The CANSTAT program will build on three key strengths
Strong Collaboration Across Institutions
The program builds on the strong collaborative and educational efforts of participating institutions and is supported by a committed team of researchers with complementary expertise and extensive experience in trial design, biostatistics, trial operational management, clinical science, ethics and regulatory processes.
Unique Experiential Learning Design
The program will provide a unique blend of methodological, computational, operational and professional skills training through mentorship and experiential learning embedded in a multidisciplinary environment within clinical trials organizations across the country.
Commitment to EDI
The program is committed to EDI in our composition, recruitment and practice.
Information Box Group
The program is designed as a one-year full time fellowship comprised of three components:
A foundational component of the training program is a one-year full-time placement in an institution/ organization conducting clinical trials. Fellows will be co-mentored by a clinical trials biostatistician and a clinical investigator leading trials of their own.
Experiential Learning Placement - Learn More
This placement will give fellows hands-on experience with actual clinical trials. Fellows will undertake biostatistician duties under the supervision of their mentors.
In addition, fellows will be exposed other aspects of the clinical trial enterprise, such as ethics, non-statistical elements of study design, designing data collection forms, database design and coding, regulatory affairs issues, reporting requirements and interacting with research staff, investigators and IT/database experts. Collaboration and communication skills are key to successful integration within a clinical trials team and will be continually utilized and improved upon throughout the experiential learning component of this training program.
During the program, fellows will be exposed to several themes that are critical for biostatisticians involved in clinical trials. These include but not limited to:
- Trial design
- Creating randomization schedules
- Sample size estimation and power analysis
- Statistical analysis plans (development & execution)
- Data management and analysis
- Trial Steering Committee operations
- Data Safety Monitoring Boards (DSMB)
- Regulatory applications and processes
- Manuscript preparation
- Oral and written communication skills
For more details on mentorship guidance, please download CANSTAT – Experiential Learning and Mentorship Guidance
Fellows will complete a series workshops given by experts to gain clinical trial knowledge and increase technical skills in clinical trials. These workshops will be grounded in the design and analysis of clinical trials to allow fellows to appreciate the challenges and nuances of working in an applied space.
Online Workshops - Learn More
The objectives of the workshops are to:
- Summarize and illustrate key concepts and principles in clinical trials
- Review available resources to support experiential learning (e.g., literature, software)
- Present best practices in clinical trial design and analysis
- Identify and discuss issues where consensus doesn’t exist
- Introduce non-standard designs such as early-stage dose-finding trials, pragmatic trials and innovative platform and adaptive trials
The workshops will cover a range of topics including:
- Working with non-biostatisticians
- Ethics & Regulatory issues in trials
- Reproduceable research
- Principles of clinical trials
- EDI considerations in trials
- Confirmatory and exploratory analyses
- Endpoint/outcome selection
- Replacement endpoints
- Sample size and power
- Statistical analysis principles
- Missing data in trials
- Statistical writing and reporting
- Economic Analysis
- Analysis of safety data
- Non-inferiority designs
- Early-stage (Phase I, II) designs
- Bayesian design
- Adaptive designs
- Design and analysis of vaccine trials
- Design and analysis of cluster and stepped-wedge trials
Annual Meetings - Learn More
The goal of the first meeting is to equip fellows with the minimal set of skills required to partake in the experiential learning component of the training program.
The second capacity meeting will focus on addressing future development needs and training as future leaders in the field of clinical trials.
The annual meetings will be designed to maximize the interaction between fellows and researchers and provide opportunities for networking and developing collaborations for all participants.
We have taken several steps to achieve this:
- Seeking diversity in our investigators and fellows
- Appointment of an EDI-champion to support and monitor EDI activities.
- Ensuring that training materials are developed to accommodate diverse learners.
- Standardizing the training, mentorship and experiential learning to ensure that fellows have equitable opportunities to thrive in the program.
- Transparency in the CANSTAT policies regarding selection, training, travel, authorship, grievances and expectations using inclusive language.
- Tracking EDI data over time to monitor any inherent biases in the program.
- Incorporating EDI principles in training modules.
- Appointment of an ombudsperson to address grievances and complaints.
- Continuously identifying and implementing best practices to enhance equity.
CANSTAT is one of the Canadian Trials Training Platforms funded by the Canadian Institutes of Canadian Research.
The program is designed as a one-year full-time fellowship beginning in Sept 2023 and ending in August 2024.
Applicants must have completed their graduate program before the start of the CANSTAT program (September 2023) to be eligible.
No, you cannot defer enrolment if accepted into this program. You will need to apply again if you are not able to accept placement into the program.
No, fellows must commit to full-time enrolment in the program.
Fellows will receive a total of $70,000 in salary and benefits for the year to be distributed in accordance with the mentor’s institutional policies. In addition, fellows will receive travel stipends to attend two annual meetings as well as a conference of the fellow and mentors’ choosing.
The experiential learning working environment will be dependent on the mentors and their respective institution’s policies.
Travel to the annual meetings is encouraged and CANSTAT will provide fellows with travel stipends. Other travel will be agreed upon with mentors.
Yes, fellows who complete the program will receive a certificate at the annual meeting.