Building Capacity for Clinical Trials:

1
Building Capacity for Clinical Trials

• New Perspectives on Contracts, Conduct and
  Compliance
• Sheila B. Noone, Ph.D.
• Director, Office of Clinical Research
• University of Massachusetts Worcester (UMW)

2
Three objectives

• Summarize trends that will influence scale and
  complexity of clinical trials in Academic Health
  Centers (AHC)
• Emphasize critical components for building
  capacity in AHCs that ensure safe, ethical and
  reliable conduct of clinical research
• Highlight institutional re-engineering _at_ UMW
  necessary to achieve success re contracts,
  conduct compliance (work in progress!)

3
Central Message

• For improved health and QOL, we must create more
  efficient processes for translating scientific
  discovery innovation into clinical trials - and
  ultimately into clinical practice
• Requires collaboration from multiple stakeholders
  and a major shift in how we interact, negotiate
  and partner for successful implementation of
  clinical trials

4
Converging trends

• Incredible advancements in scientific knowledge
  - but concern that there are not tangible human
  benefits
• Acknowledgement of shift in disability due to
  chronic disease (chronic behaviors)
• An aging baby boom population

5
Converging trends

• Demand for new technologies and devices that
  decrease hospital stays
• Desire for improved surgical innovation and
  minimally-invasive procedures
• Demand for minimally invasive diagnostic tools
  (e.g., virtual colonoscopy)

6
Converging trends

• Emerging power of nanotechnology nanomedicine
• Convergence of medical devices and
  pharmaceuticals (drug-coated stents, needles and
  pumps to regulate insulin, transdermal
  diagnostics and drug delivery systems)

7
Converging trends

• New focus from NIH and AAMC on importance
  academic-industry partnerships
• NIH Roadmap new pathways to discovery research
  teams of the future re-engineering of clinical
  research enterprise
• http//nihroadmap.nih.gov
• AAMC recent task force formed to promote
  networks of collaboration, rather than singular
  competing efforts from institutions sponsor
  industry-AHC meetings and workshops

8
Building capacity

• Capacity-building requires examination of
  interventions that develop the abilities,
  behaviors, relationships and values that enable
  an organization to carry out complex tasks
• Central are notions of time, human resources,
  management of change and most important,
  sustainability

9
Building capacity for clinical trials

• Critical components include
• Understanding institutional priorities
• Initiating faculty discussions (dept. chairs)
• Clinical Research Advisory Committee
• Tend to relationship between stakeholders (e.g.,
  medical school and clinical system)
• Honestly examine current infrastructure metrics
  

10
Building capacity Shared responsibilities

• Examining study feasibility is most important
  step in study initiation
• history with sponsor/CRO
• protocol assessment
• Study valuable? Well-designed? Ethically
  acceptable? Inclusion/exclusion criteria
  reasonable?
• If investigator-initiated, subcontracting to
  other institutions? PI as sponsor

11
Building Capacity

• Study feasibility (continued)
• study population
• Access? Competing with other studies?
  Cross-department cooperation? Community
  recruitment? Advertising?
• Realistic enrollment estimates??????
• Realistic enrollment period? Recruiting non-
  English speaking subjects? Access to professional
  translation services?
• Are you recruiting vulnerable subject?

12
Building capacity

• Study feasibility (continued)
• Site resources
• Time the study requires? Adequate staff? Workload
  manageable for present staff?
• Coordination, regulatory burden
• Staff trained in GCPs? Study-specific procedures?
  Will sponsor train?
• If inpatient, will non-study staff need
  in-service?

13
Building Capacity

• Study feasibility (continued)
• Site resources equipment and facilities
• Adequate space?
• Equipment on-siteor provided by sponsor?
• Secure and adequate record storage?
• Remote data entrywill sponsor train? provide
  laptop?
• Almost all these issues influence study contract
  and study conduct

14
Clinical Research/Trial Agreements

• Re-engineering contract process _at_ UMW
• Increasing scale of clinical trials
• Increasingly complex contract terms more
  attention to GCP regulatory obligations
• New database to track contract process
• Requires collaboration of research administrator,
  investigator, IP legal office

15
CRA/CTA

• Often contentious contract terms
• Intellectual property
• Publication
• Indemnification
• Subject Injury
• New Resource from AAMC
• Clinical Trial Contracts A Discussion of
• Four Selected Provisions www.aamc.org

16
Study Conduct

• Eye-opening to audit sampling of clinical trials
  QI program since 2002
• Results of QI program drive the education and
  training efforts
• Although PI is ultimately responsible for all
  study conduct, institutional liability for poorly
  performed studies is high

17
Study Conduct

• Most deficits with study conduct and lack of
  adherence to GCP standards relate to confusion
  about roles and responsibilities (some relate to
  inattention to process)
• Good Clinical Practice (GCP) training is helpful
  in ensuring attention to detail
• UMW instituted two-day GCP training for CRCs on
  quarterly basis in 2003 - investigators more
  difficult

18
Building Capacity for Clinical Trials Lessons
Learned

• Competitive nature of industry trials makes
  efficiency in contract process essential but
  not at expense of careful review
• Approach each CRA/CTA as long-term relationship
• Well-trained workforce (appropriate to the
  complexity of trial) is the most important asset
  for GCP adherence

19
Lessons Learned

• A central support-oriented office can be pivotal
  in promoting safe, ethical reliable conduct of
  human subjects research
• Dedicated space to conduct studies may enhance
  both GCP standards and efficiency (Clinical
  Trials Unit opening mid-2004)
• Dont promise what you cant deliver applies to
  investigators and institutions

20
Most important lesson

• If an institutions goal is to promote and
  support clinical research growth, it must assume
  greater responsibility for ensuring a dynamic,
  responsive infrastructure.