Breaking New Ground

Life Sciences - The pace of medical discovery is accelerating, increasing the pressure on life sciences researchers to complete clinical trials quickly, efficiently and with the high quality data that regulators demand. In Ontario, life sciences leaders continue to break new ground every day. They are finding the solutions needed to answer some of the world's most elusive medical questions. The Canadian province's vibrant life sciences sector, through clinical trials, is helping healthcare leaders bring life-saving solutions to global markets. These solutions provide positive patient outcomes, affordable medicines, shorter hospital stays and high quality jobs. Ontario has long been a destination of choice for major international clinical trials sponsored by multi-national pharmaceutical companies, publicly funded research institutions and universities, and small/medium life science and medical device companies.

Ontario conducts Phase I-IV clinical trials in research areas such as cancer (all types), urinary tract, sexual organs and pregnancy conditions, general pathology, digestive system diseases, nervous system diseases, immune system diseases, and heart and blood diseases and mental health.
Our trials put patient safety first and address every aspect of patient care. We deliver treatment trials (that test new treatments or drugs), diagnostic trials (that test better ways to detect disease), prevention trials (that explore new ways to prevent disease), and quality of life trials (that improve quality of life for individuals with chronic disease).

As a result, the province has become a magnet for clinical research. Our record of accomplishments goes back a century and includes advancements in virtually every area of healthcare. The life-saving solutions developed in Ontario are tested for global markets using our recognized clinical trials expertise and resources.

Life Sciences Commercialization Strategy
In 2010, Ontario launched a $161 million (figures given are Canadian dollars) Life Sciences Commercialization Strategy. The main goals of this Strategy are first to build on Ontario's capacity for achieving world firsts in health-related research. And second to create new opportunities for partnerships with international companies and other innovative jurisdictions.

The strategy includes a commitment of $17 million to establish a province-wide coordinating framework for clinical trials that will streamline ethics reviews and administrative processes for our province's multi-center clinical trials. Ontario continues to invest significantly in modernizing its clinical trials framework. The result: increased patient recruitment, reduced trial start-up times and a stronger value proposition for investors.

Quick Facts
More than 5,200 clinical trials are underway in Ontario at any given time. From 2004-2008, the number of oncology trials in Ontario ranged from 450-550, involving between 5,000-6,000 patients. In 2009 alone, pharmaceutical companies spent $280 million on clinical trials in the province.
Why Innovate in Ontario?

For close to a century, our researchers have been at the forefront of major breakthroughs in nearly every area of medicine. Ontario is where insulin was discovered. It's where the pacemaker was developed. It's where the first successful lung transplant was performed. A system for automatic and inexpensive DNA sequencing was developed here. Ontario is where L-DOPA for the treatment of Parkinson's disease originated and where a synthetic bone substitute was created. It's no accident that so many life-changing discoveries have taken place here. In Ontario, life science and pharmaceutical firms can take advantage of a globally competitive testing environment, world-class clinical research talent, access to public healthcare system and diverse patient populations, competitive costs and R&D tax incentives, and government support for clinical trials.

A globally competitive testing environment
Major international medical authorities recognize the validity of data from Ontario clinical trials. We have well-established clinical trials networks and contract research organizations highly experienced in managing clinical trials across Canada and around the world. Staff are trained in Good Clinical Practices (GCP) and our workforce is one of the best educated in the world. In fact, 61% of Ontario's workforce has completed post-secondary education, the highest percentage among G7 nations.

World-class clinical research talent
Ontario's researchers are recognized for their expertise in designing and managing complex clinical trials. Our legacy of biomedical discovery inspires and attracts the world's best researchers. It is grounded in Ontario's unique collaborative research environment.

Access to public healthcare system and diverse patient populations
Ontario offers resources that help healthcare leaders accelerate their clinical trials. The province has a centrally managed public healthcare system. This makes it easy to access a population of more than 13 million that is demographically and ethnically diverse, a critical advantage that can accelerate understanding of the trial drug's impact on different population subgroups. This enables more efficient drug development and helps ensure safe and effective medical products for a broader range of users.

Highly competitive costs and generous R&D tax incentives
Clinical trials costs here are 8% below costs in San Diego and 11% below Boston, for example. Also, the province has established a number of funding programs. Ontario's R&D tax credits are considered to be among the most generous in the industrialized world.

Strong government support for clinical trials
We are constantly working to improve both funding support and service delivery. Our 2010 Life Sciences Commercialization Strategy committed an additional $17 million for clinical trials-related initiatives. Just as important, Ontario offers a highly efficient regulatory ethics review process overseen by Health Canada. It takes just 30 days to review Phase I to Phase III protocols, and seven days to review Phase I bioequivalence trials. In the future, a new province-wide coordinating framework will streamline ethics reviews and administrative procedures for all multi-center clinical trials conducted in Ontario. This streamlined framework is built on the success of the Ontario Cancer Research Ethics Board (OCREB), founded in 2003. OCREB coordinates the research ethics review process for multi-center cancer trials using a unique centralized ethics review model. This approach reduces duplication, shortens study start-up time and provides the highest quality of review.

Ground-Breaking Innovations in Clinical Trials
In 1986, a landmark study called the North America Symptomatic Carotid Endarterectomy Trial (NASCET) was led by Dr. Henry Barnett, scientific director of Robarts Research Institute. This was a multi-center, randomized, controlled trial of nearly 3,000 patients from more than 100 international sites. It defined the role of carotid endarterectomy in stroke prevention. Dr. Barnett's work with Aspirin as a preventative therapy for heart attack and stroke remains one the most important developments in 20^th-century medicine.

From 1993-1995, the international HOPE study (Heart Outcomes Prevention Evaluation) was led by McMaster University researchers. The trial evaluated the effects of ramipril and vitamin E in high-risk cardiovascular disease patients. Ramipril significantly lowered the risk of major cardiovascular outcomes by 25-30% in a broad range of high-risk middle-aged and elderly people with diabetes mellitus. Many physicians now prescribe ramipril for patients with diabetes or congestive heart failure.

The 2007 BART study 3 (Blood conservation using Antifibrinolytics in a Randomized Trial) has changed clinical trials practice around the world. It was one of the largest heart surgery trials ever conducted, involving more than 2,970 high-risk cardiac surgery patients from 19 Canadian centers. The study was centrally administered by the Ottawa Hospital Research Institute.

Ontario, thus, has proven to have the people and the resources that today's leaders in life sciences need to efficiently test their promising innovations.