Single IRB

CTTI Heads to ACRP 2015 to Discuss Central IRBs, Accelerating Antibacterial Drug Development, and More

Posted on by Lorri Bingham

On April 25-28, 2015, the single largest gathering of clinical research professionals in North America, ACRP 2015, will take place in Salt Lake City, Utah. CTTI will be presenting at several events throughout the conference to share our evidence-driven, actionable solutions to the barriers of clinical trial efficiency and quality. We look forward to connecting with our colleagues at the following events:

Presentation: Streamlining protocols for operational efficiency: HABP/VABP trials for unmet need (Poster)
Date: April 25, 2015 from 1:30 – 2:30 PM
Presenter: Sara Calvert (CTTI)

Presentation: Mobile Technology and Clinical Research (Panel)
Date: April 26, 2015 from 8:30 – 10:30 AM
Presenters: Matt Harker (CTTI), Corey Bridges (LifeMap Solutions), Solomon Abiola (University of Rochester)

Presentation: CTTI use of central IRBs for multicenter clinical trials (Concurrent Session)
Date: April 27, 2015 from 8:30 – 9:30 AM
Presenters: Sara Calvert (CTTI), Cynthia Hahn (Feinstein Institute for Medical Research), Soo Bang (Celgene)

Presentation: Strategies to Increase the Efficiency of Good Clinical Practice (GCP) Training (Concurrent Session)
Date: April 27, 2015 from 11:00 AM – 12:00 PM
Presenters: Jonathan Seltzer (ACI Clinical)

For a complete list of upcoming events for CTTI, click https://ctti-clinicaltrials.org/upcoming-events/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.

NIH Encourages the Use of Central IRBs in Multi-Site Clinical Trials and CTTI’s Tools Can Assist with Implementation

Posted on by Lorri Bingham

Yesterday, the NIH issued a draft policy encouraging the use of single Institutional Review Boards (IRBs) in all NIH-funded multi-site clinical trials. The rationale behind this new policy was spelled out simply:

When regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Multi-site studies often are able to recruit more individuals from diverse populations and generate important results in less time. However, working through IRB review at each site can add delay without increasing the ethical protections for the research participants in the study. (NIH Clinical Research Policy)

CTTI’s Central IRB Project came to similar conclusions. One of the key takeaways from this project was that sites could become more comfortable using this streamlined review model if government and commercial sponsors required the use of a single IRB as a condition for participating in a particular multi-center trial. We are pleased to see a policy in accordance with our recommendations, and that CTTI’s work was cited. We are confident that these steps will improve the efficiency of clinical trials in the US.

In their concluding remarks, the NIH points out some of the potential hurdles for adopting their guidance:

Despite enthusiasm for central IRBs, there is confusion about the optimal structure for central IRBs as well as how best to meet regulatory requirements. There are questions about the loci of responsibilities and whether the IRB or institutions will bear the blame if adverse events occur. (NIH Clinical Research Policy)

Serious adverse event reporting of is one of the items discussed in the CTTI-developed guide, known as the Considerations Document. The guide can be used by institutions and central IRBs when negotiating legal and ethical responsibilities for multi-center clinical trial.

CTTI Among the Spotlighted Consortia Focused on Drug Development Challenges

Posted on by Lorri Bingham

The latest issue of Nature Reviews Drug Discovery highlights several consortia that have resulted from the FDA’s Critical Path Initiative, launched nearly a decade ago. CTTI is among these initiatives and was featured in the article, The Clinical Trials Transformation Initiative: innovation through collaboration.

This publication explains the crisis in the clinical trials enterprise and CTTI’s unique role in developing actionable solutions. Several CTTI project are highlighted, including Quality by Design, Central IRB, and Investigational New Drug Safety Reporting. For each of these projects, the authors identify the issue at hand and go on to explain CTTI’s efforts to implement recommendations, noting both the difficulties and imperative of creating cultural and organizational change. The authors also comment on the ability of CTTI’s evidence-based work to inform policy and practices in the interest of public health.

“By creating an environment of trust, we enable the stakeholders — representing all sectors of the enterprise — to think about practical solutions to the identified problems and to develop strategies to effect change.”
– Pamela Tenaerts, Leanne Madre, Patrick Archdeacon, and Robert Califf

Ethicist Dr. Felix Gyi Remembered for his Commitment to Human Subjects Protection

Posted on by Lorri Bingham

We are saddened by the unexpected passing of Dr. Felix A. Khin-Maung-Gyi, executive chairman and founder of Chesapeake Research Review LLC.

Dr. Gyi’s contributions to CTTI and the greater clinical trials community will not be forgotten. As an ethicist specializing in clinical research, he was both well respected and passionate about human subjects protection. In addition to establishing Chesapeake IRB, he also served as a member of CTTI’s Steering Committee and was instrumental in spearheading CTTI’s Central IRB Project as a team lead.

The CTTI staff send our condolences to Dr. Gyi’s family, friends and colleagues.

“Felix Gyi will be remembered at CTTI for his enthusiastic efforts to catalyze our first IRB Project. We will all miss his passion and contribution to the clinical trials community.”

-Pamela Tenaerts, CTTI’s Executive Director

CTTI Presents at the SCT 35th Annual Meeting

Posted on by Lorri Bingham

On May 18-21, 2014, the Society for Clinical Trials (SCT) will be hosting the SCT 35th Annual Meeting in Philadelphia, PA. This meeting is intended for a wide range of professionals representing academia, the pharmaceutical and device industries, government agencies and medical groups and centers. We are pleased to announce that CTTI will be present at this conference to share the ideas and lessons generated from several CTTI projects:

  • Team Lead for CTTI’s Central IRB Advancement Project, Cynthia L. Hahn will be presenting in Invited Session 8: Using a Centralized IRB Review Process in the Conduct of Multi-center Trials.
  • CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake will be presenting in Invited Session 14: NINDS INSPIRE Workshop: Patient Engagement & Patient-Centeredness – A Holistic Approach to Clinical Trial Design & Implementation. Key points for this session are related to CTTI’s Patient Groups & Clinical Trials Project.
  • Bray Patrick-Lake will also be part of a team leading a pre-conference workshop on May 18, 2014. This half-day workshop (Workshop P7) will take place from 1:00 PM – 5:00 PM and will cover the Best Practices and Innovations in Patient and Community Engagement in Clinical Trials. Advance registration and payment are required for pre-meeting workshops. CLICK HERE to complete the registration form for the SCT 35th Annual Meeting.

We look forward to connecting with the presenters and attendees of the SCT 35th Annual Meeting. Together, we can facilitate change in the clinical trials enterprise.

INNOVATION THROUGH COLLABORATION

If you are attending this conference and active on Twitter, here’s what you need to know:

Rethinking Clinical Research: Central IRB Advancement Webinar

Posted on by Lorri Bingham

On Friday April 25, 2014, the NIH Collaboratory’s free webinar series known as the Grand Rounds: Rethinking Clinical Research will host the web conference titled CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives. The focus of this webinar will be the adoption of a single IRB of record for multi-center clinical trials, as encouraged in CTTI recommendations. Two speakers, both of whom serve as team leads for CTTI’s Central IRB Advancement Project, will be featured:

  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
  • Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

We invite you to attend this presentation, and encourage you to share this opportunity with your colleagues.

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

Webinar Login:

  1. Log in to the URL first: https://dukemed.webex.com/dukemed/j.php?MTID=m30760324061a749812cd1c966d1bfde0
  2. Click “Audio Conference”
  3. Choose “I will call in” and select the Toll Free number.
  4. Dial in using the information from the dialog box that appears. Be certain to use the Access Code AND the Attendee ID.

*Note: If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 739 773 050
Meeting Password: 1234

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

We would like to thank Cynthia Hahn, Petra Kaufmann, and the rest of the Central IRB Advancement Team for their dedicated efforts to encourage implementation of CTTI’s recommendations. It is through these dissemination activities that methods to increase the quality and efficiency of the clinical trials enterprise are shared, and changes in practice are effected.