Last week I was on a climbing trip in Austria. At the most challenging part of the climb, I found myself 2000 meters above ground on an overhanging cliff (thanks to my girlfriend for taking the awesome pic above). While in this apparently precarious situation, I was entirely focused on my personal risk (as any sane person would be). However, my risk was very well identified and managed. I was tied in at multiple points and the moves I needed to make were well within my capabilities. I would have been in more danger painting on a 20-foot ladder.
Exposing risk and understanding it is also 90% of the battle when it comes to risk management in clinical trials. Clinical research operations are driven by predicting, preventing and managing the risk of hundred million dollar trials, and yet there is a big chunk of ill-defined risk in clin-ops that often results in huge costs and delays: human performance variance. It is here where enrollment suffers and protocol violations occur and it is one of the reasons that there are no economies of scale in trials – the more trials you conduct, the more expensive each one becomes(1). However, the human performance variance is also the richest treasure trove of recoupable cost and time. So, why does the industry keep using the same inefficient management systems to manage the largest expense – people?
With so much of the success of a study relying on human performance, we should be using better tools to manage and predict that risk element; tools that will not only increase the accuracy of the trial but cut millions in costs, weeks or months of time and that massively reduce protocol violations. This tool is simulation, the state of the art for human performance management (think pilots, supertanker captains and the military). Is it not time for the tools we use for clinical trials to be as innovative and high-performing as the products they test? We have to be careful to not squeeze so hard in our efforts to create cost efficiency, that there is no room for innovation and transformation. Let’s get off the ladder and onto the mountain!
Dave Hadden, Co-Founder and Chief Game Changer at ProPatient and ProCT.
(1) For companies that have launched more than three drugs, the median cost per new drug is $4.2 billion; for those that have launched more than four, it is $5.3 billion. Even if a company only develops one drug, the median spending is still a hefty $351 million. – Matthew Herper, Forbes, August 11, 2013