Approval of medicines must be expedited safely
There are currently no medicines in any country that have regulatory approval for the treatment of COVID-19 infections. Treatments currently under investigation to treat COVID-19 infection, and the pathologies arising from this infection, include licenced medicines and products under investigation for other conditions that may be effective (repurposed) for use in COVID-19 infection. There are also completely new products in development. The potential advantage of using an already licenced medicine, or one that is part-way through clinical trials is that there will be existing knowledge about the safety profile and so, it should take less time to get these approved for treating patients. However, it remains important to use pharmacological principles to define the safe and effective doses and treatment protocols for COVID-19 patients for all potential treatments - irrespective of whether these are new or repurposed.
The large-scale international trials that are currently underway will be critical in understanding whether treatments are likely to work safely. It is crucial that hospitals and associated healthcare staff are allowed and supported to recruit patients to such trials in a timely manner, reducing bureaucracy whilst ensuring Good Clinical Practice standards are upheld. This seems to be happening effectively at the moment as evidenced by the fact that the RECOVERY trial managed to recruit over 4000 patients in 4 weeks, and is in fact, the fastest recruiting trial ever undertaken in the NHS. The Society welcomes the swift action of regulators (such as the MHRA) and other organisations who are working to safely expedite trials.