At recent conferences I’ve attended and presented at, the topic of critical thinking has come up. At the MCC Summit, there was consternation that apparently some senior leaders think the progress in Artificial Intelligence will negate the need for critical thinking. No-one at the conference agreed with those senior leaders. And at the Institute for Clinical Research “Risky Business Forum”, everyone agreed on the importance of fostering critical thinking skills. We need people to take a step back and think about future issues (risks) rather than just the pressing issues of the day. Most people (except those senior leaders) would agree we need more people to be developing and using critical thinking skills in their day-to-day work. We need to teach people to think critically and not “spoon-feed” them the answers with checklists. But there’s much more to this than tools and techniques. How great to see, then in the draft revision of ICH E8: “Create a culture that values and rewards critical thinking and open dialogue about quality and that goes beyond sole reliance on tools and checklists.” And that culture needs to include making sure people have time to think critically.
Think of those Clinical Research Associates on their monitoring visits to sites. At a CRO it’s fairly common to expect them to be 95% utilized. This leaves only 5% of their contracted time for all the other “stuff” – the training, the 1:1’s, the departmental meetings, the reading of SOPs etc. Do people in this situation have time to think? Are they able and willing to take the time to follow up on leads and hunches? As I’ve mentioned previously, root cause analysis needs critical thinking. And it needs time. If you are pressurized to come up with the results now, you will focus on containing the issue so you can rush on to the next one. You’ll make sure the site staff review their lab reports and mark clinical significance – but you won’t have time to understand why they didn’t do that in the first place. You will not learn the root cause(s) and will not be able to stop the issue from recurring. The opportunity to learn is lost. This is relevant in other areas too, such as risk identification, evaluation and control. With limited time for risk assessment on a study, would you be tempted to start with a list from another study, have a quick look over and move on to the next task quickly? You would know it wasn’t a good job but hopefully it was good enough.
Even worse, some organizations, in effect, punish those thinking critically. If you can see a way of improving the process, of reducing the likelihood of a particular issue recurring, what should you do? Some organizations make it a labyrinthine process to make the change. You might have to go off to QA and complete a form requesting a change to an SOP. And hope it gets to the right person – who has time to think about it and consider the change. And how should you know about the form? You should have read the SOP on SOP updates in your 5% of non-utilized time!
Organizations continue to put pressure on employees to work harder and harder. It is unreasonable to expect employees to perform tasks needing critical thinking well without allowing them the time to do so.
Do you and others around you have time to think critically?
Text: © 2019 DMPI Ltd. All rights reserved. (With thanks to Steve Young for the post title)
Picture: Rodin – The Thinker (Andrew Horne)