Ethics

NEW Publication: CTTI Convenes Expert Panel that Identifies 3 Topics Ripe for Reform

Posted on by Lorri Bingham

This week, Clinical Trials published Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel. This publication is the result of CTTI’s Informed Consent Project and is based on the expert interviews conducted with stakeholders who have long-standing experience with the informed consent process. The goal of these interviews was to identify limitations within the current informed consent process and actionable recommendations for change. Three major themes emerged from these interviews, namely reform of the informed consent document, enhancing participant understanding of the clinical research, and modification of IRB review.

“The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations.”
-B. H. Lorrell, et al.

Figure 1. Enhancing research participant understanding of a clinical trial. Derived from authors’ analysis of results from 25 interview transcripts.

TO READ THE PUBLICATION IN FULL, CLICK HERE.

CTTI’s IND Safety Advancement Project Presents at 7th Annual AACI Conference

Posted on by Lorri Bingham

On July 8-9, 2015, the Association of American Cancer Institutes (AACI) will host their 7th Annual AACI Clinical Research Initiative Meeting in Chicago. The results of CTTI’s IND Safety Advancement Project survey and interviews will be featured in the session titled, How Do Cancer Centers Ensure Patient Safety when Conducting Clinical Trials? The goal of this CTTI project is to increase compliance with respect to assessment, communication, review, and management of expedited IND safety reports. We look forward to this opportunity to share our work with colleagues.

Are you interested in safety reporting in clinical trials? Click here to read CTTI’s recommendations that resulted from our original IND Safety Project.

#DIA2015 Wrap-Up: CTTI Conference Materials Available Online

Posted on by Lorri Bingham

The DIA’s 51st Annual Meeting earlier this month was a great success. In addition to presenting preliminary findings from several CTTI projects, we also unveiled the official recommendations and associated Toolkit from our Quality by Design (QbD) Project. We’d like to thank all of our colleagues who came together for a week of engaged discussion and learning.

We are now happy to share the materials from CTTI’s presentations. We hope you find them useful in your efforts to improve the quality and efficiency of clinical trials.

DIA SESSION: CLINICAL QUALITY BY DESIGN: FROM THEORY TO PRACTICE

DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS

 

DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE

 

DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS

 

DIA POSTER: RESULTS OF AN ONLINE SURVEY OF STAKEHOLDERS REGARDING BARRIERS AND SOLUTIONS TO CLINICAL TRIAL RECRUITMENT

  • CLICK HERE to view a PDF of this poster.
  • CLICK HERE for more information on CTTI’s Recruitment Project.

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.

Expert Meeting Summary Available: Multi-stakeholder Perspectives on Improving Informed Consent

Posted on by Lorri Bingham

Key stakeholders in the clinical trials enterprise acknowledge that informed consent documents are too lengthy and difficult for research participants to understand, and the informed consent process is not meeting the needs of the participants; however, there is currently little consensus around what a more effective informed consent model should look like. Actionable recommendations are needed, and CTTI is working to address this unmet need.

In March CTTI convened a multi-stakeholder group of experts and thought leaders from across the clinical trials enterprise to explore more effective informed consent processes. Specifically, the meeting attendees set out to:

  • Discuss previous and current efforts to improve informed consent documents and the informed consent process, including alternatives to the traditional paper informed consent document
  • Identify potential remedies for concisely communicating the required elements of informed consent, including how consenter training affects the informed consent process
  • Propose a more effective process, including informed consent documentation, for ensuring research participants’ understanding of critical informed consent elements
  • Suggest potential strategies and opportunities for pilot testing the informed consent process improvement recommendations

We are pleased to share the summary, as well the presentation materials from this expert meeting. These materials describe the current challenges involved with the consent process and provide an evidence-based foundation for moving forward.

Click here to view all meeting materials.

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.

Latest CTTI Recommendations Address Desired Attributes of Electronic Portals for Expedited Safety Reporting

Posted on by Lorri Bingham

A CTTI survey identified that investigators and research staff believe electronic portals have the potential to increase the efficiency of expedited safety reporting to research sites, but in practice are difficult to use and add to the complexity of the system.

CTTI’s IND Safety Advancement Project Team developed recommendations for Desired Attributes of Electronic Portals for Expedited Safety Reporting to help mitigate these issues for those involved in safety reporting.

DOWNLOAD THE RECOMMENDATIONS

We encourage you to share these recommendations with your colleagues involved in safety reporting. Together, we can build a better system and overcome #hyperportalosis.

 

Hyperportalosis | noun

  1. Frustration resulting the need to interact with a variety of incompatible, inconsistent and non-intuitive electronic portals
  2. A maddening state commonly experienced by clinical investigators marked by compulsive desires to hit one’s computer(s)