Official Recommendations

Use of Mobile Technologies in Clinical Research

CTTI Project: Mobile Technologies

In a special event at the U.S. Food and Drug Administration (FDA) on July 16, the Clinical Trials Transformation Initiative (CTTI) unveiled recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

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Strengthening the Investigator Site Community

CTTI Project: Investigator Community

High rates of turnover among clinical site investigators and a shrinking pool of experienced researchers together threaten to harm the efficiency and quality of clinical trials. CTTI has responded to these challenges with actionable, evidence-based recommendations for strengthening and growing the site investigator community.
 

PDF icon investigator_community_recommendations_final.pdf

Planning for Pregnancy Testing in Clinical Trials

CTTI Project: Pregnancy Testing

CTTI's recommendations can help research sponsors, investigators, and institutional review boards create and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials. To help implement the recommendations, CTTI also created the Pregnancy Testing Outcomes Predictor for Clinical Trials, a web application that provides a quantitative method for assessing estimated likely outcomes of different pregnancy testing plans.

PDF icon pregnancytesting_recommendations_final.pdf

Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

CTTI Project: Novel Endpoints

Download the Recommendations

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

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CTTI Recommendations on Registry Trials

CTTI Project: Registry Trials

CTTI’s recommendations for registry assessment and design can assist in making embedded clinical trials suitable for regulatory purposes. By using registries as a reusable platform for evidence generation, we can improve the efficiency of clinical trials and bring new treatments to patients faster.

PDF icon registrytrials-recs.pdf

Improving Pediatric Trials in Antibacterial Drug Development

CTTI Project: Peds Trials

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.

PDF icon abdd-pedstrials-recs.pdf

CTTI Recommendations for Streamlining Protocol Elements for Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) Trials

CTTI Project: Streamlining HABP/VABP Trials

PDF icon CTTI Recommendations for Streamlining Protocol Elements for HABP/VABP Trials

CTTI Recommendations for Optimizing Operational Efficiency for Data Collection in Hospital Acquired Bacterial Pneumonia (HABP)/Ventilator Acquired Bacterial Pneumonia (VABP) Trials

CTTI Project: Streamlining HABP/VABP Trials

PDF icon CTTI Recommendations for Optimizing Operational Efficiency For Data Collection In HABP/VABP Trials

CTTI Recommendations on Data Monitoring Committees (DMCs)

CTTI Project: Data Monitoring Committees (DMCs)

PDF icon DMC Recommendations

CTTI Recommendations on Planning for Successful Trial Recruitment

CTTI Project: Recruitment

MAY 2016; UPDATED JULY 2017

CTTI Project: Recruitment

CLICK HERE to download the full set of these recommendations

The following resources were developed in tandem with the official Recruitment Recommendations.

  1. Decision Tree: How to Optimize Your Protocol Design
    A helpful decision-making aid to use when engaging with stakeholders in study design & development
  2. Customizable Table: How to Identify and Engage with Stakeholders
    A resource to help you identify and engage with stakeholders
  3. Checklist: How to Monitor Recruitment Process & Performance
    A tool to assist in considering how to monitor recruitment process and performance
  4. Considerations: Should I Include Patient Reported Outcomes (PROs) In My Study?
    A guide when considering whether and/or how to include PROs in your study

CTTI Recommendations on Desired Attributes of Electronic Portals for Expedited Safety Reporting

CTTI Project: Safety Reporting

PDF icon Safety Reporting Recommendations

CTTI Recommendations on Informed Consent

CTTI Project: Informed Consent

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.
PDF icon Informed Consent Recommendations

CTTI Recommendations on Effective Engagement with Patient Groups around Clinical Trials

CTTI Project: Patient Groups & Clinical Trials

Primary Users: Patient Groups, Research Sponsors, Investigators, CROs, Research Coordinators and Sites

The following tools were developed to assist research sponsors in assessing patient groups as potential partners in research and development, and to support patient groups in making their relevant assets and expertise transparent to sponsors. These tools, which are included in the appendices of the recommendations document, are available below in editable formats that may be customized to meet your organizational or project needs.

*CLICK HERE to download the SPSS dataset for the resulting publication

PDF icon Patient Groups & Clinical Trials Recommendations

CTTI Recommendations on Quality by Design

CTTI Project: Quality by Design

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.

PDF icon Quality by Design Recommendations

CTTI Recommendations on Advancing the Use of Central IRBs for Multi-center Clinical Trials

CTTI Project: Single IRB

 

Primary Users: Sponsors, institutions, and organizations that serve as a central IRB

CTTI has recommended the use of a single IRB of record for multi-center clinical trials. To facilitate adoption of this model, CTTI has developed the following tools and resources.

  • Evaluation Checklist
    The purpose of this document is to assist organizations with adoption of a central IRB (a single IRB of record for all sites) model for multi-center clinical trials.
  • Template IRB Authorization Agreement
    This template IRB Authorization Agreement (IAA) is intended to address an administrative concern about using a single central IRB for multi-center clinical trials.
  • Considerations Document
    To address blurred distinctions between responsibilities for ethics review and other institutional obligations, CTTI recommends that sites and IRBs use the CTTI-developed guide (aka Considerations Document) to support communication and contractual relationships between institutions and a central IRB.
PDF icon Central IRB Advancement Recommendations

CTTI Recommendations on Good Clinical Practice (GCP) Training For Investigators

CTTI Project: Investigator Qualification

PDF icon GCP Training Recommendations

CTTI Recommendations on IND Safety Assessment and Communication

CTTI Project: Safety Reporting

PDF icon Safety Recommendations

CTTI Recommendations on the Use of Central IRBs for Multi-center Clinical Trials

CTTI Project: Single IRB

PDF icon Central IRB Recommendations

CTTI Recommendations on Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials

CTTI Project: Quality by Design

PDF icon Monitoring Recommendations

CTTI Recommendations on Improving Reporting of Unexpected Serious Adverse Events (SAEs) to Investigational New Drug (IND) Investigators

CTTI Project: Safety Reporting

PDF icon Safety Reporting Recommendations