Project 466173

Clinical trials are human scientific experiments designed to answer specific questions about biomedical and behavioural interventions. The quality of a clinical trial (CT) depends, among other aspects, on rigorous design and analysis of the trial. A biostatistician defined as an expert in "statistical processes and methods applied to the collection, analysis, and interpretation of data relating to human biology, health, and medicine" plays a key role in the design and analysis of trials. There is a critical shortage of CT biostatisticians in Canada, and the need to build capacity in this area is recognized by the health research community. Graduate biostatistics programs focus on theoretical foundations; however, they lack specific practical and applied training in CTs. Training and mentoring the next generation of CT biostatisticians is vital to the to ensuring that trials generate the highest quality evidence to improve health for Canadians. To increase capacity, we propose to create and implement an innovative fellowship program to train and mentor biostatisticians in CTs through experiential learning, workshops and capacity building meetings. The program will place trainees in CT groups and networks across the country to be trained and mentored by biostatisticians and trialists currently involved in the conduct of CTs. It is crucial that the trainees are imbedded into these groups to acquire hands on experience of the day-to-day operations of CTs. In addition, trainees will be required to attend workshops throughout the year covering important topics related to the design, conduct and analysis of trials. Lastly, trainees will also be required to present their work at capacity building meetings. The program will provide the technical and soft skills as well as practical experience for trainee biostatisticians with the aim of producing expert professionals who are collaborators, communicators, scholars, and leaders in the field of CT biostatistics.