The important role of patient safety in the urgent search for an effective COVID-19 vaccine
On International Clinical Trials Day Gene Matthews, partner at Leigh Day, who specialises in clinical trial claims, and Nancy Williams barrister at 5 Pump Court Chambers, discuss the role of patient safety in the search for a Coronavirus vaccine
Posted on 20 May 2020
- Lopinavir-Ritonavir (commonly used to treat HIV)
- Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation).
- Hydroxychloroquine (related to an anti-malarial drug)
- Azithromycin (a commonly used antibiotic)
- Tocilizumab (an anti-inflammatory treatment given by injection)
Generally, the use of known treatments without established efficacy to treat a condition poses a real risk to patient safety because it is unknown whether use of the treatment will improve patient health or have the opposite effect. Similarly, when a drug is in its developmental stage the unknown effects of the drug may pose a high risk to patient safety. The use of these types of treatments is primarily supported on theoretical and/or speculative grounds. For example, within the context of COVID-19, there has been some buzz generated within the scientific community regarding the use of hydroxychloroquine to treat the virus, although there are divergent views regarding its efficacy as a potential treatment for the virus due to the lack of clinical data supporting the same. Nevertheless, at this stage, it is fair to say that in relation to the COVID-19 crisis, the prospect of finding a clinically viable cure for the disease appears remote and the risk to patient safety of proposed treatments is unknown.
Notwithstanding concerns regarding the speculative use of treatments and the corresponding risk to patient safety, in exceptional circumstances (such as the present) when confronted with a global health pandemic, there is emphasis on the urgent need to find effective treatments. Therefore, time is of the essence. The balance between patient safety and the collective interest shifts in favour of the collective interest in finding a remedy for the disease. Arguably, the scale of the pandemic and the high mortality rate strongly supports testing unknown treatments. With the pressing need to find effective treatments at the forefront, it raises legitimate concerns about whether individual patient safety is being sacrificed for the collective good.
It is clear that the procedure for conducting clinical trials will have to adapt to the current circumstances. However, the challenges presented by the pressing need to find effective treatments or a vaccine should not compromise patient safety. It appears that there are mechanisms in place to ensure that ethical standards continue to be maintained during this time. Patient, and volunteer, safety must (even in these most challenging and uncertain times) be at the centre of drug development.