Single IRB

CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

Posted on by Lorri Bingham

The NIH has selected CTTI to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.

 

“For nearly a decade, CTTI has championed the adoption of sIRBs for multicenter clinical trials,” said Pamela Tenaerts, executive director at CTTI. “We are excited to use our expertise to craft an evaluation plan for the NIH policy, and to design standard evaluation methods that can be used by academic organizations, research sponsors, and others who are interested in implementing sIRBs.”

 

Sites in multicenter clinical trials have typically relied on their own IRBs to conduct required ethical reviews, often leading to needless repetition across sites. The goal of the NIH’s new sIRB policy is to enhance and streamline the review process for multicenter studies so that research can proceed as quickly as possible and research oversight may be improved.

 

CTTI has developed a number of recommendations and resources to support sIRB adoption, and the NIH referenced CTTI’s work in a 2014 draft policy recommending the use of sIRBs. Currently, CTTI is gathering information from sponsors, investigators, IRB members, and research and regulatory coordinators to determine actions that the NIH, the FDA, and the Office for Human Research Protections can take to help the research community adopt sIRB review.

CTTI Continues to Address Barriers to Single IRB Adoption: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Using a single institutional review board (sIRB) for multisite trials can improve the quality and efficiency of multicenter clinical trials—and beginning Jan. 25, 2018, the National Institutes of Health (NIH) is requiring use of an sIRB for NIH-funded multicenter clinical research.

To help drive adoption of sIRB review, CTTI has developed several recommendations, resources, and tools for use by the research community, and recently convened an expert meeting to discuss further actions that CTTI, the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and NIH can take to ease the transition. The expert meeting included representatives from academia, government agencies, IRBs, pharmaceutical, and device companies, contract research organizations, and patient groups, with the goal of identifying remaining gaps in knowledge and potential solutions to implementing a sIRB model.

Meeting participants highlighted the need for clarity around language and procedures, and emphasized that early collaboration among parties can mitigate the challenges. Participants felt that the time is right to learn from each other by sharing successful models of sIRB review among the private sector, academia, and government research organizations. Next steps from CTTI will involve new projects and committees to develop additional supportive tools and strategies for implementing sIRB review.

Four Key Areas Where CTTI Has Transformed Clinical Trials

Posted on by Lorri Bingham

This year, CTTI marks its 10th year of working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused. To commemorate this milestone, we will #CelebrateCTTI throughout the month of January. Join us for the celebration—visit this blog, follow us on Twitter, and register to attend our 10 Year Anniversary Symposium on Tues., Feb. 6.

Since its inception in 2007, CTTI has made transformational shifts in the design and conduct of clinical research. Let’s take a look at the evolution of clinical trials in four key areas, among many, in which CTTI has played a critical role in moving the industry toward more efficient, high-quality, and patient-centric trials:

Trial Quality

Regulators have long acknowledged a need to change how the industry approaches clinical trial quality in order to focus on reducing errors that undermine data integrity and patient safety. Drawing on the expertise of key stakeholders, CTTI issued recommendations on effective and efficient trial monitoring in 2012. The following year, FDA issued final guidance on a risk-based approach to monitoring, reflecting principles from CTTI’s work. CTTI also developed the concept of Quality by Design, taking the focus from a reactive approach using audits to a proactive approach that builds quality into clinical trials at the outset. CTTI released its Quality by Design recommendations and toolkit in 2015, and its work in this area has been cited in FDA guidance and incorporated into GCP guidelines.

Patient Engagement

CTTI has been a pioneer in patient engagement, involving patient representatives in its organizational leadership and throughout its project teams. Spurred by the FDA’s Safety and Innovation Act of 2012, CTTI initiated the Patient Groups & Clinical Trials Project to establish best practices for engaging patients in clinical research. In 2014, CTTI released landmark recommendations that are currently used by multiple stakeholders to facilitate productive relationships with patient groups around clinical trials. In 2017, CTTI and FDA announced a partnership on a new initiative, the Patient Engagement Collaborative, to improve patient engagement across the FDA.

Central IRB

Although U.S. regulators are enthusiastic about the use of a central IRB to promote more efficient multi-site clinical trials, enterprise-wide implementation has lagged. CTTI initiated the Central IRB Project in 2010, creating recommendations and resources to help organizations identify and address barriers to the adoption of a central IRB. The NIH issued a draft policy in 2014 referencing CTTI’s recommendations and a final policy in 2016 requiring all NIH-funded multi-site clinical trials to use a central IRB effective in 2018.

Real-World Evidence

Since its inception, CTTI has recognized that “real-world evidence” from electronic health records, mobile devices, and other sources can provide unique insights into important clinical questions and could improve the efficiency of clinical trials. The FDA Amendments Act of 2007, which mandated FDA to develop a system to link safety data from multiple sources, paved the way for the use of connected datasets in clinical trials. After partnering with the FDA and Harvard Pilgrim Health Care Institute to assess the feasibility of using the Sentinel database for clinical research, CTTI supported the first trial using Sentinel. CTTI also launched a program in 2016 to support the use of mobile technology in clinical trials, issued recommendations in 2017 on how to use registries as reusable platforms for trials, and announced a Real-World Evidence Project in 2017.

New NIH Policy Aligns With CTTI’s Work to Increase Adoption of Central IRBs

Posted on by Lorri Bingham

The NIH has issued a final policy requiring the use of a single institutional review board (IRB) for multi-center NIH-funded clinical trials. The policy will take effect May 25, 2017.

Since 2010, CTTI has been working to address barriers to the adoption of central IRBs for multi-center clinical trials through its Central IRB and subsequent Central IRB Advancement projects. The draft NIH policy released in 2014 referenced CTTI’s recommendations, and the final policy reflects CTTI’s shared goal to increase the efficiency of clinical trials through the use of central IRBs.

With the NIH mandate now finalized, CTTI’s tools are available to help with implementation. These include the following:

  • a template IRB authorization agreement
  • an evaluation checklist with considerations for 1) assessing an institution’s readiness for central IRB adoption, 2) selecting a central IRB, and 3) deciding when a central IRB should work with a specific institution
  • a considerations document to address the often blurred distinctions between responsibilities for ethics review and other institutional obligations

According to the new policy, “while the NIH anticipates that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of [single IRBs] will outweigh any costs and, ultimately, reduce burdens to the research process.”

CTTI applauds this important progress for the clinical trials enterprise.

 

CTTI’s Recommendations & Implementation Tools for Advancing the Use of Central IRBs to be Featured in Upcoming MDICx Webinar

Posted on by Lorri Bingham

CTTI’s recommendations and implementation tools for advancing the use of central IRBs for multi-center clinical trials will be presented at the next webinar in the MDICx series. The featured speakers include Cynthia Hahn, Chief Operating Officer, The Feinstein Institute for Medical Research, and Soo Bang, Sr. Director, Global Alliances & Business Development, Celgene Corporation.

Webinar Details:

  • Date: Wednesday, August 12th
  • Time: 12:00 p.m. – 1:00 p.m. ET
  • REGISTER HERE

We look forward to this event and encourage the sharing of this invitation with colleagues involved in the clinical trial enterprise.

Recording Now Available: NIH Collaboratory Grand Rounds Features CTTI’s Central IRB Recommendations

Posted on by Lorri Bingham

On July 10, 2015, the NIH Collaboratory’s Grand Rounds Webinar Series featured the work of CTTI’s Central IRB Advancement Project. Co-team leader Cynthia Hahn reviewed the recently released recommendations for advancing the use of central IRBs for multicenter clinical trials.

We are now pleased to share the recording of this webinar:

NIH Collaboratory Grand Rounds to Feature CTTI’s Central IRB Recommendations

Posted on by Lorri Bingham

On July 10, 2015, the NIH Collaboratory’s Grand Rounds Webinar Series will feature the work of CTTI’s Central IRB Advancement Project. Co-team leader Cynthia Hahn will review the recently released recommendations for advancing the use of central IRBs for multicenter clinical trials. We look forward to this opportunity to connect with colleagues and share the results of this project. Please forward this invitation with others interested in clinical triahttps://ctti-clinicaltrials.org/our-work/ethics-andl conduct.

Topic: The Clinical Trials Transformation Initiative’s (CTTI) Recommendations: Advancing the use of central IRBs for multicenter clinical trials

Date: Friday, July 10, 2015

Time: 1:00-2:00 p.m. ET

Speaker: Cynthia Hahn, Vice President, Clinical Research & Regulatory Affairs at North Shore-LIJ Health System, Chief Operating Officer, The Feinstein Institute for Medical Research

Meeting Link:
https://dukemed.webex.com/dukemed/j.php?MTID=m1a4a0665a615ae0382440edecedbdd33

For Audio ONLY:
Call-in toll-free number (US/Canada): 1-855-244-8681
Access code: 739 348 059

For additional webinar details, visit the NIH Collaboratory’s Grand Rounds calendar.

This is the first part of a webinar series co-hosted by the NIH Collaboratory and PCORnet, titled “A Grand Rounds Special Series: Use of Central IRBs for Multicenter Research.”

CTTI Releases New Tools to Help Organizations Implement Central IRBs in Multi-Center Clinical Trials

Posted on by Lorri Bingham

Today the Clinical Trials Transformation Initiative (CTTI) announced new recommendations that support the use of a single institutional review board (IRB) of record for multi-center clinical trials.  Included within the recommendations are tools, such as evaluation checklists, to help sponsors, research institutions and central IRBs implement this model.

In a multi-center clinical trial, full review by each site’s IRB can lead to significant delays in study start-up and may not enhance the protection of research participants.  Since 2010 CTTI has been working to understand and address barriers to using a single IRB of record for multi-center clinical trials in the United States. The project was initiated because some research sites were hesitant to use a central IRB, despite encouragement from the U.S. Food and Drug Administration (FDA) and the U.S. Office of Human Research Protections (OHRP).

“Using a single IRB for multi-site clinical research is an important step in accelerating the translation from discoveries to health benefits. The Clinical and Translational Science Awards (CTSA) program is working toward using a single IRB for multi-site studies. The CTTI Central IRB recommendations will be very helpful in advancing towards this goal,” said Petra Kaufmann, M.D., M.Sc., director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).

In addition to the evaluation checklists, CTTI has released a Considerations Document and an IRB authorization agreement template, to support communication and contractual relationships between institutions and a central IRB. CTTI has also hosted webinars during which individuals from sponsor and research organizations have presented their experience of adopting a central IRB model as examples that others can follow.

A complete list of recommendations can be found here.

CTTI’s Tools for Improving Clinical Trial Quality & Efficiency

Posted on by Lorri Bingham

In our pursuit to enhance the implementation of CTTI’s recommendations, we’ve created a new webpage on our site that we’d like to share with you. This page features CTTI’s three most commonly used tools:

  1. The Considerations Document for a Single IRB of Record: Developed by CTTI’s Central IRB Project, this tool supports communication and contractual relationships between institutions and a central IRB to address blurred distinctions between responsibilities for ethics review and other institutional obligations. Primary users for this tool include sponsors, academic institutions, investigators, IRBs that act as a single IRB of record.
  2. The Quality by Design Principles Document: Developed by CTTI’s QbD Project, this tool helps those working in trials to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality. Primary users for this tool include anyone interested in designing and conducting clinical trials.
  3. The AACT Database: Developed by CTTI’s State of Clinical Trials Project, this tool makes the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Primary users for this tool include researchers interested in analyzing data from clinical trials.

The Tools Page can be accessed on the CTTI site under Briefing Room > Tools. We hope that you find this resource valuable and share with your colleagues in the clinical trials enterprise.