Yale Center for Clinical Investigation: Academic Home to the CTSA

Secretary’s Advisory Committee on Human Research Protections (SACHRP) Presentation

Tesheia H. Johnson, MBAOctober 30, 2007 Yale University

School of Medicine

Major Programmatic Goals of CTSA Program

CTSA Regulatory Knowledge Working Group Priority Areas:

1. Define and develop the mission, scope and model for the Research Subject Advocacy (RSA) role in the CTSA.

2. Define and develop the mission, scope and model for the Clinical Research Coordinator (CRC) role in the CTSA.

3. Facilitate IND/IDE support for the CTSAs

4. Facilitate understanding of the changing CMS regulations and the impact on regulatory activities

• Regulatory Support for research teams to protect human subjects and facilitate regulatory compliance.

• To create a true “One Stop Shopping” for all resources needed for the design, implementation & oversight of clinical and translational research studies.

The Local Setting

Challenges/ Roadblocks

• Developing a structure that will maximize subject safety and allow for data collection for tracking purposes, without developing institutional processes which will be burdensome to investigators

The CTSA Opportunity

• To consolidate the review process

• Work collaboratively with University Compliance and Contracting Offices

• Work collaboratively with other categorical centers for the benefit of clinical researchers

The Local Setting, continued

Challenges/ Roadblocks

• The IRB has become a institutional gate keeper of many non- human subject safety issues. The challenge is to now define institutional roles: • What should exist as a

function of the center?• What should be an IRB

function?

“IRB Mission creep”

The CTSA Opportunity

• Encourage compliance through facilitating the research process

• Take on non- Human Subject Safety functions like IND

• Work collaboratively on a centralized electronic system for all review functions

US Reduction in the Market Share: Sources of 1572 filings

0

20000

40000

2002 2003 2004 2005 2006

Total Filings

US

Abroad

Source: Thomson CenterWatch Analysis 2006; FDA, 2006

Causes of Study Initiation DelaysUnited States

34%

52%

38%

45%

29%

37%

24%

35%

18%

28%

0%

25%

50%

75%

Contract/budgetnegotiation &

approval

Patientrecruitment &

enrollment

Protocolamendment &

refinement

IRB review &approval

Review &approval of

consent form

2003

2005

Source: Thomson CenterWatch 2003 (n=396); 2005 (n=612) Survey of Investigative Sites in the U.S.

The National Setting

Challenges/ Roadblocksto the Human Subjects System

• Multi-center studies• Each institution has a

separate review • Within an institution a study

may have 4 to 5 internal reviews prior to approval

• Institutional IRBs require faculty service time• “What will this do for my

career?”

• IRB is responsible for safety – Who takes on the other issues

The CTSA Opportunity

• Testing ground for new models of review

• Learn from others: Industry experience with commercial IRBs, NCI experience with central IRB, etc

• Work collaboratively with other categorical centers for the benefit of clinical researchers

• Develop support models for non-safety functions

The National Setting , continued

Challenges/ Roadblocksto the Human Subjects

System

• In addition to multiple reviews, researcher are subject to multiple audits often with conflicting requirements

• Short life of the research career

• Negative public perceptions of clinical research

The CTSA Opportunity

• CTSA and NIH working collaboratively with clinical research stakeholders (FDA, OHRP, research community, etc)

• Cross NIH expertise

• Developing new structure that will facilitate research (training, regulatory, study support)

• Best practices for study implementation and conduct

• Marketing to public at a national level on the merits of clinical research

CTSA as a Testing Ground for New Models of Review

Grant Year One:• Initiation of an Alternative IRB workgroup

• First meeting of the regulatory workgroup of the 2006 CTSAs

Grant Year Two:• Project development for Alternative IRB workgroup

• Regulatory workgroup to begin projects

• Metrics of study implementation timelines to be collected

Long-Term Regulatory Goals for the CTSAs

• Regulatory training of clinical investigators and staff

• Best practices in the protection of human subjects participating in research

• Promote clinical and interdisciplinary research by streamlining the initiation and regulatory process