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Long-term safety and cost-effectiveness of biologics: real-world outcome research using local and international big-data


Department of Medicine

Applications accepted all year round Funded PhD Project (Students Worldwide)

About the Project

Autoimmune diseases are disorders caused by dysregulation of various aspects of normal immunity and inflammation. The introduction of biologics has significantly improved the control and prognosis of autoimmune diseases. There is a tendency that biologics and biosimilars will become the first-line treatment of autoimmune diseases, given the booming evidence from trial and real-world settings. All of these agents target cytokines or cells, which are also key components of normal immune homeostasis. Therefore, blocking particular cytokines or cells might result in adverse events, particularly increased the risk of severe and opportunistic infection, and this aroused the health careers and pharmacy advisors’ attention. It’s essential to regulate the efficacy and safety of biological treatments.

Open-label extension and post-marketing observation in a real-world setting are vital to evaluate effectiveness, safety and uptake of biologics in real practice settings. Some observational studies showed somewhat different patterns than that of RCTs suggesting retention of initial biologic decreased during long-term treatment among patients. Patients who failed in the first biologic may benefit from the second line but inferior in the retention rate. The retention rate of biologics is influenced by the tolerance of patients to the treatment, effectiveness, adverse effects or disease remission due to the usage of biologics. Few if any studies have ever investigated the overall pattern of biological treatments or treatment trajectories, including subsequent therapy changes and dose reductions, on an individual patient level.

The project aims to draw an overall pattern to better understanding the therapy utilization and changing situations of biological treatments on an individual patient level from real-world big-data. The project will use the territory-wide electronic medical records (EMR) to evaluate the biological treatment utilization in Hong Kong and provide vital evidence for further pharmacovigilance and clinical guidance among autoimmune diseases. Beyond the local data, the research program will also include the application of global big-data (UK, Taiwan, Korea and Mainland China) and decision-analytics to landscape the effectiveness, safety, cost and cost-effectiveness of biologics under the dynamic evolving market.

Supervisor

Dr Shirley Li is currently an Assistant Professor appointed jointly by the Department of Medicine and the Department of Pharmacology and Pharmacy at The University of Hong Kong. Her primary research interests lie in real-world outcome (HEOR), health technology assessment (HTA) and health economics and research using decision-analytic models and electronic health records (healthcare big data). Since joining HKU in 2014, Dr Li has led and contributed to many HERO projects, all of which involves dynamic interactions with local and international academic collaborators, the local government, industry partners, NGOs and other key opinion leaders. Dr Li’s recent research focuses on the cost-effectiveness, prescription and trajectories of biologic and biosimilar treatments among patients with autoimmune diseases. She has published actively in the field of public health science, health service and health policy, covering the therapeutic areas of infectious diseases and vaccinology, cardiovascular diseases, diabetes mellitus, autoimmune diseases and rare diseases. Dr Li’s research work has been supported by Health and Medical Research Fund of the Food and Health Bureau of Hong Kong SAR Government (PI), HKU Seed Fund (PI), Pfizer Investigator-Initiated Research Fund (PI), Pfizer Educational Fund (PI), Janssen Educational Research Fund (PI) and the National Natural Science Foundation of China (co-I).

ORCID: https://orcid.org/0000-0003-4836-7808

Faculty information, funding opportunities and application deadlines: https://www.findaphd.com/phds/program/biomedical-research-hku-li-ka-shing-faculty-of-medicine/?i586p4119

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