Our dynamic systematic benefit-risk analysis of antiviral drug combination lopinavir-ritonavir for COVID-19 patients has just been published. Our research team found there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19. This semi-quantitative analysis used the Benefit-Risk Action Team (BRAT) framework. The exposure of interest was lopinavir-ritonavir treatment in severe COVID-19 compared to standard of care, placebo or other treatments. In comparison to standard of care, data for several key benefts and risks were identifed for lopinavir-ritonavir. Risk data suggested a possible decrease in serious adverse events. There was a reduction in acute [...]
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A new consortium to monitor the safety and effectiveness of COVID-19 vaccines has been formed by the Drug Safety Research Unit and MEMO Research, University of Dundee. Developers of vaccines are required to demonstrate quality, safety and efficacy for their products before members of the public start receiving them. Therefore it is necessary to conduct post marketing observational studies to monitor the safety and effectiveness of COVID-19 vaccines to fill any gaps in knowledge obtained from premarketing clinical trials. It is important that these studies report in real-time any safety or lack of effectiveness signals so that action can be [...]
Remdesivir for COVID-19 patients is ‘favourable’ says first systematic benefit-risk study We have just published the first ever systematic benefit-risk analysis of antiviral drug remdesivir for COVID-19 patients. The analysis found a ‘favourable’ profile overall, though there is currently limited safety data available. The study was published on 28th May in the journal, Drug Safety, and recorded all possible benefits and risks for COVID-19 patients receiving remdesivir obtained by evaluating public data from peer reviewed journals and some pre-publication clinical trial data. We found benefits of remdesivir including quicker recovery time, with one study showing median recovery time for remdesivir patients [...]
Our article in the Spring edition of Pharmafile explains our unique SCEM method for conducting PASS studies in hospitals and specialist care in the context of rivaroxaban. The DSRU developed a unique methodology to conduct Post-authorisation Safety Studies (PASS) in hospitals and specialist care in the UK, known as Specialist Cohort Event Monitoring (SCEM) in 2010 (see reference below). This technique was developed to address the need for safety studies in secondary care, specifically for patients who receive initial or all drug treatment in hospitals or hospital outpatient clinics. This method is ideally suited to conducting PASS studies on Direct Oral Anticoagulants, [...]
by Saad Shakir (First published as a BMJ Rapid Response on 12th May 2020) A key component of efforts to control COVID-19 will be an effective vaccine. There are many potential COVID-19 vaccines in preclinical development and clinical trials around the world. History has shown that the benefits far outweigh risks for vaccines of infectious diseases. The normal vaccine development process including clinical trials may take 10 - 15 years. To address urgent public health need, such as the COVID-19 pandemic, the vaccine development process can be dramatically shortened to as little as 12-18 months, including testing and release. To protect [...]
How pharmacovigilance needs to adapt in order to handle the challenges of advanced therapies and the COVID-19 pandemicdsru2020-05-06T13:42:43+00:00
Saad Shakir writes: Pharmacovigilance has expanded in the last 10 to 15 years, shifting from low-level regulatory compliance to a more proactive approach. This is largely due to the 2012 EU legislation expanding the scope of pharmacovigilance to include risk management, risk minimisation and the introduction of reporting systems such as EudraVigilance in Europe and Sentinel in the US. These changes are of benefit to public health, ensuring that potential health risks or adverse events are identified quickly in conventional medicines, allowing swift action to be taken when needed. However development of pharmacovigilance needs to keep up with introduction of novel [...]
The DSRU team is heavily engaged in conducting studies related to the COVID-19 pandemic. 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. Inevitably clinical trials on these products will be shortened, so it will be essential to monitor the effectiveness of these new treatments at the post-marketing stage. Our preparations to provide near real-time intensive monitoring of new COVID-19 vaccines are well underway and we are in touch with stakeholders in order to form a consortium. This builds on our experience [...]
The DSRU team is used to working remotely while maintaining high standards and completing studies on time. We have the connectivity to enable us to remain open for business, conducting our current work and accepting new business as usual. We welcome enquiries about potential new studies and projects and will continue to handle them in the usual way, including discussing your requirements with you online, by email or phone. Please do not hesitate to contact us.
Professor Saad Shakir writes: What are Cytokines? Cytokines are a group of proteins that are secreted by cells in the immune system. They act as chemical messengers to regulate other immune cells. Cytokines are released from one immune cell to affect the actions of another cell in the immune system by binding to receptors on its surface. Cytokines include interferons, interleukins, lymphokines and tumour necrosis factors. Cells which release cytokines include macrophages, lymphocytes (both B and T lymphocytes) and other immune cells. Cytokines exert their effects in tissues locally or circulate in the blood and lymph. The difference between cytokines [...]
Pharmafocus published an interview with our Director, Saad Shakir, in its March issue, focusing on the need for pharmacovigilance to evolve in order to handle the challenges posed by scientific innovation and political upheaval. While we have seen a shift to more proactive pharmacovigilance, we will need further modification of existing methods, especially for biologic therapies where patients tend to be sicker, taking many medicines and suffering concurrent illnesses. Read the article in full here: https://en.calameo.com/read/0061133857c3d689fd31b?page=16