Global Standards for Interventional Clinical Studies

1. Purpose

This policy sets forth the Pfizer global standards for the conduct of Pfizer-sponsored interventional clinical trial/studies. These studies must address clinically relevant questions and be designed and conducted in accordance with the highest scientific and ethical standards as well as regulatory requirements. This policy is meant to ensure that Pfizer-sponsored interventional clinical studies respect the rights and welfare of study participants.

2. Scope

This policy applies globally (i.e., anywhere in the world) to all Pfizer-sponsored interventional clinical studies.

This policy applies to all Pfizer colleagues and to those parties with whom Pfizer contracts (e.g., Contract Research Organizations [CROs], vendors or consultants) who are involved in Pfizer-sponsored interventional clinical studies.

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3. Policy

All Pfizer-sponsored interventional clinical studies must be conducted in accordance with local laws and regulations, as well as relevant international standards including the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), International Conference on Harmonisation Good Clinical Practices (ICH-GCP) Guidelines, the ethical principles set forth in the Declaration of Helsinki (WMA 2008) and the US Belmont Report (1974).

All Pfizer-sponsored interventional clinical studies must be responsive to the healthcare environment of the country or countries where the research is conducted. Social and cultural considerations and needs in countries that lack established infrastructure for human subject protection, may require additional measures to ensure appropriate protection and respect for the rights, privacy and welfare of study participants. Informed consent, risk/benefit assessment, and the selection of subjects for research will conform to CIOMS and ICH guidelines, and apply the principles of the Declaration of Helsinki and Belmont Report.

Pfizer demonstrates compliance with all applicable laws and regulations in those countries or regions where we conduct business and provides appropriate records and other information to authorized government representatives in the course of inspections.

3.1 Risk/Benefit Maximization

Pfizer-sponsored interventional clinical studies must have favorable benefit-risk ratio (e.g., the known or foreseeable risks to the subjects must be justified by the expected benefits, direct or indirect), and must be designed and conducted to maximize the benefit and minimize risks.

3.2 Ethical Review

A qualified Institutional Review Board or Independent Ethics Committee (IRB/IEC) must review and approve Pfizer-sponsored interventional clinical studies before the study is conducted. That review may be done by a central IRB/IEC, as well as local IRB/IECs that review proposed research for a specific research organization or clinical trial sites.

IRB/IECs enlisted to review Pfizer protocols must be independent from Pfizer and have members with appropriate medical and scientific qualifications and be knowledgeable about the community where the study will be conducted.

Subjects may not be enrolled into Pfizer-sponsored interventional clinical studies until written authorization is received from the IRB/IEC as well as the appropriate regulatory or official governmental body from the country in which the study will be conducted, as described by local regulations.

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3.3 Protocol Inclusion and Exclusion

Protocols must define the eligibility criteria for the study, based on medically sound criteria and ensure that the study population is scientifically appropriate. All subjects must satisfy all of the eligibility criteria and all study specific procedures and assessments must be performed as described in the protocol and in accordance with the scientific goals of the study.

Diversity in clinical research (e.g., including diverse racial, gender, ethnic populations) should be sought as much as possible, as well as diversity among the clinical investigators and staff retained to conduct the study.

3.4 Informed Consent

Subjects may only be enrolled or receive study procedures after providing their voluntary informed consent. Informed consent must be documented in writing as part of the informed consent process in accordance with Council for International Organizations of Medical Sciences (CIOMS) and Pfizer standards, including disclosure of the material risks associated with participation in the trial, and be given an opportunity to discuss those risk and the availability of other treatments with the investigator and/or qualified study staff.

The permission of a legally authorized representative, in accordance with applicable local law, is required for vulnerable populations who are not capable of giving informed consent (e.g., pediatric subjects, decisionally-impaired). Such subjects are afforded the opportunity to provide or withhold their assent, whenever possible.

The procedures for obtaining voluntary informed consent shall be tailored to meet local laws, customs, and culture but may not diminish or compromise the rights of the proposed study participant. Pfizer works with investigators and local health authorities or community representatives to ensure the appropriateness of the informed consent process, in accordance with Pfizer standards.

3.5 Standard of Care and Use of Placebo Controls

Where Pfizer-sponsored interventional clinical studies involve control groups, the control must be either an established effective treatment that is medically and ethically appropriate for the study or, where appropriate, a placebo. Placebo-controls may only be used in Pfizer sponsored interventional clinical studies where:

• there is no established effective treatment,
• withholding an established effective treatment would expose subjects to, at most, temporary discomfort or delay in relief of symptoms; or
• use of an established effective treatment as comparator would not yield scientifically reliable results and use of a placebo control would not add any risk of serious or irreversible harm to the subjects.

In all cases, the IRB/IEC must review the appropriateness of the proposed treatment for the control group.

3.6 Trial Placement

Pfizer-sponsored clinical research in patients must be relevant to the host country's health needs. In order to be conducted in a particular country, the clinical research must have the potential and be intended to benefit that country's population. Trials may only be placed in countries where Pfizer intends to commercialize the investigational medicine, if it is proven to be safe and effective.

3.7 Study Team Responsibilities

Pfizer-sponsored clinical research must be designed, conducted, and monitored to ensure the protection of the rights and safety of study subjects, compliance with laws, regulations, and ethical standards, and the integrity of research data.

Pfizer may transfer specific study functions to a CRO but the responsibility for the quality and integrity of study conduct and data resides with Pfizer.

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3.8 Monitoring

Pfizer-sponsored interventional clinical studies must be monitored by trained personnel to assess the protection of subject's rights and welfare and to ensure that the study is being conducted in accordance with the protocol and with Pfizer standards. All studies with more than one study site are required to create and maintain a study monitoring plan.

All suspected deviations must be promptly investigated and appropriate action taken to ensure patient safety, obtain compliance, document deviation and corrective action and, where possible, implement preventative action.

3.9 Data Monitoring Committees

Data Monitoring Committees (DMCs) are used to monitor safety in randomized studies with mortality or major morbidity as primary or secondary endpoints, studies where study participants may be at elevated risk of such outcomes, and other studies where an independent review of study data is warranted. Establishment and conduct of the DMC follow international and local requirements, in accordance with Pfizer standards.

3.10 Control of Investigational Product

All products under investigation are tracked and controlled from the time they leave Pfizer through to their use, appropriate disposal or return to Pfizer. Pfizer ensures that records documenting the control of investigational product are established for all Pfizer-sponsored interventional clinical studies, in accordance with Pfizer standards.

3.11 Essential Documents

All essential documents for Pfizer-sponsored interventional clinical studies must be maintained and archived in accordance with ICH GCP standards, applicable regulatory requirements, and Pfizer standards.

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3.12 Post Study Care

For all Pfizer-sponsored interventional clinical studies a determination is made prior to enrollment of the appropriateness, relevance, and feasibility of continuing to provide the investigational product and/or alternative therapies to research participants at the conclusion of the study, or other necessary follow-up care. This determination may include consideration of local availability of the treatment and alternative treatments, the development stage of the investigational product, the seriousness of the disease being treated, the global results of the research program, the overall safety and risk/benefit ratio of the investigational product as well as individual subject study results.

3.13 Subject Access to Health Information From Studies

Subjects may request access or changes to health information arising from their participation in a Pfizer-sponsored interventional clinical study. Such requests are made to the physician or investigator treating them in the study. Pfizer works with investigators to facilitate access to laboratory or other data about individual subjects, in response to such requests and in accordance with local regulations and standards.

4. Responsibilities

The clinician responsible for the study, along with the study team, design Pfizer-sponsored interventional clinical studies and ensure they are conducted in accordance with this policy.

In addition to the formal waiver processes, according to Pfizer standards, exceptions to this policy may not be made without approval of senior management, including the Chief Medical Officer (CMO), and R&D Legal.

5. Appendices

CT19-01 Country-Specific Legal and Regulatory Requirements

CT19-02 Version Control of Clinical Study Documents

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