Companies and study sponsors around the world think carefully about where to conduct their clinical trials. They consider many factors including quality, efficiency and access to clinical trial expertise and patients. Jurisdictions around the world realise the value of clinical trials and compete to attract the investment and health care options clinical trials provide.
With support from the Government of Ontario, Clinical Trials Ontario (CTO) was launched in 2012 with the goals of improving the clinical trials environment and making Ontario more competitive in the global clinical trials marketplace. The launch of CTO underscored the importance of clinical trials in keeping and creating high-value jobs, attracting new and innovative therapies and providing Ontarians with access to innovative approaches in health care.
With Ontario already a leader in bio-sciences and one of the largest clusters in North America, investing in the clinical trials environment made sense. The strategy for CTO was developed by a diverse group of stakeholders in the clinical trials community from hospitals, universities, research ethics boards and industry – pharmaceutical, biotech and medical device companies. Input from across the community was important in identifying the critical challenges faced by sponsors and researchers as well as effective strategies to improve clinical trials and their conduct. The pillars defined in 2012 continue to guide the work of CTO – streamlining the conduct of clinical trials, engaging patients and the public with clinical trials, and promoting Ontario as a preferred location for clinical trials.
The engagement of the clinical trials community has broadened and deepened since the original strategy was penned and remains core to CTO programming. The top priority of CTO was establishing a streamlined system for ethics review. With well over 200 hospitals and about half of all clinical research sites in Canada located in Ontario, the opportunity to gain efficiencies in ethics review was evident. Over 100 volunteers from the clinical trials community – from Research Ethics Boards (REBs), institutions, research teams and industry—helped design and build CTO Stream. Launched in 2015, CTO Stream supports a single REB in Ontario in providing initial and ongoing ethics review for multiple research sites across the province.
Unique in Canada in its design and voluntary nature, CTO Stream includes a program for reviewing and qualifying REBs and a province-wide web-based ethics review system. Experts from REBs across the province participate in the REB Qualification program and serve on the REB Council which supports quality improvements and harmonization across the system. The engagement of the clinical trials community has been impressive, with 94 participating institutions across the province and 17 qualified REBs. Well over 600 clinical studies are part of the system with an average anywhere from 2 to 18 sites taking advantage of a single ethics review.
By leveraging a single REB review the time and effort to achieve high-quality ethics review across multiple research sites are substantially reduced. The province wide approval of a clinical trial is completed on average in 78 calendar days. New sites are approved to join these studies on average in less than 2 weeks, with 90 per cent of sites being approved in a month or far less. The potential time and cost savings of the streamlined REB system has been recognized by industry – 62 different industry sponsors have studies in the system. CTO Stream has recently expanded to include customized forms to accept multi-site observational research (e.g. epidemiologic studies or chart reviews) and the use of the system will continue to grow.
The success of CTO Stream exemplifies two key attributes of the clinical trials community in Ontario – a commitment to quality and a spirit of collaboration. These attributes are important as CTO works with the community to shorten clinical trial start-up times. Ontario sites will become more globally competitive as start up times shorten. Additionally, as activities that are repetitive or add little to no value are reduced both public and industry resources will be used more efficiently. The study “start-up clock” starts when a study protocol arrives at a site and ends when the first participant can be recruited. With a mechanism to streamline research ethics review already in place, CTO’s focus is now on cutting the overall time to study start-up. CTO is working with the community to design and implement a ‘Quick Start Program’. This program will employ a variety of supports and tools to ensure efficient study activation, focussing on the negotiation and finalization of clinical trial budgets and agreements.
Shortening study start-up times and developing a ‘Quick Start Program’ were the focus of a CTO workshop held on March 26th in Toronto titled “No Site Left Behind”. The content of the workshop was partly based on learnings from an industry survey of the challenges sponsors faced in Ontario. The workshop included 130 people from industry, clinical trials sites, and institutions. It was emphasized that although Canada is considered a high-quality and reliable location for clinical trials, other countries have more patient potential. To maximize participation in global clinical trials research, sites must be activated as quickly and efficiently as possible. Workshop participants brainstormed solutions to address challenges in activating trial sites quickly. Ideas ranged from specific strategies and resources, to improving communication, transparency and collaboration between industry and sites.
The 2018 CTO Conference followed the workshop on March 27-28, 2018 and underscored how the clinical trials environment is evolving at an accelerated pace. Themes resonating from the conference reflected some of the key opportunities and challenges for Ontario and Canada in the coming years. Evolving technologies—genomics, AI, big data capabilities—will impact how clinical trials are conducted and how evidence to support health care decisions is generated. Clinical trials were identified as an essential component of our health care system and patient engagement was recognized as an increasingly important component at all stages of the clinical trials process.
A priority strategic pillar for CTO is engaging patients and the public with clinical trials. CTO has convened a Patient and Public Advisory Group and works with health charities and patient advocacy groups across the province. Over the next year in partnership with these groups, CTO will focus on building resources to help patients and the public be more informed about clinical trials. CTO will also invest in resources to improve clinical trials through patient engagement and help people find and access clinical trials.
Ontario’s potential to be a leader in clinical trials within Canada and internationally is deeply rooted in the clinical trial capabilities and research and health care resources across the province. These assets are surrounded by a thriving life sciences community and health innovation sector. CTO will be working more intensely over the next year to fully understand clinical trial capabilities across the province and partner with organizations within and outside Ontario to attract more clinical trials to Canada and Ontario. To assist new international clinical trial partners, CTO has developed the Industry Concierge Program to help connect companies and study sponsors to researchers, trial sites and resources to advance their clinical trials.
The commitment to quality and the spirit of collaboration is evident everywhere in and around the clinical trials environment in Ontario. Patients and health charities, researchers and clinicians, industry and government, hospitals and universities, and our life science and health innovation sectors—all are focused on improving the quality of clinical trials, treatment options for patients and the economic and social well-being of Ontarians.
Susan Marlin is the president and CEO of Clinical Trials Ontario (CTO).