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UBC understands the challenges surrounding registries and other real-world data studies. Our epidemiological approach to registries and other non-interventional studies focuses on collecting relevant data to understand the natural history of the diseases for which treatments are being developed, and the real-world use of medicinal products in the post-marketing period, either as an ad hoc study, in electronic medical records, or by leveraging existing databases and registries.
Increasingly, regulators, payers, providers, and patients require real-world safety, effectiveness, and other outcome data to support approval, reimbursement, and treatment decisions. We design and implement studies to meet these needs while at the same time minimizing burden to investigators and patients. Our work spans all therapeutic areas, with a particular focus on rare disease and orphan indications, and on advanced therapy medicinal products (ATMP) such as biologics, cellular immunotherapy, genetically modified T-cell therapies, and vector-based gene therapy.
The collection of data through registries plays a critical role in defining disease-modifying gene therapies and redefining the progression and treatment of natural diseases. Following the evolution of rare diseases and measuring therapies’ impact on patients, caregivers and the overall healthcare system are vital to the success of clinical trials and patient outcomes.