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International Clinical Trials in Low Resource Countries S Rasmussen2, J McCarthy1, M Wilenzick1, U Kuruganthi1, J Dougl

2. Globalization of Clinical Trials: Current Environment. Increased complexity of studiesLarge multi-site trials, more participants, diverse populationsIncreased competition for investigators and subjectsLimited pool of treatment na?ve patients, especially in high resource countriesIncreased use

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International Clinical Trials in Low Resource Countries S Rasmussen2, J McCarthy1, M Wilenzick1, U Kuruganthi1, J Dougl

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    1. 1 International Clinical Trials in Low Resource Countries S Rasmussen2, J McCarthy1, M Wilenzick1, U Kuruganthi1, J Douglas1, A Wasunna3, R Hubbard2. Pfizer Global Research and Development1, External Medical Affairs2, and Worldwide Public Affairs and Policy3

    2. 2 Globalization of Clinical Trials: Current Environment Increased complexity of studies Large multi-site trials, more participants, diverse populations Increased competition for investigators and subjects Limited pool of treatment naďve patients, especially in high resource countries Increased use of outsourcing and greater use of CROs Greater utilization of commercial and central IRBs Most trials now conducted outside of academic research centers

    3. 3 Globalization of Clinical Trials: Ethics and IRB considerations If one examines ethical review systems and IRB authority, composition, and practices in the European Union alone—15 largely well-developed research environments and pharmaceutical markets—the findings are striking.… No two countries have the same review structure, the same requirements for ethical review jurisdiction, or the same procedures for submitting and evaluating applications to IRBs Transpose this situation to the 191 member states of the World Health Organization (WHO)—countries (and regions) with enormous political, social, and economic differences—and the requirements for achieving, understanding, and harmonizing ethical review practices in the globalized clinical trials marketplace are, at the very least, complex. F P Crawley, 1999

    4. 4 Global Distribution of Pfizer Clinical Trials

    5. 5 Location of Pfizer African Clinical Trial Placements by Number of Therapeutic Areas (1987-2007)

    6. 6 Societal Benefits of Doing More Trials in Low Resource Countries Better address neglected diseases Include a more diverse range of patients and participants in clinical trials Access untapped qualified investigators and large numbers of patients who would be eligible to participate Develop a broader base of expert clinical investigators Increase health / medical infrastructure in low resource countries Better alignment of clinical research with global business activities

    7. 7 Pfizer Commitments Pfizer maintains a long-standing commitment to ethical research. Clinical research ethics policies are posted on our corporate website. Pfizer regularly engages with international organizations regarding ethical issues in clinical research e.g. World Medical Association regarding revision of Declaration of Helsinki Pfizer follows ICH GCP, DOH, Belmont Report standards everywhere we do research All trials approved by applicable National Regulatory framework and appropriate local Ethical Committee review and oversight.

    8. 8 Existing Pfizer Policy on Global Clinical Trial Standards* 1. GCP & Ethics Compliance All trials to be conducted incompliance with relevant international standards, including ICH GCP, with IRB/IEC review, locally wherever available 2. Diversity Pfizer supports racial gender, and ethnic diversity, including representation of relevant subject groups in research protocols and among investigators 3. Informed Consent Voluntary, tailored to meet local laws, customs, and culture 4. Use of placebo and appropriate controls Control group must receive established effective treatment that is medically and ethically appropriate for the study. Placebo controls are allowable if there is no undue risk to health or well-being of participants. 5. Locale and benefit to Host country Research must have the potential to benefit each host country’s population 6. Post-trial Access Specifies in the IC the conditions for continued receipt of study drug 7. Support for study conduct Governs Pfizer commitment of necessary infrastructure and technological knowledge to adequately and appropriately conduct trials in low resource countries. * http://www.pfizer.com/research/science_policy/global_clinical_trial_standards.jsp

    9. 9 Pfizer’s Current Investigator’s Training Program “Modules” Introduction to ITP Drug Development Process Preparation and planning Recruitment and enrollment In-trial procedures Safety in Clinical Trials Monitoring, Audits, Inspections and publication Additional regulations Interactive Format Power point presentation slides Participants workbooks Group tasks Paper based Electronic (cd-rom) Quizzes Videos ICH-GCP guidelines Facilitator’s guide

    10. 10 Future Pfizer International Clinical Trials Program Maintain high ethical standards Focus of capacity building: lower resource countries Capacity building: training and accreditation: New investigators Ethics committees Collaborate locally Local research institutions Local health authorities Distinguished external bioethics panel advisory role

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