Quality Improvement.
National Baselines and International Standards
The quality improvement and performance metrics initiative is key to understanding the underlying sources of inefficiencies in the clinical trials process that should be addressed. Once this is established, improvements to these areas have the potential to increase the timeliness, feasibility, and number of high-quality investigator-initiated and Industry-sponsored clinical trials in Canada. Five indicators of quality and performance were identified by the Clinical Trials Consortium. MICYRN is working with its member sites to collect baseline data and plan subsequent actions to address the key identifiers.
MICYRN is also on several international working groups surveying processes across countries with an eye to ultimately improve capabilities for global trials.
Number of Investigators Participating in Child Health Research
MICYRN is developing a clinical trial checklist and procedural working documents to assist with efficiently setting up and running multi-centre clinical trials. Development of a network agreement roadmap to facilitate the legal and study teams with the clinical trial agreement and contracts is in progress. A page of resources, tools and templates for placebo development and labelling of study drug, master agreements for contracts, site training, data collection and management can be accessed HERE.
Number of Interventional Clinical Trials in Child Health Research
In order to assess the current Canadian landscape of both investigator-initiated and industry-sponsored child health clinical trials conducted over a six-year period, MICYRN undertook an analysis of 2124 trials registered on clinicaltrials.gov to develop a baseline for trials. A full report of the six-year period was produced. Results from 2020 were pulled and showed that the proportion of investigator-initiated versus industry trials stayed relatively the same—62% and 38% respectively. As expected, fewer trials were conducted in 2020 in comparison to other years, and of those conducted only five were COVID-19 trials.
MICYRN has also created a one-stop shop clinical trials access point to provide information, resources and expertise for stakeholders in industry and academic research. The internal database houses investigators and thought leaders across a variety of specialty areas across Canada to provide advice and expertise in areas such as study evaluation, protocol design, diverse stakeholder engagement and exploratory advice. For more information, please fill out our contact form.
Time from Site Initiation to First Patient Enrolled
Delays in recruiting participants into clinical trials are costly and prevent effective, therapeutic interventions from reaching children. A key recruitment metric indicator is time from site initiation to first patient enrolled. The aim of this indicator is to assess recruitment barriers, challenges, and successes.
To capture this metric, data is being in a RedCAP database, offering units two tiers of collection. The MICYRN units have been asked to collect, at a minimum, basic metrics on time from site initiation to the first patient enrolled. The database also offers a more comprehensive tier two option, which will serve as a mini clinical trial management system to collect data on regulatory, contracts, finance, study updates.
From the results of this data, MICYRN will develop recruitment documents and help reduce barriers in the clinical care setting via educational awareness videos for circle of care staff.
Percent of Targeted Patients Enrolled
Clinical trials that are unable to meet original recruitment targets or require extensions lead to trial delays and increased costs. The CHEER platform will assist in the collection of this metric for multicentre, multi-jurisdictional trials.
Action items to follow once CHEER platform is fully operationalized and metrics are collected.
Study Start-Up Time
Delays in study start-up prolong the time until safe, effective, therapeutic interventions can reach children. Two identified barriers for this quality indicator were the ethics review and contracts processes. These barriers are being addressed through the CHEER initiative’s ethics review project, the MICYRN’s Network of Lawyers for the contracts and agreements process, and the Study Start-Up and CHEER Information Repository CT navigator project.
Sign-up for the MICYRN newsletter to receive the latest updates.
