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.
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.
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.
CTTI Project: Novel Endpoints
In addition to the recommendations, a suite of tools have been developed to assist with implementation:
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.
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.
CTTI Project: Streamlining HABP/VABP TrialsCTTI Recommendations for Streamlining Protocol Elements for HABP/VABP Trials
CTTI Project: Streamlining HABP/VABP TrialsCTTI Recommendations for Optimizing Operational Efficiency For Data Collection In HABP/VABP Trials
CTTI Project: Recruitment
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.
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.
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.
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.
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.