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Clinical Research Services

Our Resources

Funded by SickKids and the Ontario Child Health SUPPORT Unit, the aim of the Clinical Trials Unit (CTU) is to enhance child health through the conduct of high quality clinical trials. CTU staff provides expert methodological, regulatory, and operational support to PIs on the design, conduct, analysis, execution and reporting of clinical trials. All types of trials (drug, device, diagnostic, behavioral), all phases (I-III), investigator-initiated and industry-sponsored trials are eligible for support.

Clinical Trials Unit Staff: 

Andrew Willan, PhD, CTU Methodologist; andrew.willan@sickkids.ca

AR Willan portrait

Dr. Willan is an academic biostatistician and clinical trial methodologist, and is currently a Professor of Biostatistics in the Dalla Lana School of Public Health at the University of Toronto and a Professor Emeritus in the Department of Clinical Epidemiology and Biostatistics at McMaster University. His contributions to statistical methodology include publications in the areas of cost-effectiveness analysis, value of information methods, management trials, crossover trials, non-nested regression analysis and bivariate response models. Dr. Willan has been particularly instrumental in developing the field of statistical analysis of cost-effectiveness data and using value of information methods for the optimal design and analysis of clinical studies resulting in 45 peer-review articles and a book, co-authored with Professor Andy Briggs, in the Wiley Statistics in Practice series, entitled Statistical Analysis of Cost-effectiveness Data. 

Dr. Willan’s collaborative research experience has primarily been in clinical trials in obstetrics and paediatrics with numerous high profile trials published in NEJM and The Lancet. Previous positions held include the Head of Biometry of the Clinical Trials Program at the National Cancer Institute of Canada and the Head of Clinical Trials and Epidemiology for the Cancer Program at Sunnybrook Medical Centre in Toronto.


Myla Moretti, PhD, CTU Health Economist; myla.moretti@sickkids.ca

Myla Moretti headshot

Dr. Moretti is currently a research associate at SickKids.  She completed her PhD in health services research and health economics from the University of Toronto’s Institute of Health Policy, Management and Evaluation. Her research focus is in maternal-child health, performing health economic evaluations alongside clinical trials.  She also holds a master’s degree in clinical pharmacology and toxicology. 

Dr. Moretti has co-authored over 60 peer reviewed publications and 15 book chapters, with extensive clinical research expertise in maternal-fetal toxicology, pharmacology and obstetric medicine. She was previously the Assistant Director of the Hospital for Sick Children’s Motherisk Program and was president of the Organization of Teratology Information Specialists.
 

Shauna Kirk, MSc, Research Quality and Risk Management (RQRM) Specialist; shauna.kirk@sickkids.ca

Shauna Kirk headshot

Shauna Kirk has a Master of Science in pathology and has more than 15 years' experience in research. She has extensive experience in bioequivalence, bioavailability and phase I to III clinical trials with expertise in study start up, study management and regulatory affairs. For over 5 years, Shauna has provided SickKids research community with advice and oversight of clinical trials and patient-based research, including regulatory support, auditing, education and training and consultation services. 

As the Research Quality Assurance Specialist, Shauna will provide support and expertise to ensure your trial meets all regulatory requirements and Good Clinical Practice Guidelines.

 

Donna Wilkes, MSc, CTU Study Logistics Specialist and CTU Coordinator; donna.wilkes@sickkids.ca

Donna Wilkes headshot

Donna Wilkes has a Master of Science in exercise physiology and has more than 20 years’ experience in clinical research.  She has worked at SickKids in various research roles including coordinator in neonatology and respiratory medicine and internationally as a manager developing research capacity for a children’s hospital in Doha, Qatar.  

She can provide consultative support with tools, templates, SOPs and other documents to ensure your trial runs smoothly and efficiently.


 

 

What is Clinical Research Services (CRS)?

Clinical Research Services (CRS) supports investigators, staff and trainees who conduct clinical research, and provides advice, support, materials and resources for all types of clinical research studies. CRS strives to support SickKids clinicians and scientists in conducting high-quality clinical research.

For more information see Clinical Research Services.

Do you want to consult with the CTU?  

Download the CTU intake form

Contact us:

Please email us at sk.ctu@sickkids.ca or visit the contact us page.