Research Projects
Long-Term Safety and Cost-Effectiveness of Biologics: Real-World Outcome Research Using Local and International Big Data

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 utilisation 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 utilisation 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.

Dr SX Li, Department of Medicine

Dr Li’s primary research interests lie in health technology assessment (HTA), health economics and real-world outcome (HEOR) research using decision analytic models and routine health data (healthcare big data). Dr Li has expertise in healthcare data analytics, cost-effectiveness assessment for healthcare interventions, and health service and policy research. Since joining HKU, Dr Li has led and contributed to many HEOR projects, all of which involves dynamic interactions with local and international academic collaborators, local government, industry partners, NGOs and other key opinion leaders.

Dr Li’s recent research focuses on biologics utilization and safety, the regional economic burden and cost-effective solutions for autoimmune diseases, and the development of outcome-based risk-sharing model for innovative and curative therapies. As a core member of CARE Programme (COVID-19 Vaccines Adverse Events Response and Evaluation Programme), Dr Li has led and contributed to several territory-wide, population-based vaccine safety assessment, particularly for patients with immunological conditions. Dr Li also acts as a Co-principal investigator of AI and Pharmaceuticals in Non-Communicable Diseases at the Laboratory of Data Discovery for Health (D²4H).

Dr Li’s research work has been supported by RGC/Early Career Scheme (PI), RGC Collaborative Research Fund (co-PI), Health and Medical Research Fund of the Food and Health Bureau of Hong Kong SAR Government (PI and co-I), HKU Seed Fund (PI), Pfizer Investigator-Initiated Research Fund (PI), Janssen Educational Research Fund (PI) and the National Natural Science Foundation of China (co-I). Dr Li has published actively in the field of HTA and health policy. She has co-authored more than 100 research articles in top-tier specialty journals in Lancet, JAMA and BMJ families."

Biography
HKU Scholars Hub
Lab
ORCID
sxueli@hku.hk

For more information or to express interest for this project, please email the supervisor or the specified contact point in the project description.  Interested candidates are advised to enclose with your email:

1. your CV,
2. a brief description of your research interest and experience, and
3. two reference letters (not required for HKUMed UG students seeking MRes[Med]/URIS projects).

Information on the research programme, funding support and admission documentations could be referenced online at the Research Postgraduate Admissions website. General admission enquiries should be directed to rpgmed@hku.hk.

HKUMed MBBS students interested in the Master of Research in Medicine (MRes[Med]) programme may visit the programme website for more information.  

HKUMed UG students interested in the Undergraduate Research Internship Scheme (URIS) may visit the scheme’s website for more information.