To meet the spirit of the IND safety reporting final rule, sponsors have developed processes and procedures to evaluate, assess and act on accumulating safety information during development on an ongoing basis – leveraging scientific expertise and medical judgment of multidisciplinary safety management teams. Multidisciplinary sponsor teams and independent assessment entities working together can protect the safety of patients while also protecting the integrity of the data, allowing clinical trials to answer the important questions they were designed to answer.
Now, let’s momentarily step outside of the pharmaceutical industry and approach this from another perspective; through lessons learned from the space shuttle Challenger disaster. Looking only at the quantitative data supported the decision to proceed with the launch; however, there was other important information the engineers presented. One engineer, when asked to “quantify” his concerns, couldn’t do it. He knew that on a 75-degree flight, there was a “very thin streak of light gray soot beyond an O-ring in the joint” and that on a 53-degree flight, there was “jet-black soot fanned out across a large swath of the joint”. Furthermore, on the morning of the launch, there was ice (another 20-degrees colder) on the space shuttle. He had no data to “quantify” his concern. He had important information, but it was not quantitative – so the NASA engineers didn’t know how to make use of it. Significantly, he did say he knew that it was “away from goodness”. We need to be able to incorporate subject matter expertise (medical judgment) into our safety decisionmaking process.
Epstein D (2019). Range: Why generalists triumph in a specialized world. Riverhead books.