The Human Component Of Clinical Trial Technology Implementations

By Jeffrey S. Handen, Ph.D., and Lisa Cooney, Grant Thornton LLP

As part of our ongoing series about best-in-class approaches for rapidly assessing, prototyping, and introducing digital and other clinical trial technologies,¹ we focus our attention in this article on the “human” component of technology-enabled transformation. If the success of your project relies on people working differently, then it’s critical to consider early and often how best to help them manage the transition to the new approach. Unless we equip stakeholders with the information and knowledge necessary to adopt a technology, they won’t fully integrate it into their way of working. Often, that translates to longer and more costly implementations, lower productivity, and a frustrated workforce that may never realize fully the benefits you expected.

Unfortunately, a significant and unacceptable percentage of IT projects fail. According to a 2017 report from the Project Management Institute:

• 14 percent of all IT projects were total failures
• 31 percent didn’t meet their goals
• 43 percent were over budget
• 49 percent exceeded timelines²

Similarly, a Gartner survey showed 20 to 28 percent of all IT projects fail.³ And McKinsey’s data shows, on average, IT projects run 45 percent over budget while delivering 56 percent fewer benefits than predicted.⁴

In light of these challenging statistics, organizations need to pull every lever available to make projects more successful. Research has shown that projects with "excellent" change management in place were six times more likely to meet objectives than those with "poor" change management. Even projects using "good" change management were five times more likely to meet objectives.⁵

What Do We Mean By Change Management?

If you view the people side of change as a bit ambiguous, you’re not alone. But change management is actually very practical. Let’s use an analogy: Think about your transformation project as a road trip. We rely on project management to tell us which road we need to take, where we need to be, and when. But project management alone won’t make people feel committed to the journey. Many often take a detour. Change management helps us understand why we’re on the journey, what we need to do to prepare for it, and what will happen when we reach our destination. The obvious tools for change management are communications, training, and reinforcement. But for many, knowing when and how to apply these tools can be daunting. A few helpful tips can demystify change management:

• Plan early for deployment
• Consider the holistic change, not just technology
• Use pilots to test reactions to the solution
• Offer robust support after launch

Plan Early For Deployment

Long before implementation begins, project teams need to consider who will be impacted by a change and how. These factors are the best indicators of how much training and communication effort are needed. For example, if the change is simple, you may be able to take a basic approach to change management. But, in many cases, organizations miss warning signs that indicate when they need a stronger focus on communication and training:

• Many different stakeholder groups are involved and will be impacted differently
• The impact of the change feels significant
• The current way of working is heavily entrenched
• The change is complex or multi-dimensional (technology, roles, processes, etc.)
• Stakeholders have other significant change initiatives underway
• The consequences of stakeholders rejecting the solution would be high

When organizations consider these factors early, they can integrate training and communication into the project plan for a smooth deployment. It allows for reinforcement of key messages repeatedly and building of stronger awareness and knowledge over time. Project teams that don’t consider these factors early face a chaotic launch.

Consider The Holistic Change

As technology enthusiasts, it’s tempting to focus our attention on tools. But for most stakeholders, technology is a means to an end: They see it as an enabler to accomplish work. They often consider process, role, and organizational changes to be just as important as the technology. To really comprehend the change, stakeholders must have training that integrates all facets of the change. Even system demos should be delivered in context. Use cases and specific examples radically improve understanding. Preface the demos with a high-level view of the process and clarify who will perform each task.

Use Pilots

A pilot is often one of the most cost-effective mechanisms project teams can use to improve success. It has multiple benefits:

• Tests for early signs of commitment or resistance
• Creates a group of likely net promoters
• Identifies parts of the solution that aren’t effective or need clarification
• Reveals aspects of the change that will require more reinforcement when the change is deployed to the broader organization

Change adoption rapidly increases when stakeholders have a safe environment such as a pilot where they can gain hands-on experience. Simply inviting pilot team members to help shape the solution creates goodwill and makes it much more likely that they will be net promoters who advocate for the change when it is deployed to the broader organization. 

As highlighted earlier in the series, the Net Promoter Score (NPS) is a quick and simple way to measure how people perceive the effectiveness and benefits of the technology. Users simply rate the technology/solution via a survey on a scale of 1 to 10 and optionally provide supporting comments. People who rate the technology 9 to 10 are considered “Promoters,” while those who score it 0 to 6 are considered “Detractors.” People who give ratings of 7 to 8 are “Passives.” The NPS is calculated by subtracting the percentage of Detractors from the percentage of Promoters. Any score higher than zero is generally considered good; higher than 50 is considered excellent and higher than 70 is exceptional. 

To optimize the pilot experience, it’s important to collect feedback through tools such as the NPS, focus groups, and/or interviews and be completely transparent about how you’ve used the input. This feedback can be an excellent resource as you create deployment training and communication plans, since they will reveal areas of the solution where the team lacks clarity or commitment and further guidance is needed. The feedback can also serve as real-life success stories that strengthen the rationale for making the change.

Offer Robust Support After Launch

For project teams, launch day feels like a conclusion. While it’s important to celebrate this significant milestone, we also need to recognize that most stakeholders will view this as a beginning rather than an end. They need to climb the learning curve in the days and weeks after launch. The project team must plan for hyper-care support to answer questions and make adjustments after launch. They should also prescribe an approach to support stakeholders after the project team disbands. For example, they need to consider who will set and measure key performance indicators, who will onboard new employees to the process, and who will define changes to systems and tools after the project has closed.

Conclusion

Introducing change into any process, particularly ones as highly complex and regulated as clinical development, requires thoughtful preparation. We need a keen understanding of the impact of the change and early, frequent intervention to make sure people have the desire to make the transition. This desire to change must be strong enough to overcome the barriers to switching – not just the technical barriers common in “rip and replace” transformations, but also the natural resistance we feel when asked to change the way we’ve always done something. The development and implementation approach outlined in this series of articles does not require large investments or time commitments. On the contrary, the framework can produce initial positive outcomes in less than six weeks and further wins after a pilot phase. As time and budget pressures mount within R&D, taking this pragmatic approach to technology intervention can help your transformation succeed where so many others have failed.

 References:

1. “Assessing And Implementing Clinical Trial Technologies: A 3-Step, Adaptive Approach,” J.S. Handen, Clinical Leader, March 5, 2019
2. PMI’s Pulse of the Profession, 9th Global Project Management Survey, 2017
3. Gartner Survey, Why Projects Fail, June 2012
4. McKinsey and Company Survey, 2012
5. “Why Change Management,” Prosci, 2017

About The Authors
Jeffrey S. Handen, Ph.D., is a director in the Life Sciences practice at Grant Thornton LLP and a leader in R&D transformation. He has published in multiple peer-reviewed and business journals, presented at numerous industry conferences and scientific meetings as an invited speaker, and served as past editor in chief of the Industrialization of Drug Discovery and Re-inventing Clinical Development compendiums. Handen has more than 20 years of experience in pharmaceutical and biotechnology R&D, process re-engineering, and systems and process implementation. He is responsible for overseeing business process improvement and solution architecting for optimizing both clinical development and discovery. You can contact him at jeff.handen@us.gt.com.

Lisa Cooney is a director within the Life Sciences and Organizational Change Management practices at Grant Thornton LLP. She has significant experience leading global transformations in the pharmaceutical industry, particularly in R&D, regulatory, and manufacturing. She has more than 25 years of experience in process excellence, program leadership, change management, communications, and training. Cooney is known for helping individuals and companies navigate change successfully. She also serves on the board of directors for the Healthcare Businesswomen’s Association. For more information, contact her at lisa.cooney@us.gt.com.