The COVID-19 pandemic has affected nearly every industry, with many measures intended to prevent spread i.e. social-distancing, masks, stay-in-place - remain firmly in place, significantly altering the way life is lived and business is conducted.
The pharmaceutical industry is no exception with clinical trials are underway to develop a vaccine and identify potential therapeutics. However, management of the virus continues to bewilder the world’s finest researchers and clinicians… and our traditional standards of pharmaceutical regulation have necessitated adaptation.
Solutions such as only staffing “essential” employees and conducting remote monitoring by designated “Qualified Persons” (QPs) have been identified as allowable options by regulatory bodies that include the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA). Many of these supposedly temporary solutions are already yielding positive results, which, as we discuss in our full-length article, may pave the way for future innovation.
This business agility impacts the field of pharmaceutical research, which has had to enact similar adaptations in order to carry out existing clinical trials and commence those related to COVID-19.
Some trials have been temporarily sidelined to make way for more urgent pandemic-related studies, while other projects still require time-sensitive monitoring. To this end, clinical trial personnel and research teams are creating workarounds based on their respective needs. That includes using remote monitoring techniques, developing drive-up patient testing, conducting patient home visits, or, similar to industry efforts, only staffing essential employees necessary for conducting non-automated tasks. These, and other, measures are proving valuable in protecting both patients and research teams.
These adaptations, as well as the others discussed in our full-length article on the effect of the COVID-19 pandemic on the pharmaceutical industry, demonstrate that while the pandemic poses a grave threat to human health and the economy, there are some positive lessons to be taken away from the situation. Namely, that while challenges necessitate adaptation, oftentimes those adaptations can lead to future successes.
Travel, retail, entertainment, healthcare, finance: the COVID-19 pandemic has affected nearly every industry. Of course, the pharmaceutical industry has a crucial role in responding to the COVID-19 crisis, so it is imperative to maintain business as usual whenever possible.