Guiding Principles of Change Management in Clinical Research

Mel Johnson
July 25th, 2018

In the age of technology, it’s becoming more and more critical for organizations to be adaptable and nimble to keep up with an ever-evolving environment. Particularly in clinical research, new systems and technologies, like wearables, sensors and artificial intelligence, are continuously entering the research arena, requiring organizations to be agile in order to stay competitive. In addition, major organizational changes, such as management-level turnover or structural changes require resiliency and can have lasting effects if handled poorly.

Managing the effects of such changes can be difficult. During this year’s 10th annual AACI-CRI conference at the Loews Chicago O’Hare Hotel, keynote presenter, Kimberly S. Scott, PhD, from Northwestern University, discussed how clinical research organizations can establish successful change management practices. In her compelling and interactive presentation, Kimberly outlined how organizations can successfully implement new changes while minimizing negative consequences, like staff turnover or lack of adoption.

Throughout her talk, one of the best analogies that Kimberly shared that we can relate to is describing change as a marathon. She noted the people in the marathon that take off running first are like the leaders at an organization, running quickly with nothing in front of them. At the back of the race corral are the rest of the runners, jogging in place, waiting for the front runners to move through.

It’s like this at our organizations – leaders know about change, and have been talking about it, so are familiar with the concepts. But, leading that change through the rest of the organization is important, and if you take off on your marathon and forget about those in the back, you’re sure to run into some roadblocks.

So, here we dive into a few of Kimberly’s guiding principles for successful organizational change management.

Know your biases and check your assumptions

During any significant change, it’s important for leadership to provide direction and resiliency. However, our attitudes towards a change can significantly affect how resilient we are. It’s easy to let perceptions color the way we both understand and communicate a change. For example, if you encounter a change you perceive as negative, it’s likely your attitude toward the change will also be negative, and others in the organization may pick up on it. Whether you’re in a leadership role or not, it’s important to take time to understand what your biases about the change might be and set them aside. Do your best to communicate the change and its goals from a factual perspective and go forward with as much positivity as possible.

Extend empathy  

Empathy can be used to guide people through a change and the first step is to recognize that, for many, change is not easy. During her presentation, Kimberly showed the audience multiple models that identified common stages individuals often go through when presented with a change, including the Kubler-Ross Change Curve.

Kubler-Ross Change Curve

Kimberly explained that change can sometimes feel like a loss and even small changes can impact an individual’s perceived identity. Acknowledging that feeling of loss is a key step in guiding people out of the frustration and depression stages of the change curve to begin the upward slope to integration. Taking time to recognize how things were done in the past can help bring more closure and help people begin to accept what’s to come. As an example, she likened this acknowledgement to the inauguration of a new president. During the transition from one president to the next, the United States government takes the time to recognize our standing president and ceremoniously acknowledge the close of an era as the new president is sworn into office. 

Communicate with people often

Communication and empathy tend to go hand in hand, especially when communicating change. If you communicate without empathy, you begin communicating at people without listening to whether or not they understand the meaning. Communicating with people means having conversations early, often and in person to open yourself up for questions and concerns. It also means broadening your communication methods.

In her keynote, Kimberly explained that, even when you communicate the same exact thing to a group of people, different people in that group may glean different meaning. Take the popular “Laurel vs. Yanny” audio recording phenomenon as an example. Some people may listen to the recording and clearly hear the person say “Laurel,” whereas others may listen to that same recording and hear “Yanny.” Both of the individuals are confused by how the other could hear any other name than the one they heard so clearly. As Kimberly noted, exposure to frequency matters. When communicating a change, it’s critical to make sure you’re communicating at different “frequencies” to ensure everyone is on the same page. Start conversations to learn how people are understanding you and then adapt your “frequency” accordingly to ensure the message comes across clearly for everyone.

Amidst the complexity of the clinical trial process, it’s easy to forget that running successful (and hopefully profitable) research requires many of the same principles as a successful business. As Kimberly notes in her keynote presentation, change management is a critical part of any organization, allowing them to remain agile and adaptive in any environment. Check out this recent blog post to learn even more about the essential elements of facilitating productive change in your clinical research operations.


2 thoughts on “Guiding Principles of Change Management in Clinical Research

  1. I have a question that is slightly off topic from this.

    An often cited concern of large change within a organization is an accompanying change fatigue. This is often reported by the “laggards” group.

    (For background, the graph and concepts with the post above are often cited in reference to companies making a transition to Lean Management practices. Another graph that is often used is the Early Adopters to Laggards graph,

    Another often cited source when going through a large scale change to Lean Management/DevOps is Westrums Generative Culture (this article contains a link to the original whitepaper The Study of Information Flow: A Personal Journey, Westrum contends that when facing change, a culture that reacts to the change with inquiry and openness rather than control have a far better chance of adapting and resolving issues faster and more successfully. The key piece being that people are open to change and react with inquiry.

    I have a theory that, biologically speaking, a person that is more open to change and reacts with a greater likelihood of inquiry may have a greater level of serotonin (or whatever the affect that anti anxiety medications try to achieve).

    I was wondering if there have been any clinical studies of people who have gone through “talk” therapy (without, again, without the aid of medication) that focused on handling change with openness and inquiry that monitored the patients level of serotonin (or any neurotransmitter) throughout the study?

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