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Policy on Global Clinical Trial Standards

1. Purpose

This policy sets forth the Pfizer standard with respect to global standards for the conduct of clinical trials/clinical studies, including clinical studies conducted in countries that do not have established infrastructure for human subject protection.

Pfizer strives to maintain high ethical principles, as well as high scientific and clinical standards, in all clinical studies regardless of where these studies are conducted. Pfizer studies are designed and conducted in accordance with local laws and generally accepted international regulatory standards. This policy is meant to ensure that Pfizer-sponsored studies respect the rights of all study participants.

2. Scope

This policy applies globally to all Pfizer-sponsored studies. This SOP applies to Pfizer colleagues within Worldwide Development (WWD), Safety and Risk Management (SRM), Worldwide Regulatory Affairs and Quality Assurance (WRAQA), Worldwide Medical, and the Pfizer Country Organizations (PCOs - Medical, Regulatory, Safety) in Worldwide Pharmaceutical Operations. It also applies to those parties with which Pfizer contracts (e.g., Contract Research Organizations [CROs] or consultants) who are involved in Pfizer-sponsored studies.

This policy applies globally to all clinical studies sponsored by Pfizer, including those conducted in countries that do not have established human subject protection infrastructure. This includes single-site studies, as well as multi-national, multi-site studies.

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3. Policy

It is Pfizer policy to sponsor, throughout the world, only high quality clinical research that follows accepted ethical, scientific, and clinical standards. Specifically, Pfizer takes measures to ensure that all its sponsored clinical studies are conducted in accordance with local laws and regulations, as well as relevant international standards such as the International Conference of Harmonization (ICH) Good Clinical Practices (GCP) Guidelines.

Pfizer recognizes that social and cultural considerations and needs in countries that lack adequate human subject protection infrastructure or laws may necessitate the implementation of additional measures to ensure appropriate protection and respect for the rights of study participants in the conduct of clinical studies in those countries.

3.1 Ethical Review

In order to ensure that appropriate ethical standards are observed, a qualified Institutional Review Board/Independent Ethics Committee(IRB/IEC) must review all Pfizer-sponsored clinical studies. If a qualified local IRB/IEC is not available, such review may be done through a centralized IRB/IEC provided that the IRB/IEC has expertise in or experience with the ethical and medical practices in the host country. Additionally, there must be review by a medical professional in the local country.

3.2 Diversity

Pfizer and investigators conducting research on behalf of Pfizer recruit research subjects according to inclusion and exclusion criteria defined in the clinical protocol, in accordance with the scientific goals of the study. Pfizer supports racial, gender, and ethnic diversity in clinical research, including representation of relevant subject groups in our research protocols and among our clinical investigators.

3.3 Informed Consent

All study participants must provide voluntary informed consent after receiving appropriate information that shall include information about the risk of participating, research design, and possible post-study benefits. The procedures for obtaining voluntary informed consent may be tailored to meet local laws, customs, and culture. Pfizer works with investigators and local health authorities or community representatives to ensure the appropriateness of the informed consent process and the information provided during that process.

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3.4 Standard of Care

Pfizer provides the control group with an established effective treatment that is medically and ethically appropriate for the study. Placebo-controlled studies may be utilized where doing so does not present undue risk to the health or well-being of the study participants. In all cases, the IRB/IEC must review the appropriateness of the proposed treatment for the control group.

3.5 Appropriateness

Pfizer-sponsored clinical research must be relevant to the host country's health needs. In order to be conducted in a particular country, research must have the potential to benefit that country's population.

3.6 Follow-up

Each clinical protocol must have a decision point to determine the appropriateness, relevance, and feasibility of continuing to provide the investigational product and/or control drug to research participants at the conclusion of the clinical study. The protocol must also address how individualized determinations of need and appropriateness is made. That assessment normally includes consideration of the local availability of the treatment and alternative treatments, the specific development stage of the investigational product, individual subjects' study results, the seriousness of the disease being treated, the global results of the research program, and the overall safety and risk/benefit ratio of the investigational product. In the informed consent process, potential research participants are informed if Pfizer anticipates that subjects may continue to receive control or investigational product after the study is completed and if so under what conditions. As the study progresses, Pfizer updates subjects of any material changes in Pfizer's plan regarding post-study access to control or investigational product.

3.7 Technology Transfer

If there is no infrastructure in place in the host country for adequate ethical review and/or conduct of the clinical study, Pfizer works with local investigators, medical personnel and facilities, health authorities, local leaders, and others to help develop or provide the necessary infrastructure and technological knowledge to adequately and appropriately conduct the clinical study.

4. Responsibilities

Study teams are responsible for designing and implementing all clinical research in accordance with this policy.

Exceptions to this policy may not be made without approval of senior management, including the Chief Medical Officer, and Legal.

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