Overcoming Complexity-Change-Challenge


Use the five stages of change model to solve this common paradigm in clinical trials.

Brian S. McGowan, PhD

Brian S. McGowan, PhD

In my first article in this series1, I suggested that many, if not all, of the risks, delays, deviations, cost-overruns, and burdens associated with contemporary clinical trials share a singular root cause—simply put, they are undermined by challenges with change management. I also suggested that embracing this singular root cause is a critical, positive first step in moving the clinical research community forward, given the vast knowledge accumulated over the past 50 years in the cognitive, learning, and behavioral sciences to overcome these challenges efficiently and effectively.

So perhaps you can imagine my joy and satisfaction to subsequently read the article by Braude and colleagues, entitled “How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and Retention”; just a few weeks later in which they present a series of recent change management experiments addressing the unique clinical trial challenges of patient recruitment and retention with a unique cognitive science best practice.2

In this second article in our series, I would like to step back to the most basic, foundational science of change management - then in forthcoming articles we will revisit the work by Braude and others to equip the clinical research community with a comprehensive set of techniques to expedite trial planning, site selection, start-up, enrollment, and execution

The Complexity-Change-Challenge Paradigm

If you take away nothing else from this series, every time you hear someone discuss the “complexity” of contemporary clinical trials I want you to pause and think: “change.” And every time you think of “change” associated with contemporary clinical trials, I want you to pause and think: “challenge.” Committing to this word association will help you paint the simplest picture of what we, as a professional community, are up against.

For trials to be successful, trial stakeholders need to change the way they think, behave, and perform in accordance with clinical protocols and goals and related responsibilities. The more complexity, the more change. The more change, the more challenge. Feel free to scratch down on a post-it, “Complexity-Change-Challenge Paradigm” and slap that bad boy right next to the touch pad of your laptop!

Once you’ve embraced the Complexity-Change-Challenge paradigm, you might also pause and reflect when you hear the term “stakeholders.” The word seems to be fairly ubiquitous in the clinical trials community, but as a collective term, it over simplifies what is a far more diverse and heterogeneous set of individuals. Individuals who work for sponsors. Individuals who work for CROs. Individuals who work for sites. And, of course, the individuals who consent to participate in clinical research - the patients.

And here is one of the first lessons we learn from decades of change management science - change is an individual journey. To overcome the Complexity-Change-Challenge paradigm, we must avoid seeing change as a yes/no dichotomy across a broadly homogeneous population. Instead we must understand the readiness of each individual stakeholder and where they lie within the stages of change.

Stages of change

The Stages of Change model was originally proposed in the late 1970s, first published in the early 1980s, and has now been investigated and replicated for over four decades. 3,4,5 In short, the model presents the five stages that an individual must navigate in order to change.

Stage One: Precontemplation

In the precontemplation stage, individuals are not thinking seriously about changing and may be defensive in the face of efforts to pressure them to change. Individuals spend most of their lives here…blissfully unaware.

Summary: Precontemplation = Not yet acknowledging that change is necessary.

Stage Two: Contemplation

In the contemplation stage, individuals are weighing the risks and benefits of change and considering the long-term benefits versus short-term costs. This decision making might take a few hours, weeks, or even longer.

Summary: Contemplation = Acknowledging the possibility of change but not yet ready to change.

Stage Three: Preparation

In the preparation stage, individuals have made a decision to make a change. They can often articulate the reasons and drivers for change. And they are actively planning to change, looking to answer questions of how and when. This is a critical stage, but it does not guarantee change will occur and, as with contemplation, this planning might take a few hours, weeks, or even longer.

Summary: Preparation = Getting ready to change.

Stage Four: Action

In the action stage, individuals are actively taking steps to change - though they often struggle with the change itself and are therefore at significant risk for failure. Fortunately, individuals in the action stage tend to be open to receiving help and are also actively seeking support from others. This can be the shortest stage, but if the change is more complex, it too can take weeks-to-months to stick.

Summary: Action = Changing behavior.

Stage Five: Maintenance

In the maintenance stage individuals attempt to maintain the new status quo and avoid relapsing to prior choices and behaviors. Intention is key in the maintenance stage as new choices and behaviors are nascent and not well grounded.

Summary: Maintenance = Sustaining the behavior change.

As mentioned earlier, the Stages of Change model has been investigated and replicated in research studies for more than 40 years, and perhaps the most important lesson it teaches us is that our “stakeholders” in change - those needing to change specifically - will populate different stages at different times. However, for successful change to occur, the full stakeholder population will need to be supported and scaffolded in ways that allow them to move through the action stage (stage 4) and into the maintenance stage (stage 5). Each individual stakeholder will likely have a different starting point, a different pace of change, and need different training. scaffolds, and supports.

Fortunately, much of the 40 years of investigation and replication of the Stages of Change model has helped to identify the varying techniques best suited for each stage.6 These techniques are summarized in the figure below.

Empowering Change within Contemporary Clinical Trials

As noted above, there are literally hundreds of changes required for the successful execution of increasingly complex, contemporary clinical trials and each change creates a different challenge(i.e., the complexity-change-challenge paradigm). Importantly, these challenges are magnified because each individual stakeholder faces their own unique journey through the stages of change. And even the most conservative math would suggest that any given phase III trial can easily include thousands of individual stakeholders needing to change. The Stages of Change model serves as a roadmap by which we can understand the process of change and highlights the heterogeneous nature of change but it also emphasizes a critical obligation of those that plan and lead research trials: without supporting the change journey and without ensuring the readiness of the individual, you are leaving change to chance.

While Braude and colleagues provide fascinating insights into specifically addressing the change management challenge with patient recruitment and retention, there are countless other similar opportunities.From improving the accuracy of site selection, to the deployment of resources to accelerate start-up, to training and upskilling site staff. Ultimately, each of these is improved through the applied research in the cognitive, learning, and behavioral sciences. Perhaps the simplest way to summarize this is as follows: Ensuring that each individual stakeholder can think more logically, learn more efficiently, and perform more effectively, no matter where they are on their change journey, is our surest path to clinical trial success.


1. https://www.appliedclinicaltrialsonline.com/view/singular-root-cause-undermines-clinical-trial-success-leveraging-best-practice-from-50-years-of-applied-research

2. https://www.appliedclinicaltrialsonline.com/view/how-sponsors-can-use-health-decision-science-to-improve-clinical-trial-recruitment-and-retention

3. https://pubmed.ncbi.nlm.nih.gov/6863699/

4. https://pubmed.ncbi.nlm.nih.gov/8168470/

5. https://pubmed.ncbi.nlm.nih.gov/30335193/

6. https://www.cpe.vt.edu/gttc/presentations/8eStagesofChange.pdf

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