Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021

Article Pharmacology & Pharmacy

Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information

Catherine Lau et al.

JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES (2022)

Article Cardiac & Cardiovascular Systems

Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies First Results From the RCT DUPLICATE Initiative

Jessica M. Franklin et al.

Summary: The study found differences between RCT and corresponding RWE study populations, but showed that selecting active comparator therapies with similar indications and use patterns can enhance the validity of RWE. Despite efforts to closely emulate RCT design, agreement between RCT and RWE findings varied depending on the agreement metric used, indicating the need for further research to understand the frequency and contexts in which RWE findings match RCTs.

CIRCULATION (2021)

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Article Economics

Use of External Comparators for Health Technology Assessment Submissions Based on Single-Arm Trials

Dony Patel et al.

Summary: The study found that the number of SAT-based HTA submissions increased 13-fold between 2011 and 2019, with around 65% focused on oncology or hem-oncology. Of the 226 submissions, approximately 52% used some form of EC data, with an overall acceptance rate of 48% and 59% when including RWD EC data. The use of RWD ECs increased over time while prior trial ECs decreased, impacting acceptance rates.

VALUE IN HEALTH (2021)

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Article Oncology