Data Analytics , RWE & RWD , Q&A
By Team Panalgo

How are Data Networks and International Collaboration Furthering Epidemiologic Research? A Q&A with Samy Suissa, PhD

Dr. Samy Suissa is a Co-Founder and Principal Investigator of the Canadian Network for Observational Drug Effect Studies (CNODES). He is Director of the Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research at the Jewish General Hospital and Professor, Departments of Epidemiology and Biostatistics and of Medicine, McGill University, in Montreal, Canada. Dr. Suissa also heads the McGill Pharmacoepidemiology Research Unit. He was the founding Director of the Quebec Research Network on Medication Use. Dr. Suissa also sits on Panalgo’s Strategic Advisory Board.

Dr. Suissa discusses the importance of data networks, growing global collaboration, and the fine balance between rapid-response research and good science during the Covid-19 pandemic.

Q: Dr. Suissa, you have led the Canadian Network for Observational Drug Effect Studies (CNODES) since its inception in 2011. Can you tell us about its genesis?

A: Canada has had a national healthcare insurance program since the 1970’s. While the Federal government funds the program, it is administered independently by each province and, as such, each province has been managing its own healthcare databases since then. One of the first provinces to allow use of its databases for research purposes was Saskatchewan. Since it had complete medication data on the entire population, it became an attractive tool for the early pharmacoepidemiology studies using computerized databases in Canada.

Over the years, data from other provinces became available and research initiatives were put in place around Canada, particularly in Quebec, Ontario, British Columbia, and Manitoba. As scientists, we understood the importance of studying drug safety on a national basis and were thrilled when Health Canada, the Drug Safety and Effectiveness Network (DSEN) and the Canadian Institutes of Health Research (CIHR) put out a request for proposal to create a countrywide network to study questions of drug safety and effectiveness in Canada.

Dr David Henry and I led this initiative, that we named CNODES, for which we were funded in 2011. The team included superstars in pharmacoepidemiology from across Canada, with facilitated access to all healthcare databases. The idea behind forming the network was to pool knowledge and data to answer questions that are pertinent to Health Canada and other stakeholders, with the particular purpose to protect the health of all Canadians.

Q: How does CNODES allow you to perform better research?

A: The greatest asset of CNODES is its pooling of brain power and human resources to identify and conduct the most rigorous research. Every study includes experts in pharmacoepidemiology, study methods, biostatistics, medicine, clinical pharmacology and pharmacy, as well as expert data analysts. There is the added challenge that the provincial data must remain within each province. So, we must combine the results of each provincial analysis to generate an overall pooled estimate of effect. This, however, has the added benefit of providing replication, a crucial element of the scientific method.

Q: What were some of the lessons learned from creating this data network?

A: The most important lesson is that a data network requires many more components than just data. We created several special teams around study methods, data, training and knowledge translation. Access to data is certainly key, however. Fortunately, we’ve had tremendous support and assistance from the Canadian provinces in that regard. The provincial guardians of the data came on board quickly to provide us with rapid access to data for studies done under the CNODES banner.

Teamwork is also critical to leverage the expertise of epidemiologists, statisticians, pharmacologists, pharmacists, and clinicians who have worked with databases. Having this type of group has allowed us to conduct important studies.

Q: Can you provide some examples of the studies you’ve done leveraging CNODES? 

A: We’ve conducted a number of important studies that have had an impact on public health and regulatory decisions.

For example, we conducted a utilization study on the use of isotretinoin, a teratogen widely used to treat cystic acne, proscribed for pregnant women. We found that adherence to the isotretinoin pregnancy prevention program in Canada was poor during 1996-2011, the 15-year period of this study. Another study examined the use of dipeptidyl peptidase 4 (DDP-4) inhibitors to treat type 2 diabetes that was thought to cause an increased risk of heart failure. Our multi-province study of over 1.5 million patients with type 2 diabetes found that there was no such increased risk.

Another study of over 130,000 new users of statins showed that higher doses of statins were associated with an increased risk of diabetes, a finding that supported Health Canada’s warnings about their use. We also conducted a study to test the prevailing theory that proton pump inhibitors (PPIs) used to treat acid reflux and ulcers could increase risk of pneumonia. We worked with gastrointestinal specialists and pharmacologists to develop a unique study design that found no such increased risk.

These and other pan-Canadian studies of the safety and effectiveness of drugs can have a real impact on the health of a significant portion of the Canadian population.

Q: How has COVID-19 highlighted the need for global epidemiology?

A: The study of COVID-19 is perhaps the best example of the growing international collaboration of epidemiologists, since this virus knows no borders. Studying COVID-19 will be a living example of the importance of global collaboration going forward. We can anticipate, and some discussions have already started, that all regulatory agencies and research networks will work together on different initiatives involving treatment and vaccines for COVID-19.

Even before COVID-19 we had already initiated collaborative studies between Health Canada and the European Medicines Agency (EMA), such as the one on newer direct oral anticoagulants (DOACs) and the one between Health Canada and the FDA on the 2018 recall of angiotensin II receptor blockers. Drugs for rare diseases may be another area where collaborative research will become important to answer questions that we may not be able to achieve on our own.

Q: There’s a sense of urgency right now, especially with the pandemic to publish research. How do we balance the urgency for information with good science?

A: There’s definitely a sense of urgency to understand this virus, and the desire for speed is certainly understandable. Add to that the growth of healthcare databases and the increased number of journals that will publish non-peer reviewed research means we have moved into a wild west of database research. Having access to data and rapid analysis doesn’t easily translate to valid research.

High quality research requires the input of a host of specialists in building the study protocol – clinicians, biostatisticians, epidemiologists, database experts and the like. Developing the study protocol and the statistical analysis plan as a team is what takes the longest time when conducting such studies and it is what helps assure valid results.

Good science requires reflection. We were skeptical when we saw the results of some of the early COVID-19 treatment studies that were published – and eventually retracted. Reliable studies require careful thought and rigorous peer review.

Where we have seen an improvement in speed is better data access and tools for more rapid analytics, especially those involving common data platforms. This is where we can improve study efficiency, particularly when based on well validated data sources and analytic tools.

Q: Any final thoughts?

A: We are entering an unprecedented era of widespread healthcare data access, presenting a major challenge of the fine balance between rapid research and good science. Global collaboration of data networks and, more importantly, of people networks, can help provide the valid evidence necessary to improve public health and clinical practice.




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