrollment difficulties).
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., LSLV) at all sites, whichever occurs first.
Pfizer provides compensation to investigators for their work in conducting clinical studies but does not compensate for authorship of a primary publication about the results of the study.
All authors of a Pfizer-supported publication are provided access to relevant statistical tables and figures necessary to support the planned publication. When required, Pfizer will provide a protocol and/or the pre-specified plan for data analysis to a medical journal.
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.
2.5. Authorship of Medical 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 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 will be named as authors on medical publications. All those who deserve authorship credit based on these criteria will be named in the by-line and those who do not will 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 will be listed as an author.
The determination of who obtains authorship credit lies solely with the potential authors, in accordance with ICMJE guidelines.
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.
2.6. Investigator Access to Data and Review of Results
Pfizer will provide all investigators with a summary of study results, and as appropriate the treatment codes and serology results for his/her study subjects, after finalization of the Clinical Study Report when all subjects have completed the study. 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 RAs and Data Monitoring Committees. In certain cases, the database may be provided to the authors of publications, in consultation with legal.