Drugs and medical devices are products of intensive research and development; there can be no medical progress without research. And as products of science, they must undergo a lot of clinical trials in order to confirm their efficacy.
But while test patients volunteer to participate in such trials of their own free will and consent, they can still be at risk from potentially incomplete and/or virtually untested products. Lives are literally on the line when it comes to clinical trials, and life science companies will need the appropriate coverage to protect themselves from the fallout of a botched test.
Insurance Business approached CNA’s Michael Brennan and Ruth Stewart – senior underwriter of healthcare & life sciences and senior risk control consultant for healthcare, respectively – to listen to their insights about clinical trials, and how the insurance industry approaches insuring them as the COVID-19 pandemic continues to complicate health matter everywhere.
Listen now: The state of the life science market
When asked what the common challenges faced by life science companies conducting clinical trials, Stewart listed several exposures apart from just having to deal with a failed trial.
“Probably the biggest challenge has been recruiting and retaining participants in the clinical trial. And those participants could be either a health volunteer, a patient with a disease that is being affected, probably, by a drug, or a combination thereof,” the senior risk control consultant said.
That participant problem only magnified during the COVID-19 pandemic, Stewart explained.
“Specifically in the pandemic many trials were delayed because it was impossible to recruit anybody, because of all of the limitations in getting together. Border closures, etc.”
Another problem plaguing clinical trials is retention, Stewart added.
“Clinical trials can run for a very long time and patients/volunteers will drop out. They cannot be bothered to travel to a testing site, they lose interest, or it’s just too much of a hassle for them to continue their participation in the trial.”
Stewart explained that being unable to retain clinical trial participants can cause problems for the life science company involved, since it might not hit the target number of participants for testing, setting back the trials until enough volunteers can be secured. At worst, companies may have to cancel the trials completely if there are not enough willing patients.
The complexity of the clinical trials themselves can be a challenge enough for life science companies, stated Stewart, pointing out that having the right skilled workforce to help administer the trials is tricky.
“Taking time away from, particularly, the clinical people (the physicians, the nurses) to be a participant in running a clinical trial site – that’s lost revenue for them. And therefore just the recruiting of people to be involved in looking after the trials is just becoming more of a challenge."
Stewart also prefaced that medical drug and device regulation can differ across jurisdictions, which adds another layer of complexity.
“Compliance with the regulation throughout the life of a trial is also a difficulty, because rules are changed across geographies. Therefore, if you’re running clinical trials – as is often the case in many different geographies – everybody in that geography has to be aware of what are the rules here that [they] must be attuned to and well-informed of so that they can be enforced throughout the course of the clinical trial.”
Listen now: The state of the life science market
