Change Management in Clinical Trial Operations: Putting People Before Process

Matthew Harrington, Freelance Contributor

Clinical Researcher—May 2018 (Volume 32, Issue 5)


Matthew Harrington

[DOI: 10.14524/CR-18-4027]


Imagine if a career staff member of your local hospital was told by management to prioritize high-risk patients and check on others later—or not at all.

For many clinical research professionals, this is an unsettling yet familiar scenario. They face a similar dilemma given efforts to implement the risk-based guidelines for Good Clinical Practice (GCP) issued by the International Council for Harmonization (ICH) in November 2016.

ICH GCP E6(R2), as the guidance is known, causes some unease among clinical researchers, says Pam Weppler, leader of the Process Improvement Program at Rho, a clinical research organization in Chapel Hill, N.C. Drug development hinges on “safety and efficacy, and people are used to being really meticulous,” she notes.

For many people in clinical operations, the new ICH call to “increase efficiency” by focusing on “relevant activities” runs counter to their years of experience and training.{1} The prospect of “not covering everything is really scary,” Weppler says.

Clarifying the Personal Impact of Change

Change is hard, ever present, and increasing at a rapid pace. Driving change within the clinical research enterprise are powerful forces, ranging from new definitions of pharmaceutical value to shifting health policy and regulations.

When “change management” programs redefine risk management or make other radical adjustments within an organization, there is urgent need to ensure people understand what the change means to them personally, says Weppler, one of three speakers from Rho who presented the session “A Change (Management) Would Do You Good” at ACRP 2018.

The field of change management is a relatively new discipline and the evolution in putting people first shows its growing maturity. Highlighting the business necessity of change while explaining its personal impact cushions the blow, and is crucial to putting people at the center of a structured change management process.

For clinical research professionals experiencing significant change brought about by ICH GCP E6(R2) or other regulatory guidance, there’s a need to know how it will affect them day to day. This can take time to understand and explain, so adept organizations give people room to adjust by starting early and introducing the impact gradually when possible.

Change is Not Just a Moment in Time

Of course, gradual implementation isn’t always an option. Change is the only constant in clinical research. It can come suddenly when a new executive team takes the helm, or during a reorganization, or when some external event turns the status quo on its head.

Whether change comes at once or over time, however, there is a common tendency to first manage the process and then consider its effects on people. This perspective is pervasive when there are firm deadlines for a new technology, such as a clinical trial management system that reorders existing workflows as part of a larger change process.

“It’s easy to think of change as one event,” says Weppler’s colleague Ryan Bailey, a senior clinical researcher at Rho and co-presenter at ACRP 2018. For example, in a technology implementation, people look at the implementation schedule and think, “The day the system is live is the day the change is done,” Bailey notes. “We have been trained to focus on the new features, functions, and capabilities of a product. But what we should really focus on is implementation, product roll out, and change management, which is much more important to achieving the desired outcomes, and extends far beyond the date the system is live.”

When implementing new regulatory guidance, it’s easier to focus on “how we need to make the change, rather than why we need to make the change. The psychological part of change gets lost,” Bailey says. In most cases, change is “not a moment in time,” he adds. “It is a long process from beginning to end with people embracing it at different rates.”

Case Study

As veterans of many large-scale change management programs, Weppler and Bailey have found success implementing change through stakeholder groups in clinical operations. For example, in one program to consolidate 90 federal clinical research projects, they worked through study team leaders in project management, data management, statistics, and pharmacovigilance.

Engagement plans designed to implement gradual change should start three to six months prior to the launch of a new program, Weppler says. Leadership and stakeholder engagement represent one of the four main components of change management, alongside organizational landscape, communications, and training. Many companies miss the full value of these “soft skills,” Weppler notes, emphasizing communications and training over engaging stakeholders and ensuring change projects don’t collide with other priorities in the organizational landscape.

The Rho consolidation project served as a case study example of change management during Weppler and Bailey’s ACRP 2018 presentation, illustrating how the two overlooked components of change management—stakeholder engagement and organizational landscape—can be more fully executed. This includes engaging with company leaders who sometimes need a special push to get on board a new initiative, and direction for timing their activities for maximum impact.

This isn’t to say communications and training are less important in change management, just more easily understood at a surface level. The Rho case study went deeper to explore how the change leaders served as a vital link in bringing these components to life. It revealed how Rho leadership worked to make sure the story of change was the same no matter where people ventured in the organization, to train their stakeholder groups on new policies and procedures, and, most importantly, to help those who were struggling to adapt.

Expect Friction

Rho is a project-based organization, so responsibilities will differ within traditional company structures, but the lessons learned in change management are broadly applicable. One of the most valuable lessons to emerge from this change project, and others conducted at Rho, is the importance of understanding how and when people embrace change—or resist it.

At the ACRP 2018 session, Weppler and Bailey discussed how to respond when confronted with aversion to change, when employees are reluctant to give up trusted methods while an organization is attempting to implement new procedures or programs.

“The first thing is to realize this is natural,” Bailey says. “Regardless of whether it is perceived as positive or negative, every change experiences some degree of friction, challenge, and resistance.” According to Bailey, the key is realizing that even negative emotions and behaviors are natural human responses to which one should respond with empathy.

Some change management experts recommend segmenting people by their level of engagement to understand points of resistance or acceptance, using categories such as ambassadors, champions, thieves, and saboteurs.{2} To understand where people stand along the change continuum, Rho conducts a readiness assessment throughout the course of a change project. Sent to the entire population of people involved in a change, the assessment provides a pulse check, offering a granular view of the functional areas where people are struggling. With the results in hand, change leaders are better able to help their people adapt.

Dip Ahead

If the readiness assessment reveals active resistance, it’s an opportunity for change managers to work more closely with affected individuals, Weppler says. An “initial dip in morale and productivity” is inevitable, she notes. When individuals express frustration, effective leaders “hear them out to give them safe spaces” for speaking their minds and moving through resistance at their own pace, she says. Often, the people who are more vocal are a great asset, because they will raise questions that others are hesitant to ask.

Leaders in clinical operations, typically change champions, are key to stakeholder engagement. To select these leaders for the Rho program consolidation, Weppler and Bailey looked for people with both organizational experience and employee trust. Keeping these people engaged in the process is a challenge due to the many demands on their time. However, their time crunch can open opportunities to involve people in expanded change management roles, Bailey says.

For instance, the head of a department may have the willingness but not the time to engage, but his or her second-in-command might have both. Or two department heads could join forces with one of them leading both groups. Educating a new generation of leaders is essential to the change management discipline.

In 20 years, we may look back and wonder, “Didn’t the world move at a much slower pace back then?” What will be different in the future is the maturity of change management itself. As it continues to evolve as a formal discipline within clinical research, change management will grow in effectiveness as more professionals see its value in making their work life less turbulent.

Editor’s Note: You can read more about Rho’s effective stakeholder engagement tactics in the ACRP blog, When Big Change is Coming, the Little Things Matter.


  1. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). 2016. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
  2. Wyles G. 2013. The eight personalities involved in change management programmes.

Matthew Harrington is a freelance writer and consultant with Worldwide Clinical Trials.