Community outreach in MRC national and international trials

1
Community outreach in MRC national and
international trials

• Simon Collins
• HIV i-Base, London
• UK-CAB and ECAB

2

• Community outreach
• Involvement at all levels of our care
• Individual treatment decisions
• Community education
• Trial design
• International networks
• Resourcing and development
• Questions throughout

3

• Community Advisory Boards (CABs)
• Specialise in scientific training
• Trial review and design
• Representation on Steering and Executive Cttees,
  DSMB, Guidelines cttes
• High involvement of HIV advocates
• Network for 2-way communication to advise the
  trial and to report through community networks

4

• CAB networks
• National CABs
• UK-CAB France (TRT-5) Italy Spain (FEAT)
  Germany Portugal
• European CAB (ECAB) - Pan European advocacy
  group - working group of European AIDS Treatment
  Group
• World CAB - global access and pharmaceutical
  pricing (generic and brand), and part of
  International Treatment Preparedness network
  (gt600 members, gt120 countries

5

• UK-CAB.1
• 4 yrs old, 130 members from UK
• Broad representation of affected communities
  approx 50 African, 50 men/women 70 HIV and
  includes haemophilia and IDU networks
• Includes all main ASOs - ie producers of
  community publications plus individuals
• 4 meetings/year (30 people) - at MRC training
  and strengthening support network

6

• UK-CAB.2
• Linked by email list treatment discussion,
  including related policy issues administration
  for meetings and reports
• Chooses community reps for trial cttees
  (national, Optima, Esprit, Silcaat, SMART,
  INSIGHT, PENTA) and guidelines (BHIVA)
• Forum for communication out from trials and
  research networks
• Accountable to the wider community

7

• European CAB (ECAB)
• Pan-European CAB Approx 35 members from 20
  countries
• 5-6 meetings annually, each 3 days
• Meets all major companies running international
  trials, and works closely with networks of
  independent investigators
• Includes Protocol Review Group
• All national CABs are represented

8

• European CAB (ECAB).2
• Choosing community representatives for
  international steering cttes, treatment
  guidelines panels (resistance, adherence,
  treatment, coinfection) and often for involvement
  in scientific meetings
• Advocates are active in their own countries and
  well connected to those community networks

9

• MRC trials
• As with all trials, community representation is
  expected on scientific and steering committees,
  and sometimes on DSMBs
• Help focus trial design that will continue to be
  relevant from community perspective
• Helps faster enrollment, and greater publicity
  in the community
• Can raise and communicate problems to wider
  community

10

• Example Esprit/Silcaat
• Community represented in trial design and at
  investigator meetings, including presenting
  issues form community perspective
• Raise safety concerns over management (ie issue
  of dose reduction)
• Raise trial profile (UK enrolled highest number
  of patients)
• Advocate for Silcaat to continue after Chiron
  withdrew funding

11

• Example SMART
• Community involved in initial discussions (gt5
  years ago)
• Community reps on each of 4 regions organising
  and investigator committees
• High community profile of trial contributed to
  rapid enrollment
• Working with community representatives, helped
  communicate difficult and sensitive results
  following DSMB-recommended discontinuation in
  January 2006

12

• Conclusions
• Community partnership is essential in trial
  networks
• Requires resourcing when planned most advocates
  volunteer for CAB work
• Significant community training required for
  representatives to be actively involved
• Resources are especially important for
  international trials (where one advocate may
  represent several countries)