Formats Archives - Page 54 of 109

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

Posted on October 27, 2020March 5, 2025 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 October 22, 2020August 10, 2021 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 October 20, 2020March 5, 2025 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: