Training
CAN-TAP-TALENT focuses on expanding the capacity and efficiency of Canada's clinical trials training pipeline, in addition to developing a diverse set of skills. A national platform will structure and streamline training while also providing cross-training and job shadowing opportunities across provinces and disease networks, ensuring a steady supply of new HQP and more evenly distributing the training and mentoring load. Through the pan-Canadian Consortium, it also provides direct access to multicenter trials and Canada's internationally recognized trial experts.
Patient Engagement
To enhance patient engagement and enable more equitable patient recruitment, including from communities traditionally under-represented in clinical trials and clinical research, Dr. Clara JuandoPrats will help develop a patient engagement and patient-oriented research module, based on four pillars
EDIA, SGBA+, Social Detriments of Health
Equity, diversity, inclusiveness, and accessibility (EDIA) will be a major element of CAN-TAP-TALENT, and it will adhere to the Tri-Agency Dimensions of Care and Government of Canada Best Practises in Equity, Diversity, and inclusiveness (EDI) study. Equity entails not only providing additional opportunities or health-care resources to level the playing field, but also keeping in mind that the historical structures and policies of our academic institutions play a significant role in "preserving or dismantling the systematic inequities that pervade our societies."
Advanced Trial Design
Modern trials are increasingly employing designs that differ from classic randomized trials, which focus on one clinical topic at a time. Innovative trial designs, such as multi-arm adaptive platform trials, basket trials, umbrella trials, and cohort trials, have the potential to increase trial efficiency and incorporate biomarkers, such as genetic or radiomics indicators, to guide therapies. Decentralizing data collecting and community-based comparative advantage trials that address the generalizability of the outcomes are two more major challenges in trial design.
Machine Learning and Artificial Intelligence
Modern trials are increasingly employing designs that differ from classic randomized trials, which focus on one clinical topic at a time. Innovative trial designs, such as multi-arm adaptive platform trials, basket trials, umbrella trials, and cohort trials, have the potential to increase trial efficiency and incorporate biomarkers, such as genetic or radiomics indicators, to guide therapies. Decentralizing data collecting and community-based comparative advantage trials that address the generalizability of the outcomes are two more major challenges in trial design.
Ethics, Consent, and Protocols
Developing and writing study protocols is a specialized skill in its own right and an important one for clinical trialists: institutional research ethics boards (REBs) can take weeks or months to review a submission, and while they may provide feedback to help a team progress toward approval, each iteration adds delays. Effective protocol development and writing can help reduce delays in initiating trials. Training can help HQP understand how to identify controls, risks and mitigations to maintain participant rights, safety and well-being, and clearly articulate those steps for both the REB and the team members who will be implementing the trial. Improving knowledge in this area can not only improve clinical trial capacity, it will also enhance participant safety, data quality, and public trust in research.
Knowledge Translation (KT)
To maximize the impact of improving Canadians' health, we will teach and mentor HQP on conducting integrated KT in clinical trials and developing rapid knowledge-to-action plans for end-of-grant KT to reduce the time it takes to convert new knowledge from trials into practice.
Engaging in Translational Research
Primer Courses:
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Genomics, proteomics, metabolomics, and transcriptomics, are all based on the analysis of tissue or liquid samples to identify biomarkers, which may then guide treatment decisions (e.g. for a linked therapeutic) or stratify participants in a clinical trial.
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Novel imaging technologies that can direct trials, such as quantitative imaging, radiomics, novel imaging agents, theranostic agents, and imaging quality concepts for trial best practices, such as multi-site calibration.
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Cell-based therapies, such as identifying source cells for autologous procedures, cell handling, and GMP considerations for trials.
Trial Management
Understanding how to negotiate institutional agreements and different ethics review boards while also harmonizing trial methods. Learning how to collect and use data in research databases, accessing electronic medical records at various example institutions, and identifying, recording, and reporting adverse events and serious adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) dictionary are all part of this.
Statistical Design and Analysis
Biostatisticians will assist in mentoring recent statistics graduates and young faculty investigators in order for them to understand the specific applications of biostatistics as well as the career opportunities available. Throughout the mentorship process, the art and science of biostatistical consultation, as well as the importance of understanding the science of the trial, will be emphasized, as clear two-way communication is the key to successful and efficient biostatistical collaboration.
Grant Writing and Scientific Communication
Our team has extensive proposal preparation experience and can help develop a more specialized and applied set of grant-writing training sessions for the clinical trial audience. Scientific communication skills will be honed, with an emphasis on working as part of an interprofessional team to better prepare study comments, infographics, op-eds, and science briefs for patients, families, and policymakers.
ECHO Ontario
We will collaborate with ECHO Ontario to develop and curate virtual training tailored to clinical trial requirements. Project ECHO brings together expert interdisciplinary teams and primary care clinicians from across the country. These clinicians join a learning community where expert interdisciplinary teams mentor and provide feedback.
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Learn more about ECHO Ontario.