Download the Recommendations

In addition to the recommendations, a suite of tools have been developed to assist with implementation:

• Interactive Selection Tool: Excel document for discerning between viable novel endpoints for development
• Flowchart of Steps for Novel Endpoint Development: Flowchart summarizing the process of developing a novel endpoint, generated by mobile technology, for use in clinical trials
• Detailed Description of Steps for Novel Endpoint Development: Table providing a detailed description of the steps for novel endpoint development, including suggested approaches, considerations and links to tangible examples in the use cases
• Quick Reference Guide: Guide to processes for interacting with the FDA regarding novel endpoint development
• PowerPoint Slide of Positive Impacts: Use this ppt slide in your presentations (Note: This information is also included in the first page of the Recommendations.)
• Uses Cases for for developing novel endpoints generated using mobile technology:
  • Diabetes Mellitus
  • Duchenne Muscular Dystrophy
  • Heart Failure
  • Parkinson’s Disease

These CTTI recommendations are meant to help researchers design trials that are less burdensome for families, as well as to support improved practices for approaching parents for consent during the stressful time of a child’s illness. These recommendations are based on research that showed 80% of clinicians surveyed identified parent concerns about their child participating in research to be a barrier for completing research studies with children. This emphasizes the need for better engagement with parents throughout a clinical trial, including during the initial design stage.

Additionally, the following tools were developed in tandem with the official Recruitment Recommendations. These tools are linked to in the recommendations document, and are also listed below for convenience.

1. Tool #1. Decision Tree
   A helpful decision-making aid to use when engaging with stakeholders in study design & development
2. Tool #2. Stakeholder Identification and Analysis Tool
   A resource to help you identify and engage with stakeholders
3. Tool #3. Monitoring Recruitment Process and Performance
   A tool to assist in considering how to monitor recruitment process and performance
4. Tool #4. Special Note on Patient Reported Outcomes (PROs)
   A guide when considering whether and/or how to include PROs in your study

Primary Users: Research Sites, Research Coordinators and Investigators, Research Sponsors, CROs, IRBs, Patients

The following tools were developed to assist researchers (at the site and sponsor) in using CTTI's recommendations to improve the informed consent process. These tools, which are included as appendices of the recommendations document, are available below in editable formats that may be customized to meet your organizational needs.

1. Tool 1. Informed Consent Discussion Tool (Word)
   Researchers can use this tool to guide conversation during the consent process, ensuring the specific needs of each study participant are considered, key elements of the trial are reviewed and addressed, and interactive techniques are used to facilitate participant understanding of the information imparted. This tool could be used for documenting the informed consent process, but should not be viewed as a regulatory compliance document.
2. Tool 2. Informed Consent Training Resources (Word)
   Research sites can use this tool to evaluate external informed consent training resources to determine if the resource meets the needs of the site’s training program.
3. Tool 3. Sample Tiered Informed Consent Model (Word)
   Research sites, research sponsors, CROs, and IRBs can use this tool to better understand the basic structure of the Tiered Informed Consent Model document. It is not intended to be an informed consent document template.

Primary Users: Anyone interested in designing and conducting clinical trials

This project identified a need among clinical researchers for resources to support establishing and sustaining Quality by Design (QbD) within their organizations. To address this need, CTTI has developed a QbD toolkit that includes resources for researchers first learning about QbD concepts, to those who are ready to fully implement QbD into a clinical trial. Components of the toolkit include 1) an introduction to QbD concepts, 2) tools for teaching others in your organization about QbD and its use, and 3) tools for operationalizing QbD in your next clinical trial, including an interactive QbD Principles Document, a description of principles for building quality into trials, intended as a tool for inquiry in “critical to quality” factors (CTQs) and associated risks.