This project aims to use Value of Information methods to design and implement a clinical trial. This clinical trial aims to evaluate drugs to reduce anxiety for children undergoing laceration repair in the paediatric emergency department.
Access with Evidence Development schemes (AEDs) can support the timely adoption of novel therapies by allowing patient access to these therapies whilst mandating that additional data be collected. These additional data are analysed to support the revaluation of the therapy and potential reversal of the approval decision. Value of Information methods have been suggested to support the design of AEDs but have rarely been used. This project combines researchers and policymakers to improve the use of VoI in AEDs with the aim of expediting approvals in Canada for promising new drugs.
VoI measures can be complex to calculate, especially in early phase and adaptive trials. This project aims to address these issues through the development of novel VoI methodology focusing on characterizing uncertainty and calculating VoI in adaptive trials.
The ATTACC and ACTIV-4 trials evaluated the efficacy of therapeutic-dose parenteral heparin versus usual care in hospitalized COVID-19 using a Bayesian response adaptive design. The IMPaCT team are working to analyze these data and understand more about the efficacy and safety of therapeutic-dose parenteral heparin.
The PRACTICAL Randomised Controlled Trial is a platform trial that enables phase II and III evaluation of a range of potential interventions and strategies to improve outcomes for patients with acute hypoxemic respiratory failure (AHRF). AHRF is a common, life-threatening condition that leaves patients vulnerable to lung and diaphragm injury associated with mechanical ventilation along with other nosocomial complications of critical care. The platform enrols adult patients with AHRF to evaluate various related interventional strategies.
Canadian Network for Statistical Training in Trials (CANSTAT)
The Canadian Network for Statistical Training in Trials (CANSTAT) is a pan-Canadian, multi-institutional and multidisciplinary training platform that will provide participants with the technical skills and practical experience needed to become leaders in their field and to ensure that clinical trials generate the highest-quality evidence to improve the health of Canadians.
The goals of the program are to equip fellows with:
Knowledge about clinical trials
Required technical and interpersonal skills
Opportunities to implement skills into practice
The CANSTAT program will bring fellows together with clinical and statistical experts in clinical trials and allow fellows to learn through a comprehensive experiential learning program. Formal education will also be provided through workshops led by clinical trial experts from around the world, and though in-person capacity-building meetings.
Upon completion of the program, fellows will be prepared to work as professionals in biostatistics as effective collaborators, communicators, scholars and leaders who will contribute significantly to academic and industry clinical trials in Canada.
Statistical Design of Bayesian Adaptive Clinical Trials
This project will develop novel statistical methodology to improve the design of platform trials that minimize patient burden by efficiently answering multiple research questions, and dose-finding studies, to ensure safe and effective treatments are evaluated in later trials. We will also develop methodology to address the computational barriers to Bayesian adaptive trial design from two perspectives.
CANSSI is Canada’s catalyst for discovery and innovation in statistical sciences and for advances in collaborative research and training. CANSSI programs support the pursuit of cutting-edge collaborative research involving statistical sciences along with the communication and application of the results to science, engineering, and society.
CANSSI is supported under the Discovery Institutes Support program of the Natural Sciences and Engineering Research Council of Canada.
The IMPaCT team is dedicated to creating a collaborative academic environment of excellence in which we all feel valued, supported and encouraged to grow. We strongly believe that equity, diversity and inclusion are fundamental to this vision and aspire to cherish all irrespective of race, indigenous status, gender, sexual orientation, age, career stage and health status.