Clinical Trial Navigators.

Building Research and Education Capabilities

The clinical trial navigators play a critical role in ensuring MICYRN is able to build child and family-centric research and education capabilities. They provide support to the Clinical Trials Consortium to streamline clinical trial processes and systems, thus enhancing the quality and efficiency of regulated and non-regulated trials.

MICYRN’s Clinical Trial Navigators

Ashton Chugh (ACHRI)
Kelly Sandhu (BCCHR)
Wenli Xie (McMaster University)

 

Quality Improvement and Performance Metrics


Delays in study start up and participant recruitment into clinical trials prolong the time until safe, effective, therapeutic interventions can reach children. The CT navigator assists individual research units in their data collection and metrics reporting for the following indicators: site initiation to first participant enrolled; study start-up time (ethics and contracts); percent of targeted participants enrolled; number of child health investigators participating in clinical trials; and number of child health clinical trials.

Integration of Research and Clinical Care in Pediatric Academic Health Care Centres


A major issue faced by pediatric academic health care centres is a lack of integration and awareness of research at the bedside and in clinical care activities. Input from the clinical research coordinators at child-health research institutes across Canada was sought to understand the types of topics that would be impactful, relevant and of interest for clinical staff. This included advocacy, and awareness that patients have a desire to be informed of and provided with clinical trial opportunities, with the autonomy to choose whether or not they participate. Practical ways of supporting the continuation of clinical trials while managing care, including coordinating research assessments with clinical assessments was also identified. Challenges with navigating the "circle of care" to ask for permission to approach the patient and family for consenting to participate in research studies was also identified. And finally, current processes to ensure safety and proper reporting of adverse events when a patient is enrolled in a clinical trial was identified as critical topic.

A CT navigator is completing a literature search to gather information on existing resources for the integration of research into clinical care settings. In addition, short educational and awareness materials are being created to support the integration of research into clinical care in a readily accessible media format for managers, front-line staff, patients and families.

Study Start Up and CHEER Information Repository


Information is not always easily accessible, and at times is non-existent for details of requirements and processes needed to conduct a clinical trial at a local institution. The lack of accessibility contributes to investigator reluctance to participate in trials, and creates study start up delays. A CT navigator is creating a repository and database of all of the local requirements at each institution to conduct a clinical trial. Repository documents include, but not limited to, site intake processes; local ethics requirements, including institution specific forms; the contract process; vendor start up (this includes pharmacy, lab, diagnostic imaging, and other items); and operational, institutional, and administrative approvals.