This is our fourth entry reviewing webinars about central IRBs from the Clinical Trials Transformation Initiative (CTTI) . This time, we’re looking at Sponsors’ Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States, a webinar from October 2013.
- Cynthia Hahn is Vice President of Clinical Research and Regulatory Affairs at the North Shore-LIJ Health System in New York.
- Soo Bang is Senior Director of Business Development & Global Alliances at Celgene Corporation
- Petra Kaufmann, M.D., M.Sc. is Director of the Office of Clinical Research at the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH).
The presentation started with CTTI’s research into the use of central IRBs, and then shared sponsor-level observations about studies that relied heavily on central IRBs.
Sponsors Should Encourage the Use of Central IRBs
Cynthia noted that some AMCs have not used central IRBs for multisite clinical studies, even though regulatory agencies are encouraging them to do so. Through interviews and analyses, CTTI identified some common obstacles among AMCs:
- Regulatory concerns: Will a central IRB follow all of the rules?
- Quality assurances: How can we be sure the central IRB will conduct acceptable oversight?
- Logistics: How can administrators and researchers manage new forms and procedures?
- Local Context: Will the central IRB understand our unique circumstances well enough?
- Financial: Will we still have enough funds to support out internal operations?
The CTTI team then refined these themes into two core issues:
- “Conflation” of responsibilities (That is, an AMC’s internal IRB often assumes duties beyond what an IRB from the outside would do); and
- Unfamiliarity with working with central IRBs
Blogger’s Note: Another CTTI webinar, Research Institution Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States (which we recently discussed), considers these issues from the hospital’s viewpoint.
From these concerns, CTTI reached three essential conclusions:
1. AMCs should use central IRBs whenever possible, to learn about working with them;
2. CTTI’s online resources can provide important guidance; and
3. Sponsors of research should require central IRB review whenever possible.
The next two speakers took up this last topic, providing examples of how private and public sponsors might convince more AMCs to use central IRBs.
Sponsors Can Boost Confidence in Central IRBs
Soo Bang said private sponsors (such as pharmaceutical companies) can take specific steps to raise confidence in the IRBs they select for multisite studies:
- Sponsors should consider only IRBs that have accreditation;
- IRB selection should be thorough and fair; and
- The sponsor should conclude clear, formal agreements with their IRB of record.
These actions can refute preconceptions that private sponsors “don’t care” about IRBs as well as help preserve the integrity of ethical reviews of research. Sponsors also can use the central IRBs they have selected for outreach, education, and feedback.
Blogger’s Note: the speakers preferred the term “single IRB of record” over “central IRB.” A single IRB of record is one that oversees the same research protocol across a number of locations, and can be an independent IRB, an IRB from another AMC, or federally-funded.
NeuroNEXT’s IRB Attracts 25 Sites
Petra Kaufman shared her experiences with a single IRB of record in NeuroNEXT, a collaboration of 25 clinical sites around the United States. For that Phase II research program, the National Institute of Neurological Disorders and Stroke (NINDS) authorized an IRB from Massachusetts to oversee the research and, in the end, every site in the program signed on with it. Petra said that having one IRB for 25 locations did make research more efficient overall. The single IRB of record prevented redundancies, and helped the study begin more quickly. She added that most stakeholders at the institutions supported a “streamlined” IRB process.
Questions and Answers from the Audience:
- If a research site has its own IRB, can it still transfer review to central IRBs?
Yes, it is possible, many sites are doing so, and interest is growing. CTTI has some data about study startup metrics for local vs. central IRBs. A fundamental question for an AMC to consider: Do sites understand the processes necessary for working with an external IRB?
(Blogger’s note: Check out the results of a pilot program at UNC Chapel Hill that compared central to local IRB review)
- How can a central IRB overcome concerns about understanding local context?
A central IRB might ask for any information, or an AMC can provide any important local content proactively. Experience shows that institutions are most concerned about practical issues such as the availability of transportation or local laws that create unique requirements.
- What about using central IRBs in other countries?
Soo Bang’s project (Celgene) did look at an IRB’s presence in Canada. CTTI’s focus has been on US-based research, but international research could be the ‘next frontier’ for central IRB review.
- Where could someone get more information?
CTTI continues to collect best practices templates and tools, and they are looking for ways to standardize how AMCs establish relationships with central IRBs.
What do you think? Can central IRBs help AMCs and sponsors improve the conduct of clinical trials? Should sponsors require central IRB review, even at an AMC that has one or more IRBs in place? Have CTTI’s presentations provided useful information about central IRBs?
Tags: AMC, Canada, Celgene Corporation, Central IRB, CTTI, National Institute of Neurological Disorders and Stroke, National Institutes of Health, NeuroNEXT, NIH, NINDS, North Shore – LIJ Health System, Quality assurance, Regulatory, Sponsors, webinar