Will COVID-19 have a short-term impact on clinical studies?
The global outbreak of coronavirus (COVID-19) and current misinformation infiltrating our consciousness on social media has been a challenge to get our heads around, but it’s undeniable that there’s a public health risk currently proposed by the pandemic. With Italy in lockdown and other countries possibly following suit, will this outbreak impact ongoing clinical studies and those currently enrolling patients?
At the time of writing, it’s unknown how coronavirus spreads from person to person. It’s possible it spreads in cough droplets, like similar viruses. If an individual is advised to self-isolate, whether due to contracting the virus, or coming into contact with someone who has the virus, this will likely have a knock-on effect on clinical studies. People who are currently participating in clinical trials will be unable to attend appointments, and potential participants will be unable to be screened and more hesitant about joining.
The challenge with any clinical study is that every site visit is dictated by the protocol, which has been EC/IRB approved. However, there are options to improve participation that account for the current epidemic:
Increase opportunities to part by decentralising: introduce home visits or facilitate assessments through technology platforms
Partner with pharmacies and local health settings, who could assist with procedures such as blood tests
Post the investigative therapy directly to participants’ homes
These solutions are quick fixes that can ease the burden on healthcare and ensure clinical studies progress without disruption, but any protocol changes will need to be reported for EC/IRB approvals. For instance, the FDA regulations state:
“Each IRB must follow written procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity, and ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.”
Considering coronavirus is an immediate threat to the safety of people, it is grounds to make the appropriate changes to the study. IRBs should be notified as soon as possible to ensure changes are documented. If you have questions, please contact your local IRB representative and they should be able to help.
The coronavirus has raised some interesting points: why aren’t more studies partially decentralised? Why are pharmacies not able to do blood tests? Why is the investigational drug not shipped to the participant?
The clinical research industry should take learnings from this pandemic, have a period of introspection and work on improving the experience of sites and participants.