This large-scale initiative, established and led by the Montreal Heart Institute (MHI) in a public-private partnership, is developing and deploying a digital platform and tools to conduct virtual or decentralized clinical trials (limited or no visits to clinical sites and/or hospitals).
Based on the highest quality standards and respecting the highest norms of confidentiality and data security (advanced encryption technology), the platform and its tools are transforming the way of conducting clinical trials.
The advancement of digital health technologies in recent years has created an enabling environment for the implementation of decentralized clinical trials. Most recently, the COVID-19 pandemic has further highlighted the need to modernize the way clinical trials are conducted.
Through innovative strategies and digital tools, the platform is promoting the recruitment, retention, engagement and follow-up of participants at performance thresholds well beyond conventional approaches. It is allowing us to test more therapies and confirm their ability to treat patients quicker.
“Aimed at transforming the clinical trial landscape in Quebec and around the world, this major initiative is contributing to making Quebec a world leader in the field while accelerating the creation of value for the Quebec life sciences ecosystem, patients and the healthcare system.” — Dr. Jean-Claude Tardif, founder of the initiative and director of the MHI Research Centre.
The Montreal Health Innovations Coordinating Center (MHICC) at MHI and Ecogène-21, a non-profit organization dedicated to providing access to innovation for unmet health needs, are the research organizations coordinating the virtual clinical trials conducted under this initiative. The MHICC and Ecogène-21 are joining forces to significantly increase the capacity to design, attract and conduct high quality, low cost clinical trials.
“The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization that has successfully conducted more than 75 clinical trials (including COLCORONA, a fully decentralized clinical trial, COLCOT and Dal-GenE) and 7 registries since its inception 21 years ago. With this new digital platform, the MHICC further distinguishes itself by its ability to conduct virtual or hybrid clinical trials (phases II to IV) by offering a full range of integrated services. The MHICC has specific expertise in precision medicine clinical studies, innovative clinical trials and other high quality studies, and repositioning of existing drugs. The MHICC has a network of research collaborators at more than 4,500 clinical sites in 35 countries.
This coordinating center can support both academic and industry-funded studies in all areas of medicine. The largest decentralized clinical trial in the world (10,000 participants) will soon be launched and coordinated by the MHICC,” notes Sophie Tanguay, Executive Director of the MHICC.
The initiative is made possible by investments from the Ministère de l’Économie et de l’Innovation of the Government of Quebec, and private partners, including several Quebec SMEs (small medium enterprises) as well as Ecogène-21 and the Montreal Heart Institute Foundation. Our private partners include health information technology and artificial intelligence companies such as Omnimed for electronic medical record management and patient portals, Kelvin Zero for research participant identity and data encryption, and Perceiv-AI for the analysis of mega-data generated in clinical trials. Biotechnology companies include DalCor Pharmaceuticals, Ingenew Pharma, and Renibus Therapeutics. Medical device and diagnostics companies include Noze (Stratuscent), Labeo Technologies, Optina Diagnostics and Inogen. An investment firm, InvHealth Capital, is also a partner.
“The high costs of conventional clinical trials limit the creation and growth of biotechnology companies in Quebec, which too often results in their premature acquisition by foreign entities before they can generate value. Reducing costs by conducting virtual clinical trials will bring competitive advantages to Quebec through the creation and growth of biotechnology and biopharmaceutical companies,” said Pierre Laurin, President and CEO of Ingenew Pharma and InvHealth Capital.
The initiative also has academic partners and collaborators. For example, the Centre of Excellence on Partnership with Patients and the Public (CEPPP) at the Centre Hospitalier de l’Université de Montréal has created an advisory group with patients and citizen partners to provide their perspectives and recommendations on the approaches developed and to assess their accessibility and acceptability. The Centre of Genomics and Policy at McGill University oversees the ethical and legal issues.
Finally, various strategies for drug delivery or sample collection devices are tested by the MHI’s Beaulieu-Saucier Pharmacogenomics Centre, as well as the development of medical drones in collaboration with the Alma Centre of Excellence on Drones.
