Standard of Care Indian context

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Standard of Care- Indian context

• Dr. Vasantha Muthuswamy, MBBS, DGO, MD, FABMS
• Sr. Deputy Director General
• Indian Council for Medical Research,
• New Delhi -110029
• muthuswamyv_at_icmr.org.in

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Standard of Care defined

• Required / agreed level of quality / achievement
  of provision of welfare and protection to avoid
  risk / damage / error
• (Ref Oxford Reference Dictionary 2001)
• Nature of the prevention and / or cure that will
  be provided to participants in research
• General care / treatment provided to all
  participants
• Special reference to care / treatment that should
  be provided to people in the control arm /
  placebo arm
• Care/treatment to those who are in the screening
  protocol and associated with study participants
• International debate Universal or Local

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ICMR Ethical Guidelines 2006

• International Collaboration
• Provision for the best possible nationally
  available care to participants

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Responsiveness

• Sponsor to negotiate with stakeholders and
  representatives of host country
• National government, health ministry
• Local health authorities
• Scientific and ethics groups
• NGOs and advocacy groups
• Negotiation with host community to include
• Setting health care infrastructure for use during
  and after the study
• Authorization for distribution
• Decisions about payments, royalties, subsidies,
  technology, intellectual property and
  distribution costs
• Discussion should involve international
  organizations, donor agencies, NGOs and the
  private sector

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• Stabilised in Tamil Nadu, Andhra Pradesh,
  Karnataka, Maharashtra
• Increasing in other states
• NACO 2007

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Preventive HIV/AIDS Vaccine Trial

• MoU - NACO, ICMR and global, not-for-profit
  International AIDS Vaccine Initiative (IAVI) in
  December 2000
• Extensive 2 year exercise initiated in 2002 to
  prepare the site, design the study and mobilise
  the volunteer groups before initiating the trial
• Initiation of 2 trials NARI,Pune and
  TRC,Chennai
• Phase I completed in both centres. Follow up is
  on.

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Community Engagement

• Developing Community Centered Research Agenda By
  incorporating the knowledge and expertise of
  community members
• Use Scientific Knowledge for Community Benefit
  Facilitate the balance between scientific agenda
  and the benefits to the community being
  researched
• Bridge the gap
• Research participants
• Communities in which they live
• Researchers

• Community Advisory Board CAB
• Community Involvement Plan CIP

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Additional Strategies of Community Involvement

• Principal Investigator directly talking with
  community
• Community based studies Adolescent, Standard of
  care, women and AIDS
• Exhibitions
• Marathons

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Vaccine trial Three tiered community
meeting Every volunteer underwent these meetings
1st level
2nd level
3rd level
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Care envisaged in protocol

• Care for HIV positives for life.
• Independent Arbitration Committee to decide
  compensation on related or unrelated
  conditions/events suffered by the participant.
• Insurance for trial related injury by IAVI
• Insurance for non-trial related injury by ICMR

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Initiatives in India

• 1 million people in 6 high prevalent states are
  receiving antiretroviral (ARV) drugs free of cost
  from 1st April 2004 targeted to 3 vulnerable
  groups
• mothers who participated in the Prevention of
  Parent to Child Transmission (PPTCT) program as
  seropositive antenatal cases
• seropositive children below the age of 15 years
• people with AIDS who seek treatment in selected
  government hospitals
• Govt of India in dialogue with pharma to optimize
  additional potential reduction in cost of ARV
  drugs

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Thank you