What would a symphony be without a conductor, or a recipe without a chef? These experts are essential to the success of an orchestra or a delicious dish and without them, the final product could falter. 

Clinical trials are no different. While clinicians bring forward research questions and guide clinical implementation, biostatisticians work closely with them to design trials that are rigorous and reliable.  

Like architects, biostatisticians help ensure the structure of a study is sound – but it’s a collaborative blueprint, built with shared expertise. Without this partnership, health research, and ultimately patient outcomes, could suffer. 

“Biostatisticians are core to a clinical trial, and unfortunately there’s a critical shortage in the workforce,” says Sameer Parpia, an associate professor in the Departments of Oncology and Health Research Methods, Evidence, & Impact at McMaster University. “It’s a significant barrier to the advancement of the clinical trial industry internationally.” 

Enter the Canadian Network for Statistical Training in Trials (CANSTAT): a multi-institutional national program hosted at McMaster that trains junior statisticians in clinical trials. 

Over ten years ago, Parpia, who is the director of CANSTAT, completed his PhD in biostatistics at McMaster. Under the mentorship of his supervisors, he finished the program with a range of experience and felt prepared to apply his theoretical knowledge. But he soon realized, this wasn’t the case for all junior statisticians.  

“While graduate and doctoral learners graduate with a strong understanding of statistics theory, they often have limited exposure in applying that theory to clinical trial design, conduct, monitoring, and analysis,” he says. This limited exposure worsens the consequences of the biostatistician shortage – few people can do less. 

Through a one-year full-time fellowship, CANSTAT bridges that gap for junior statisticians, training them through mentorship and experiential learning.  

In 2023, the Canadian Institutes of Health Research (CIHR) announced $2.5 million for CANSTAT, which provides successful applicants with master’s or doctoral degrees in statistics, biostatistics, or a relevant health sciences discipline with funding to pursue the yearlong learning opportunity.  

Since then, two cohorts of successful applicants have been immersed at an institution conducting clinical trials and have been co-mentored by a clinical trials biostatistician and a clinical investigator leading trials of their own. 

In addition to the experiential learning placement, fellows complete a series of workshops to gain clinical trial knowledge and increase their technical skills. The workshops are grounded in the design and analysis of clinical trials to allow fellows to appreciate the challenges and nuances of working in an applied space. 

“The best trials are the ones where there is a good partnership between the clinical researcher and the biostatistician, because a biostatistician is an expert in study design, data collection, statistical analysis and interpretation making sure the study is methodologically rigorous and capable of producing reliable results,” says Parpia. 

Fellows also attend two annual meetings, which equip them with skills to participate in the experiential learning component of the training program. The annual meetings maximize the interaction between fellows and researchers and provide opportunities for networking and developing collaborations for all participants. 

There are many strengths to the CANSTAT program, including its pan-Canadian collaboration – eight institutions across the country offered placements to fellows in the latest admissions round. But for Parpia, it’s the experiential learning and networking opportunities that make the program one-of-a-kind.  

“Fellows work on real clinical trials for that year. Mentors and trainees develop a learning plan to outline how they’re going to meet their competencies. And to me, that’s invaluable. They’re not learning from data in a repository – these are actual, ongoing trials that impact patient lives – and we are able to offer that because we have the necessary agreements in place,” he says. 

The proof of CANSTAT is in the pudding. Graduates of the fellowship have gone on to full-time statistician roles with hospitals, and to date have contributed to over 110 clinical trials across Canada. The success of the program is captured in a recent publication which summarizes the past three years and provides a guide for other institutions to establishing a similar program. 

“If 70 per cent of our fellows either take a job in clinical trials or further their education in clinical trials, we would consider that a success,” he says. “Biostatisticians play a very important role in the design and analysis of a study, and in generating evidence-based medicine.”