COVID-19: DSRU research and capabilities
The urgent public health need for expedited development and the current reduction in the incidence of COVID-19 in many countries will result in lower availability of clinical trial data and reliance on biomarker data compared to usual vaccine development. So post-authorisation studies will be needed not only as a regulatory requirement but to fill important information gaps and address uncertainties at the time of launch.
The UK Consortium for Monitoring the Post-authorisation Safety and Effectiveness of COVID-19 Vaccines
- We launched The UK Consortium for Monitoring the Post-authorisation Safety and Effectiveness of COVID-19 Vaccines in July 2020.
- The Consortium will use real-world data to survey the near real-time safety of new COVID-19 vaccines throughout the UK.
- Members of the Consortium bring decades of experience in epidemiology, primary and secondary NHS care and pharmacy, meaning that the Consortium is very well placed to conduct the post-authorisation surveillance that is so vital for new COVID-19 vaccines.
- The work of the Consortium will build on our experience in active surveillance of vaccines: the H1N1 swine flu vaccine during the 2009 pandemic (see paper) and the seasonal flu vaccine every year since 2014 (see paper).
- Our surveillance methods benefit from the structure of the NHS and were developed to allow near real-time reporting of safety and effectiveness signals, which will be crucial for monitoring COVID-19 vaccines.
- We look forward to working with colleagues at the MHRA and a broad range of organisations such as Public Health England, the NHS, Department of Health and pharmaceutical companies.
Systematic Benefit-Risk Assessments
Dozens of clinical trials are underway around the world, many on repurposed drugs, but it is important to look at the benefit-risk balance of the proposed new treatments.
- Our team of epidemiologists and medics has conducted systematic benefit-risk assessments on a number of proposed treatments for the virus.
- Our benefit-risk assessment approach is based on the BRAT methodology
- Crucially our method is dynamic, meaning that it can be revised and updated as further data becomes available.
- Read more about our benefit-risk assessments here or read our papers below.
Remdesivir: Read our published systematic benefit-risk assessment of remdesivir
Lopinavir/ ritonavir: Read our published systematic benefit-risk assessment of lopinavir/ ritonavir
Chloroquine/ hydroxychloroquine: benefit-risk assessment awaiting publication
Post-authorisation safety studies (PASS)
- Inevitably clinical trials on potential COVID-19 treatments will be shortened, so it will be essential to monitor the safety and effectiveness of these new treatments at the post-marketing stage.
- We are ready to undertake PASS studies on COVID-19 treatments.
- We have 40 years’ experience of PASS studies conducted on real-world data in both primary and secondary care, and also have access to CPRD.
- Our nimble team comprising pharmacoepidemiologists, clinicians and biomedical scientists, has a good understanding of the relevant European regulatory requirements.
- We handle the whole study process from initial discussions, through protocol writing and data collection, to production of a final study report. Further details are available here.
DSRU Consultancy provides advice on strategies, study designs and options for post-marketing Pharmacovigilance, Pharmacoepidemiology, Risk Minimisation and Risk Management Planning. For more information, click here.
Drug Safety. April 2016, Volume 39, Issue 4, pp 323–333
British Journal of Clinical Pharmacology, May 2012; 73(5):801-11
Drug Safety. 2020. https://doi.org/10.1007/s40264-020-00952-1
Drug Safety. 2020. https://doi.org/10.1007/s40264-020-00966-9
BMJ Evidence-Based Medicine Published Online First: 24 February 2020. doi: 10.1136/bmjebm-2019-111295