Increasing clinical trial expertise at the RI-MUHC

The RI-MUHC ACT-CTU reports on the realization of its vision for 2024 to build a clinical trials community and strengthen trial capabilities at the RI-MUHC

The RI-MUHC is a proud member of the Accelerating Clinical Trials (ACT) Canada Consortium (www.act-aec.ca), a broad initiative funded by the Canadian Institutes of Health Research (CIHR) in January 2023 to boost the impact of clinical trials in Canada.

As a leader in this national initiative, the RI-MUHC has established the Accelerating Clinical Trials – Clinical Trial Unit (ACT-CTU), which is pleased to report on the work accomplished in recent months and to announce the three winners of its inaugural internal call for flagship feasibility trial proposals. 

The winners are:

• Dr. Deborah Assayag (Translational Research in Respiratory Diseases Program; RESP) for her study entitled “First-line rituximab in patients with systemic autoimmune rheumatic disease related interstitial lung disease, a pilot study”.
  
  
• Dr. Yen-I Chen (Cancer Research Program) for his study “Prophylactic Endosonography-Guided Gastroenterostomy in Advanced Periampullary Cancers: A Pilot Multicenter Randomized Controlled Trial (INTERCEPT)”.
  
  
• Dr. Nicole Ezer (RESP) for her study “Improving post operative lung resection outcomes with eosinophil guided inhaled corticosteroids”. 

“We anticipate that these three studies will serve as pilot trials for how to best streamline RI-MUHC resources in support of new trials and build capacity for trials at our institute,” says ACT-CTU co-chair Dr. Louise Pilote. Dr. Pilote is a scientist in the Cardiovascular Health Across the Lifespan Program at the RI-MUHC, and a general internist and professor in the Department of Medicine at McGill University.

“This internal call for pilot trials is part of the realization of the ACT-CTU vision for 2024 to build a clinical trial community and increase trial expertise at the RI-MUHC,” adds Dr. Sushmita Pamidi, ACT-CTU co-chair with Dr. Pilote, and a respirologist, scientist and co-Leader of the RESP Program at the RI-MUHC. “We have been hard at work driving initiatives in keeping with its vision, including ACT-CTU Clinical Trial Rounds, Protocol Review Sessions, support with submissions to Health Canada, and more. Our RI-MUHC ACT-CTU Manager, Amanda Lovato, has been instrumental in running these programs and is an essential part of our team.”

ACT-CTU Clinical Trial Rounds

The team has organized a monthly lecture series entitled RI-MUHC ACT-CTU Clinical Trial Rounds. Expert presenters from across Canada and within the RI-MUHC address topics in clinical trials including innovative design methods, complex trials and tips for pilot study design. The intention of these Rounds has been to increase knowledge of trial conduct amongst our trialists. With 40-80 attendees per session, the team is well on its way to build the community it envisioned. 

Protocol Review Sessions 

To complement Clinical Trial Rounds, the ACT-CTU has also initiated Protocol Review Sessions, live forums where clinical trialists can receive real-time feedback on their proposed trials. This platform gathers experts and draws from the experience of others to avoid potential pitfalls that could negatively impact the success of a clinical trial. These sessions are also intended to strengthen applications to various granting agencies.

Access to a contracts specialist for RI-MUHC trialists 

As part of its third initiative, the ACT-CTU has engaged the services of a contracts specialist to support Health Canada submissions for clinical trials. This service, funded by the ACT-CTU, is currently available to all RI-MUHC trialists while allocated funds last. Concurrently, the unit is in the process of hiring a methodology trialist to serve as a valuable resource for RI-MUHC scientists.

Positioning the RI-MUHC as a leader in the field of clinical trials

To strengthen ties between the RI-MUHC and its national ACT partners, the ACT-CTU is holding regular meetings with colleagues across Canada to exchange ideas and explore opportunities for collaboration. Through these connections, the team aims to conduct multi-site national trials and share resources, including methodological support, contract negotiations, and ethical considerations surrounding clinical trials. Additionally, they seek to collaborate on joint cost-sharing initiatives for captive insurance, as well as electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) data management platforms, to enhance the conduct and organization of their trials.

To streamline the clinical trial process at the RI-MUHC, the ACT-CTU is consolidating database information from across the MUHC. This initiative aims to provide a comprehensive understanding of the current resource allocation for the planning, design, conduct, and monitoring of trials within the institution. Additionally, it seeks to identify the strengths and limitations related to clinical trials, enhancing overall efficiency and effectiveness.

The ACT-CTU is fostering stronger connections within the RI-MUHC clinical trial community, aspiring to collaborate with teams across Canada and position itself as a global leader in the design, planning, conduct, and monitoring of clinical trials.