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

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
Globalization of Clinical TrialsCurrent
Environment

• Increased complexity of studies
• Large multi-site trials, more participants,
  diverse populations
• Increased competition for investigators and
  subjects
• Limited pool of treatment naïve 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
Globalization of Clinical Trials Ethics and IRB
considerations

• If one examines ethical review systems and
  IRB authority, composition, and practices in the
  European Union alone15 largely well-developed
  research environments and pharmaceutical
  marketsthe 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 differencesand
  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
Global Distribution of Pfizer Clinical Trials

• Historically, the great majority of Pfizer
  clinical research trials have been conducted in
  the developed world i.e., N America, W Europe
  (and Japan)
• There is a desire and need to increase diversity
  of clinical trial placements to include Asia,
  Africa and the Middle East

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

• Therapeutic Areas
• Infectious Diseases
• Inflammation
• Metabolic Disease
• Cardiovascular
• Genitourinary
• Pain
• Respiratory
• Oncology
• Opthalmology
• Neuroscience

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
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
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 countrys 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

9
Pfizers Current Investigators 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
• Facilitators guide

Conducted globally in over 25 different
countries translated in 7 languages
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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