International Trials in Emerging Markets by liuqingyan


									International Clinical Trials in Low Resource
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

      Globalization of Clinical Trials:
          Current Environment
• Increased complexity of studies
• Large multi-site trials, more participants, diverse
• 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
   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

Global Distribution of Pfizer Clinical Trials

                                                N America /W Europe
                                                E Europe
                                                Asia (excl Japan)
                                                Latin America
                                                Africa / M East

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

              Pfizer Commitments
• Pfizer maintains a long-standing commitment to ethical
   – Clinical research ethics policies are posted on our corporate
• 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.

                      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
            Pfizer’s Current Investigator’s
                  Training Program
• ―Modules‖                               • Interactive Format
   –   Introduction to ITP                   – Power point presentation
   –   Drug Development Process                slides
   –   Preparation and planning              – Participants workbooks
   –   Recruitment and                       – Group tasks
       enrollment                                 • Paper based
   –   In-trial procedures                        • Electronic (cd-rom)
   –   Safety in Clinical Trials             –   Quizzes
   –   Monitoring, Audits,                   –   Videos
       Inspections and publication           –   ICH-GCP guidelines
   –   Additional regulations                –   Facilitator’s guide
 Conducted globally in over 25 different countries; translated in 7 languages

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

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