20
Mar2014

by Stephanie Pyle, MFA, Manager of Community and Communications, Schulman Associates IRB

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership established “to identify and promote practices that will increase the quality and efficiency of clinical trials.” While CTTI has several ongoing improvement initiatives, which you can learn more about on their website, a workshop at the 2013 AER Conference, which was held November 7-9 in Boston, focused on their efforts in the IRB space.

During the workshop, titled An Update on the Clinical Trials Transformation Initiative (CTTI) Central IRB Project, Sara Calvert, PharmD, senior clinical project manager for CTTI, and Cynthia Hahn, CTTI Steering Committee member, discussed the results of CTTI’s research into the barriers to adopting centralized IRB review. The results of which have led CTTI members to establish specific recommendations for solving these issues. The presenters also provided resource documents to attendees, some of which are available online.

Through their research, CTTI discovered that some basic clarification is needed regarding the term “central IRB”—many people they spoke with believed the term “central IRB” only referred to commercial IRBs. CTTI feels a more appropriate definition is “a single IRB of record for a given protocol.”

Some of the common barriers CTTI uncovered include legal and regulatory concerns, the review quality of external IRBs, local context considerations, financial limitations, and administrative/logistical issues related to the work of establishing and maintaining a central IRB relationship. They found common themes in the conflation of IRB responsibilities and institutional responsibilities, as well as in institutional discomfort with centralized review due to lack of experience.

Based on these research findings, the presenters offered the following recommendations:

  • A central IRB should be used to improve quality and efficiency in multi-site research.
  • CTTI’s Considerations Document should be used to help unblur the lines of responsibility.
  • Sponsors should require the use of central IRBs to help foster greater comfort and trust with the central IRB model

The presenters also suggested viewing the relationship as not just involving the investigator and the IRB, but also the institution and the IRB. They advocated establishing a successful reliance on a central IRB, which involves employing the following change-management techniques:

  • Assessing institutional culture
  • Establishing goals and deliverables (i.e., making a plan)
  • Identifying potential champions, naysayers, and everyone in between
  • Involving stakeholders early and often
  • Reporting regularly on progress

They proposed evaluating a central IRB by looking at the IRB’s standard operating procedures, its regulatory history, its review experience, and board members’ expertise. They also mentioned it can be useful for institutions to ask sponsor organization if they can review their IRB evaluation criteria.

In using a central IRB, the speakers emphasized that an institution isn’t doing away with IRB review; so much as they are putting together a quality program. They recommended referencing the Association for the Accreditation of Human Research Protection Programs’ information regarding the distinctions of a quality program for more information. They felt that by using a central IRB for some research, a human research protections program becomes more customer friendly, able to consult with investigators on protocols, and can help investigators win more grants.

I’m thrilled that CTTI is committed to finding new ways to improve clinical research quality and efficiency, and I am look forward to hearing more from this motivated group of experts. What do you think?

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