Public Disclosure of Pfizer Clinical Study Data and Authorship
Effective December 1, 2014
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. Pfizer is committed to meeting the five Principles for Responsible Clinical Trial Data Sharing identified by the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America. The purpose of this clinical and medical controlled document policy is to describe the requirements for:
- Registration of Pfizer-sponsored studies.
- Posting of study results by Pfizer, including enhanced public access to clinical study information
- 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
- Enhanced data sharing with researchers
- Sharing of results with patients who participate in clinical trials, with a focus on comprehension and the enhancement of medical literacy
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 Businesses as well as the platform and functional lines responsible for clinical and medical communications, medical affairs, and medical activities including research, development, regulatory, and pharmacovigilance.
- Pfizer-sponsored studies in human subjects, including interventional and non-interventional studies.
- A partnership between Pfizer and another company for the clinical development and/or marketing of a product. Pfizer and the other company will agree as to which party has responsibility for all processes related to registration of studies and posting of results. However, Pfizer nonetheless retains responsibility for registration and posting of results for all studies sponsored by Pfizer (e.g., when Pfizer holds the United States 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:
- Pfizer non-sponsored studies (i.e. Investigator Initiated Research) and collaborations including but not limited to Clinical and Research Collaborations that are not sponsored by 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 funding, 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 for consideration.
2.1. Registration of Clinical Studies
Pfizer registers all Pfizer-sponsored interventional studies in human subjects on www.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 – Including Enhanced Public Access to Clinical Study Information
- Regardless of the geographical location in which the study was conducted, Pfizer posts Basic Results on www.clinicaltrials.gov (hereafter referred to as ClinicalTrials.gov) for Pfizer-sponsored studies conducted in patients that evaluate the safety and/or efficacy of a Pfizer product.
- Pfizer posts results of Pfizer-sponsored studies in scope with the European Union requirements posted on EudraCT in accordance with the timing and modality set forth by the European Medicines Agency.
- Pfizer posts Clinical Study Report Synopses where any data that could be used to identify individual patients has been removed (Public Disclosure Synopses) for Pfizer-sponsored studies, that were initiated after Sept 27, 2007, or initiated on or before that date and were still ongoing as of Dec 26, 2007. The synopsis is posted to Pfizer.com at the same time the Basic Results document is posted to ClinicalTrials.gov.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.
- 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.
Note: Sections 2.1 and 2.2 do not apply to studies registered on databases other than the ClinicalTrials.gov. However, study teams are strongly encouraged to ensure that study registration and results data on other databases are consistent with the information posted on ClinicalTrials.gov.
2.3. Public Disclosure of Phase 3, Phase 3B and Certain Phase 4 Clinical Study Data
- 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 product’s efficacy and/or safety). This is limited to hypothesis-testing studies (i.e., those that 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 Pfizer Businesses. If a decision is made to include secondary endpoints in the disclosure, 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 study results are disclosed regardless of 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.
- The need and time to inform regulators must be taken into consideration regarding the timing of the press release. The study results are disseminated as soon as practicable after the availability of the results of the primary endpoints.
- If the study results (regardless of phase) are considered material, a press release may have to be issued as soon as practical after the availability of the results of the primary endpoints.
- Study results cannot be shared with third parties (other than regulators and development partners, as necessary) before a press release is issued, 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.
Note: Section 2.3 does not apply to:
- Clinical studies conducted by the Pfizer Consumer Healthcare Business Unit
- Non interventional 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 co-development partners and to make reasonable efforts to obtain endorsement.
2.4. Publication of Pfizer-Sponsored Studies
- Pfizer is committed to developing publications that report the results of Pfizer-sponsored clinical studies in a transparent, accurate, fair, and balanced manner. For all Pfizer-sponsored interventional clinical studies in patients involving a Pfizer product (investigational compounds and marketed products) and for preventive interventional studies in healthy subjects involving a Pfizer product (e.g., prophylactic vaccine studies), a manuscript reporting the results of the primary endpoint will be submitted to a peer-reviewed scientific journal within 18 months of the last subject last visit or the primary completion date, whichever is earlier (this applies to studies with last subject last visit or the primary completion date 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 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 receiving the marketing approval by the Regulatory Authorities in a market.
- An exception may be sought to not proceed with a manuscript for studies where there would be 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. 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 last visit) 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, figures, and reports (e.g. Clinical Study Report 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 patient welfare in mind.
2.5. Authorship of Medical Publications
- Pfizer implements the authorship criteria established by the International Committee of Medical Journal Editors and the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.
- Pursuant to the International Committee of Medical Journal Editors 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 International Committee of Medical Journal Editors 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, he or she will be listed as an author.
- The determination of who to consider for authorship credit lies solely with the potential authors, in accordance with International Committee of Medical Journal Editors guidelines.
- Where Pfizer hires technical support to help analyze and interpret data or editorial support to 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.
- The Sunshine Act, a part of the Affordable Care Act, requires Pfizer to report to the U.S. government certain payments and transfers of value to U.S.-licensed physicians. Editorial or technical support may be a reportable transfer of value. If a Pfizer colleague provides, assists with, or is involved with providing or arranging for editorial or technical support to an author who is a U.S.-licensed physician, that colleague must consult the latest version of the Healthcare Professional Disclosure SOP to review the process for collecting and reporting information on editorial or technical support.
2.6. Investigator Access to Data and Review of Results
- For Pfizer sponsored interventional studies involving the use of a Pfizer product, 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. However, when an investigator is an author of a Pfizer-supported publication that reports the results of a Pfizer-sponsored clinical study, the investigator must be provided with all relevant statistical tables, figures, and reports (e.g. Clinical Study Report) necessary to support the planned publication. 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. In certain cases, the database may be provided to the authors of publications, in consultation with legal.
2.7. Enhanced Data Sharing with Researchers
- Pfizer provides secure access to patient-level data or full Clinical Study Reports for the purposes of “bona-fide scientific research” that will contribute to the scientific understanding of the disease, target, or compound class. Data will be available for studies for which Basic Results have been posted to ClinicalTrials.gov, dating back to 2007.
- Requests will be considered from qualified researchers with the appropriate competencies to perform the proposed analyses. Research teams must include a biostatistician. Data will not be provided via this process to applicants with significant conflicts of interest, including individuals requesting access for commercial/competitive or legal purposes.
- Patient-level data for approved requests will be anonymized in accordance with applicable privacy laws and regulations.
- Clinical Study Reports will have personally identifiable information redacted.
2.8. Sharing of Results with Patients Who Participate in Clinical Trials
For Phase 2B and Phase 3 studies where the first patient first visit occurred on or after January 1, 2014, Pfizer will provide summaries of the trial findings to participants in easy-to-read, non-technical language, in countries where regulations allow it. These patient summaries review why the study was done, how it was done, and the results.