Standards and guidance for clinical research relating to COVID-19 are urgently needed to ensure trial data are meaningful
Currently, many studies that are running are not of high enough quality to generate meaningful data. Standards and guidelines to support properly designed and appropriately powered studies are urgently needed.A particular challenge is the data arising from compassionate use studies. Compassionate use is defined as the use of an unlicensed therapy to treat a patient because there are no other treatments available. Compassionate use, however, often leads to poor quality data and should be treated with extreme caution with regard to efficacy and safety of drugs. We therefore strongly support the UK Government’s view that wherever possible patients should be entered into clinical trials.
However, it is likely that some patients will be treated on a compassionate use basis. Given the pressing need for high quality research and that large-scale studies will take longer to report, the Society supports the WHO guidelines on compassionate use if assessment within the context of a clinical trial is not possible. Standards that specifically focus on how to run high quality, small-scale studies are particularly needed to ensure that they have the best chance of informing treatment protocols.
A further complication is that the COVID-19 disease state may be thought of in two phases: the initial viral infection/replication stage and the later ‘cytokine storm’ immune phase that is only experienced by a subset of patients but is the major cause of fatalities. It is important that patient groups are well-defined in any study.Useful standards and guidelines are likely to include randomisation of treatment protocol, stratification of different patient populations and the use of appropriate clinical endpoints. The Society and our journals are currently working with experts to help define these parameters and we will update this page when the guidance is available.