CTTI News

CTTI Director of Stakeholder Engagement Participates in Development & Release of Patient-Centered Framework

Posted on by Lorri Bingham

Today, the Medical Device Innovation Consortium (MDIC) releases their Patient Centered Benefit-Risk (PCBR) Framework. This framework and the accompanying catalog of methods address the incorporation of information on patient preferences regarding benefit and risk into the regulatory assessments of new medical technologies.

CTTI’s Director of Stakeholder Engagement, Bray Patrick-Lake, participated in the development of this framework, and joins colleagues from the National Health Council, Focused Ultrasound Foundation, and FasterCures for the Discussion on Patient Group Perspective during today’s release. This public event is hosted in Washington, DC and attendees are welcomed to join via webinar, as well. For registration information, click here.

“Before approving a new medical device, regulators must evaluate its safety and effectiveness. One of the most important questions they ask is whether the clinical benefit of a device outweighs its risk. It makes sense to consider that question from the perspective of patients as well as researchers and clinicians.”
–MDIC

Bray Patrick-Lake also manages CTTI’s project on Best Practices for Effective Engagement with Patient Groups around Clinical Trials. This project seeks to identify best practices for engaging patient groups that will lead to more efficient and successful clinical trials.

CTTI Welcomes New Members Rexahn Pharmaceuticals and Mark Krueger & Associates, Inc.

Posted on by Lorri Bingham

CTTI would like to welcome newest members Rexahn Pharmaceuticals and Mark Krueger & Associates, Inc.

Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing therapeutics for the treatment of cancer. Chief Medical Officer Ely Benaim will represent this organization on CTTI’s Steering Committee.

Mark Krueger & Associates, Inc. is a consulting firm focused on healthcare constituency relations. Senior Vice President Ellen Coleman will represent this organization on CTTI’s Steering Committee.

CTTI engages all stakeholders to collaboratively improve the quality and efficiency of the clinical trials enterprise. For more information about the diverse representation of CTTI’s membership, click here.

Recording Now Available: CTTI Webinar Provides Real-World Examples of QbD in Clinical Trials (Part 3)

Posted on by Lorri Bingham

Quality by Design (QbD) is an approach to planning clinical trials that involves building quality into the process from the beginning, where quality is defined as the absence of errors that matter to decision-making. While there is growing consensus around the idea that QbD can improve the quality and efficiency of trial design, questions remain about the implementation of these principles.

To address these questions, CTTI’s QbD Project has organized a three-part webinar series, which explores concrete examples of real-world application of QbD Principles. The third and final webinar in this series recently took place on April 15, 2015, featuring speakers from Johnson & Johnson and the University of Oxford who discussed how QbD has been executed within their organizations, as well as the lessons gleaned from their experiences.

We’re happy to share the recording of this webinar, and we encourage you to share it with your colleagues.

To view a recording of the first webinar in this series, click here.

To view a recording of the second webinar in this series, click here.

Mark your calendars for 12:00 PM EST on July 16, 2015! CTTI will be hosting a public QbD webinar to unveil our QbD toolkit. The QbD Toolkit will provide users with resources for:

  1. Promoting QbD concepts in their organization,
  2. Educating colleagues about QbD concepts via case studies, and
  3. Implementing QbD in real trials.

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.

CTTI Annual Report Highlights Achievements in Improving Clinical Trials Enterprise

Posted on by Lorri Bingham

Since our inception, CTTI has been successful at generating evidence and formulating implementable recommendations that inform policy and practice, thus creating positive change in clinical trials. In our 2014 Annual Report, we highlight a number of CTTI’s key achievements in improving trial quality and efficiency, with topics ranging from patient engagement to central IRB adoption. To hear more about how CTTI’s work is impacting operations and culture within organizations such as PCORI, Pfizer, and the FDA, click here.

CTTI Welcomes New Member Alliance for Lupus Research

Posted on by Lorri Bingham

CTTI would like to welcome newest member Alliance for Lupus Research. As a national voluntary health organization committed to finding better treatments for and ultimately curing lupus, they represent one of many key stakeholders that CTTI engages to collaboratively improve the quality and efficiency of the clinical trials enterprise. Executive Director Albert Roy will represent the Alliance for Lupus Research on CTTI’s Steering Committee.

For more information about CTTI’s organizational structure, including the Steering Committee, CLICK ERE.

From Theory to Practice: Advancing QbD in Clinical Trials at Upcoming Partnerships in Clinical Trials Conference

Posted on by Lorri Bingham

Quality by Design (QbD) emphasizes building quality into a process from the beginning. While a broad cross-section of key stakeholders in the clinical trials enterprise agree that the widespread adoption of an enlightened QbD approach to trial planning, conduct, and oversight is needed to ensure trial quality and efficiency, a lack of real-world examples of this process leave many wondering how to move from theory to practice.

To help answer these questions, two members of CTTI’s QbD Project will be presenting at the 24th Annual Partnerships in Clinical Trials Meeting in Boston, MA on April 24, 2015:

Session Title: Clinical Quality by Design – Principles to Practice

Speakers:

  • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, BioResearch Quality and Compliance, Johnson & Johnson Quality and Compliance
  • Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer

Agenda:

  • Develop understanding of Quality by Design (QbD) principles for clinical trials
  • Identify perceived barriers and potential solutions to the adoption of Quality by Design
  • Review opportunities for dissemination of these principles and practices to a broad array of stakeholders

We look forward to connecting with our colleagues at #PCTUS.

If you are interested in hearing more stories of translating QbD principles into practice, please join us during a one-hour CTTI-hosted webinar on April 15.

CTTI Discusses Opportunities & Challenges of Innovation in Clinical Trials in Recorded Podcast

Posted on by Lorri Bingham

On March 31, 2015, CTTI’s Executive Director Pamela Tenaerts and Director of Stakeholder Engagement Bray Patrick-Lake joined other thought leaders to discuss the lengthy process of developing a new medicine and explore new ideas that could drastically change the way clinical trials are conducted. This conversation took place on “Business Reinvention with Nancy Lin,” a broadcast on the VoiceAmerica Business Channel.

A RECORDING OF THIS ONE-HOUR PODCAST IS NOW AVAILABLE ONLINE.

Topics examined include:

Does innovation have to be unaffordable? There is probably nothing that affects more Americans than the increasing healthcare cost in this country. While there were more new drugs approved in 2014 by the FDA than the previous 18 years, many of the new drugs’ prices were staggering. As the baby boomers age, the need for medical breakthroughs to fight disease as well as cost control intensifies. How can we continue to innovate without bankrupting our healthcare system?
–Business Reinvention with Nancy Lin