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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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1. 1 International Clinical Trials in Low Resource CountriesS 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