Public Disclosure of Pfizer Clinical Study Data and Authorship
Effective February 15, 2018
1. PURPOSE & SCOPE
The purpose of this clinical and medical controlled document policy is to describe the requirements for making clinical studies and clinical study results available to the medical community, to study participants, and to the public in compliance with applicable regulations as well as the authorship criteria established by the International Committee of Medical Journal Editors.
Additionally, 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.
This policy contains the requirements for:
- Registration of Pfizer-sponsored studies and study status
- Posting of study results by Pfizer
- Publication of Pfizer-sponsored studies
- Authorship of Pfizer-sponsored studies
- Press releases of Phase 3 (including Phase 3B) and certain Phase 4 clinical study data
- Investigator access to data from studies in which they participated
- Sharing results with Study Participants’ from studies in which they participated
- Enhanced data sharing with researchers
2. POLICY STATEMENTS
Deliverables (i.e., study registration, Basic Results posting, public disclosure synopsis, publications, data sharing with researchers/investigators, results sharing with study participants and, press releases) accurately reflect in appropriate terms the results from the scientific and medical conclusions drawn from the study; and meets the regulatory authority specifications.
Study results are reported by Pfizer in an objective, accurate, balanced, and complete manner regardless of the outcome of the study or the country in which the study was conducted.
Pfizer Commercial colleagues, with the exception of Health &Value colleagues involved in designing and conducting research related to health economics and real world data, must not be involved in the funding, preparation, planning, or content development for publications. Involvement is limited to an optional annual meeting with the publication team where marketing may provide non-binding suggestions to the publication team for consideration.
3. PUBLIC DISCLOSURE
Pfizer is responsible to ensure that study registration and results data posted publicly on other databases are consistent with the information posted on ClinicalTrials.gov.
Non-interventional post-authorization safety studies are posted in accordance with Guideline on Good Pharmacovigilance Practices EMA Guidance - Guideline on Good Pharmacovigilance Practices - module VIII 09-Oct-2017 I on the European Union Post Authorization Safety Study register; European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
3.1. Registration of Clinical Studies
- All Pfizer-sponsored interventional clinical studies in human subjects on ClinicalTrials.gov that involve a Pfizer product and/or non-Pfizer product) that evaluate the safety and/or efficacy of a product.
- All Pfizer sponsored non-interventional studies on ClinicalTrials.gov that evaluate the safety and/or efficacy of a Pfizer product.
- Expanded Access (compassionate access) protocols that involve a non-approved product.
3.2. 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 studies conducted in patients that evaluate the safety and/or efficacy.
- Pfizer posts results of Pfizer-sponsored studies according to the European Union requirements posted on EudraCT in alignment with the timing and modality set forth by the European Medicines Agency.
- Pfizer posts Public Disclosure Synopses for Pfizer-sponsored studies that were initiated after 27-Sep-2007, or initiated on or before that date and were still ongoing as of 26-Dec-2007. The synopsis is posted to Pfizer.com at the same time the Basic Results document is posted to ClinicalTrials.gov
4.1 Publication for Pfizer-Sponsored Studies
- Pfizer develops 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 products 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(s) is 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 primary completion date occurring on or after 02-Jan-2013.
- 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(s) is submitted to a peer-reviewed scientific journal within 18 months of receiving the marketing approval by the regulatory authorities in a market.
- All authors of a Pfizer-supported publication that reports the results of a Pfizer-sponsored clinical study, must be provided with all relevant statistical tables, figures, and reports, in their original format, (e.g., Clinical Study Report) necessary to support the planned publication.
- Pfizer does not compensate investigators for authorship of a publication regarding the primary results of the study.
- Pfizer reserves the right to review any manuscripts, presentations, abstracts, or other public disclosures related to Pfizer-sponsored studies or that utilize Pfizer data before they are submitted for publication or are otherwise publicly disclosed.
- Pfizer responds in a timely manner to 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.
4.2. Authorship of Medical Publications
Pfizer adheres to the authorship criteria established by the International Committee of Medical Journal Editors and the Pharmaceutical Research and Manufacturers of America.
The Sunshine Act, a part of the Affordable Care Act, requires Pfizer to report to the United States government certain payments and transfers of value to United States 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 United States.-licensed physician, that colleague must consult the latest version of the healthcare professional disclosure standard operating procedure to review the process for collecting and reporting information on editorial or technical support.
5. PRESS RELEASES
5.1. Press Releases of Phase 3, Phase 3B and Certain Phase 4 Clinical Study Data
This section does not apply to:
- Clinical studies conducted by the Pfizer Consumer Healthcare Business Unit
- Non-interventional studies
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 outcome of key 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 to deliver an accurate, complete, and informed communication.
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). 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 are considered material, a press release will be issued as soon as practical after the availability of the results of the primary endpoints.
- Details of the results may be provided at the discretion of the sponsoring Pfizer organization. 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.
- 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.
- Study results cannot be shared with third parties before a press release is issued, unless they are bound by confidentiality obligations.
6. DATA SHARING
6.1 Investigator Access to Data and Review of Results
For Pfizer-sponsored interventional studies involving the use of a Pfizer product only:
- Pfizer provides 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 Reports when all subjects have completed the study.
- 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. Pfizer will consider reasonable requests from investigators for additional analyses of multi-center study results.
- In certain cases study databases are made available to regulatory authorities and Data Monitoring Committees, and in certain cases, the database may be provided to the authors of publications, in consultation with legal.
6.2. Enhanced Data Sharing with Researchers
- Pfizer provides researchers secure access to patient-level data or full Clinical Study Reports for the purposes of “bona-fide scientific research” that contribute to the scientific understanding of the disease, target, or compound class. Pfizer will make available data from these trials 24 months after study completion.
- Data requests are considered from qualified researchers with the appropriate competencies to perform the proposed analyses. Research teams must include a biostatistician. Data will not be provided to applicants with significant conflicts of interest, including individuals requesting access for commercial/competitive or legal purposes.
- Patient-level data will be anonymized in accordance with applicable privacy laws and regulations.
- Clinical Study Reports will have personally identifiable information redacted.
6.3. Sharing Results with Clinical Trial Participants
For Phase 2 and Phase 3 studies that began after 01-Jan-2014, Pfizer provides a summary of the study results in English to participants in easy-to-read, non-technical language. The summary explains the purpose of the study, how the study was conducted, and the primary endpoint and safety results from the study regardless of the outcome of the clinical trial.