When Failure is Not an Option

Air travel is really safe. You have a greater chance of being struck by lightning or attacked by a bear while you read this article than dying on a US commercial flight. That’s because the odds of dying in the US commercial plane crash are near zero* (approximately 50 people die from lightning a year in the US and 17 get attacked by a bear **). This has not always been the case. Air travel used to be dangerous but the technology we use to train and support our pilots has nearly eliminated pilot error. It would be unthinkable not to train pilots through simulation these days.

In stark contrast, pharmaceutical companies invest hundred of millions of dollars in new drug development in order to bring life-saving medications to market, and yet how do we train the people that are responsible for making these massive clinical trials happen? Are they using advanced technology such as simulations? Sadly, no. A lot of these companies are using “old school” methods, such as lectures and slides. Imagine if that is how we still trained our pilots on new aircraft. Personally, I would be taking a lot more trains.

Today I heard another example of a study that was unblinded and when the data was examined, it was determined that the site staff were improperly trained, had made too many mistakes, and the study had to be repeated. This is not an uncommon occurrence. Several companies are now augmenting their training using virtual and physical simulation techniques for the benefit of site staff. This provides an additional advantage of being able to assess competency, predict errors before they happen and measure improvements in skill – none of which can be effectively achieved using didactic training methods such as lectures and investigator meetings.

With clinical development success rates dropping to 10%, we should have a near-zero tolerance for human error derailing a study. One way to accomplish that is by using modern human performance management techniques such as simulation training.

David Hadden is Chief Game Changer at Pro-ficiency, a leading provider of online simulation training for clinical trial sites, CRAs and Study monitors. In previous lives, he brought to market the fields of VPS (virtual patient simulation) and ROI tools for human performance interventions. His previous company installed hundreds of medical simulation centers in Africa and trained over a million doctors in 190 countries through simulation. He collaborates with his Co-CEO, JoAnne Schaberick, in his latest endeavor, Pro-ficiency, which uses simulation to improve study quality while reducing cost and time.

*https://thepointsguy.com/2015/02/how-safe-is-air-travel-the-statistical-truth/ “Without minimizing the tragic loss of even a single life as a result of any airline crash, I would still argue that you are safer onboard a commercial airplane in the United State than you are at virtually any point in your entire life.”

** NOAA Data https://en.wikipedia.org/wiki/Lightning_strike