Author: Hannah Faulkner

New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care

Posted on by Hannah Faulkner

Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication of activities that already occur in clinical care. However, there are currently no guidelines or strategies to help clinical trial stakeholders operationalize this fit-for-purpose integration.

To remedy this issue, CTTI is starting work on a new project that will result in data, resources, and recommendations aimed at bridging the gap between trials and clinical care settings to improve evidence generation. This project aims to:

  • Identify when elements of interventional clinical trial integration into clinical settings would be feasible and the associated benefits and risks
  • Identify barriers and potential solutions to incorporating interventional trials into clinical care
  • Describe operational approaches to incorporating interventional trials into clinical care

CTTI will develop the new recommendations by conducting in-depth interviews that identify barriers and solutions with a wide variety of clinical trial and healthcare experts, compiling case studies on innovative operational approaches, and organizing a multi-stakeholder meeting to discuss strategies.

By taking a multifaceted approach, CTTI aims to create resources that will help clinical trial stakeholders overcome the barriers to integrating interventional research into real-world settings to create more relevant results.

New CTTI Steering Committee Positions Open for Patient/Caregiver Representative

Posted on by Hannah Faulkner

One of many ways that CTTI engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. Now, through 11:59 p.m. ET, Sun., Nov. 22, we are accepting applications for this position. We are looking for patients or caregivers who are self-starters, have personal experience and familiarity with clinical trials, and can work with stakeholders across the research community.

During their three-year term, CTTI Steering Committee patient/caregiver representatives contribute ideas for projects, participate in their conduct and analysis, and are committed to disseminating CTTI recommendations and encouraging adoption of system changes that will improve the efficiency of clinical trials.

Learn more about the opportunity and apply today.

CTTI to Release New Resources for Adoption of a Quality by Design Approach During Nov. 12 Webinar

Posted on by Hannah Faulkner

CTTI will host a public webinar, Accelerating Evidence Generation: New CTTI Resources for Implementing a QbD Approach to Clinical Trials, on Thurs., Nov. 12.

“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing, and thus demonstrating the value of Quality by Design,” said CTTI Executive Director Pamela Tenaerts, MD, MBA. “These new tools aim to help researchers implement QbD into their trial – an efficient approach that will help them focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.”

The specific resources that CTTI will release include:

  • QbD Maturity Model: This self-assessment tool can be used by organizations to assess their current implementation of QbD, and to identify a desired future state.
  • Metrics Framework: This QbD Metrics Framework provides nine example metrics that can help key stakeholders in clinical research organizations to self-evaluate QbD implementation and guide continuous improvement efforts.
  • Implementation Guide: This resource helps study teams plan and evaluate their implementation of QbD for an individual clinical trial, and is intended to serve as a guide to key elements of QbD that will often be important to incorporate in trial planning and execution.
  • Documentation Tool: This tool helps study teams capture and communicate decisions about what is critical to quality and how the most important risks will be addressed.

These new resources expand CTTI’s existing QbD toolkit, which serves as a one-stop-shop for any individual or organization looking to implement QbD, and may help meet the anticipated new guideline for ICH E8(r1), which is expected to be finalized in 2021 and emphasizes a QbD approach to trial design.

The free public webinar will begin at noon EST on Thurs., Nov. 12 and will feature the following presenters:

  • Greg Pennock, EMD Serono
  • David Rodin, Amici Clinical Research
  • Karlin Schroeder, Parkinson’s Foundation
  • Ansalan Stewart, FDA
  • Steve Young, CluePoints

Recording Now Available: CTTI’s New Robust Set of Resources to Assist with Designing and Running Master Protocols

Posted on by Hannah Faulkner

A recording is now available of the public webinar held on Tues., Oct. 13, to launch CTTI’s new set of resources that can be used to collaborate, communicate, and design master protocol studies. The webinar was led by Abby Bronson, Edgewise Therapeutics; Marianne Chase, Massachusetts General Hospital; Daniel Millar, Janssen R&D; and Nick Richardson, FDA, CDER.

While the interest in master protocol studies is growing, many organizations—particularly non-traditional drug developers such as patient advocacy groups and other nonprofits—lack the experience to design and implement this kind of study. In response to these challenges, through a high-level landscape review, a series of expert meetings, and a public open comment opportunity, CTTI developed a set of resources that include frameworks, case studies, and other interactive materials to assist in the planning and development of master protocols.

“With the success of master protocols in COVID-19 trials, there’s never been a better time to rethink the way you’re doing clinical trials in other disease areas,” said Pamela Tenaerts, executive director at CTTI. “In many cases, a well-designed and well-planned master protocol approach is an ideal way to get answers to scientific questions faster and serve patients better. Our new set of resources give sponsors, non-profit groups, and others a starting point and pathway for designing and conducting a successful master protocol study from start to finish in your disease area.”

The specific resources that CTTI released in conjunction with this webinar include:

  • Value Proposition Guide: outlines key considerations for presenting the value proposition of the master protocol to stakeholders such as collaborators and vendors
  • Study Simulation Tool: provides an overview of key modules that should be simulated in order to optimize master protocol design
  • Protocol Development Map: describes the unique aspects of developing a master protocol from the academic or nonprofit organization perspective
  • Operations Partner Assessment Tool: outlines considerations for engaging and selecting vendors as partners in master protocols
  • FDA Engagement Tool: describes the formal mechanisms that facilitate early interaction with the FDA and provides a general timeline for development of an FDA engagement strategy

Both the webinar and latest resources can be found on the CTTI website.

CTTI Paper Features Tool to Help Sponsors and Patient Groups Identify Mutually Beneficial Opportunities for Collaboration

Posted on by Hannah Faulkner

Effective engagement between patient groups and research sponsors can enhance the quality and efficiency of clinical trials, improve patient recruitment and retention, reduce costs, and speed the pathway toward new medical treatments. One opportunity for sponsors is to identify and prioritize new effective engagement activities. A new manuscript in Therapeutic Innovation & Regulatory Science details CTTI’s evidence-based prioritization tool to help sponsors and patient groups pinpoint mutually beneficial engagement activities.

The web-based tool provides 24 unique engagement activities that span the medical product development lifecycle. Using a three-step decision-making process, the tool helps sponsors and patient groups define the expectations, goals, and important roles that will have the biggest impact on the design, conduct, and dissemination of clinical research. The findings help teams apply CTTI’s recommendations for effective patient group engagement by supplying the results in an easy-to-use visual priority matrix grid.

Read the full manuscript.

Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The two-day Pan-American web conference was held June 4-5 with more than 1300 attendees worldwide.

The report provides an overview of the presentations from a diverse group of participants, including academic researchers, human subject protection and ethics experts, as well as patients. Members of the ICH Expert Working Group (EWG), which is tasked with updating the ICH E6 guideline, provided an overview of their approach to ensuring that the guideline is responsive to the needs of the community and that it facilitates advances in clinical trial design and conduct. The report also outlines key themes from the web conference’s line-up of stakeholders who shared their experiences with ICH E6(R2).  Further, the report also incorporates comments and input from web-conference attendees that were received via email or verbally during the web conference.

Check out the recording and the slide decks for each day of the web conference to learn more from the presenters.

For additional information on the ICH E6 revision efforts, please refer to the following materials: