Conducting MultiSite Collaborative Studies

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Conducting Multi-Site Collaborative Studies

• Lessons Learned and Their Implications for
  Assessing the Impact of Childhood Interventions
  on Subsequent Drug Abuse

Audrey Smith Rogers, NICHD
May, 2000
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Some Funding Mechanisms

• Unsolicited RO1s
• Request for Applications (RFA) -solicited
  RO1s -solicited UO1s
• Program Announcements (PA)

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Situations in which multi-site research may be
indicated

• Need a large number of study subjects - arising
  from study question or - required to address
  loss-to-followup
• Cases rare
• Geographic distribution important to the question
• Need adequate numbers of important subgroups
• Benefit to having broader scientific expertise

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The UO1

• A cooperative agreement supporting a discrete,
  specified, and circumscribed research project

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Two Approaches to UO1s

• Same Theme
• Common Objective
• Independent Studies
• Cross-fertilization

• Same Theme
• Common Objective
• Common Base Protocol
• Collaborative Work

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Collaborative Work / Base Protocol

• Scenario One Individual investigators
  who have access to subjects of
  interest Challenges May but does
  not always include the best theoreticians or
  scientists

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Collaborative Work / Base Protocol

• Scenario Two -Basic Science Investigators
  with individual hypothetical proposals -Inve
  stigators who have access to subjects Challenges
  -Establish harmony to produce base
  study -And do so in timely manner -Establish
  harmony with clinical investigators

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Collaborative Work / Base Protocol

• Scenario Three -Principal Investigator and
  Leadership Group with necessary credentials and
  plan to achieve project objectives, competing
  with others -Investigators who have access to
  subjects Challenges -Establish harmony
  with clinical investigators

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Harmony with Clinical InvestigatorsSome
possible problems

• Investigators with clinical access to at-risk
  populations are stressed with the provision of
  under-funded health services
• Concerns about the balance of wearing two hats
  care-giver and study director
• Little expertise in study design and limited
  experience in implementing clinical research

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Harmony with Clinical Investigators-Some
possible solutions

• Investigators need to be involved in the schedule
  of assessments in order to produce a protocol
  that will not inordinately burden the subjects or
  staff
• Investigators need the opportunity to discuss
  health care issues within the research setting
  and to be heard and supported in balancing
  demands
• Research mentoring- formally and informally

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Multi-site Research Challenges

• Agreement on specifics of protocol e.g. Nature
  and frequency of measurements
• Provision of appropriate executive function viz.
  response to crises and poor performance
• Training and standardization
• Site monitoring
• Real-time and effective communication
• Pro-active planning

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Multi-site Research Challenges

• Program issues -Presence and involvement
  -Targeted, tailored funding -Effective
  management of resources -Assessment and
  solicitation of productive consortium
  arrangements -Creative thinking, stressing
  possibilities

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Multi-site Research Challenges

• Subject issues -Safety -Recruitment
  -Retention -Tracking -Service
  s -Compensation -Information and
  feedback -Community Advisory Board
  Representation

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Multi-site Research Challenges

• Institutional issues -Institutional Review
  Board -Provision of adequate ancillary
  services -Supply of necessary clinical support
  staff -Establish comfortable, friendly
  environment

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Multi-site Research Challenges

• How to accommodate emerging scientific
  issues -Expand internally Supplemental funding
  for specific proposals -Expand
  externally Collaborate with investigators in
  applying for RO1s or responding to
  PAs -New mechanism the discretionary
  research fund in cooperative agreements