A Singular Root Cause Undermines Clinical Trial Success: Leveraging Best Practice from 50 Years of Applied Research

McGowan,Brian;

A Singular Root Cause Undermines Clinical Trial Success: Leveraging Best Practice from 50 Years of Applied Research

February 6, 2023

Brian S. McGowan, PhD, FACEHP

Publication

Article

Applied Clinical TrialsApplied Clinical Trials-03-01-2023

Volume 32

Issue 3

Researchers face various challenges that cause their clinical trials to fail to meet enrollment timelines, among other issues.

In response to the complexity challenge, sponsors, chief resource officers (CROs), and sites are increasingly embracing any number of technical, operational, and tactical solutions to compress timelines and reduce costs while improving study performance (i.e., delays and deviations). These reactive solutions are becoming overwhelming (in both rate and volume)–creating mounting stress on the trial teams, sites, and staff. For example, two-thirds of site staff say that stress adversely affects their performance, 70% of site staff believe conducting clinical trials has become much more difficult over the last five years, the average current turnover rate for CRAs is 30%, following typical turnover for clinical support staff of 16%, and staffing is cited as the #1 challenge faced by sites.^3,4

And what is the result of these challenges? Evidence suggests that nearly four out of five clinical trials fail to meet enrollment timelines, half of sites fail to enroll even one patient, and nearly nine out of 10 clinical trials are delayed and/or stopped early because of poor performance.⁵

Given this one-two punch of the mounting complexity challenges and the burden created by reactive solutions, one might paint a dire picture of where we are headed, but I’d like to posit that there is an untapped potential to drastically change our course.

What if I told you that nearly all of the challenges that undermine clinical trial success are due–at least in part–to the same root cause? What if I told you that some really, really smart scientists have been working on the solution to this root cause for nearly 50 years? And, what if I told you that applying this fundamental solution to overcome the challenges of contemporary clinical trials will be surprisingly easy and incredibly rewarding?

The root cause

In reality, contemporary clinical trials, while increasingly complex, are actually just an exercise in change management. For trials to be successful, the stakeholders (sponsors, sites, and teams, etc.) need to change the way they think, behave, and perform in accordance with trial protocol and goals. And these types of change management exercises have emerged as one of the most productive fields of scientific advancement over the past half century. The evidence is robust and numerous Nobel prizes have been awarded to the pioneers in the field and the findings they have uncovered in settings as various as economics, finance, the military and healthcare. And this evidence illustrates what should be seen as a singular root cause for nearly all that ails our contemporary clinical trials. As a community, we continue to underestimate, underdesign, and under resource the requisite pillars of change management.

What are these pillars of effective change management? Mounting experimental and real world evidence suggests effective change requires individuals (and the teams in which they work) to do three things: Change what they know, change how they think, and change how they behave.

This is where the fundamental solution becomes both surprisingly easy and incredibly rewarding. Because of advances in learning science we have uncovered critical best practices in knowledge change. Because of advances in cognitive science we have a clear roadmap to support critical thinking. And because of advances in behavioral science we have definitive strategies to scaffold behavior change.

While an exhaustive exploration of learning, cognitive, and behavioral science is beyond the scope of this initial article, let's briefly highlight three of the most seminal lessons from each field.

Learning science has taught us that learning is rarely episodic, instead learning happens over time. We also know that learning is rarely passive, instead adult learners (i.e., investigators, site teams, patients, etc.) must be mindfully engaged and motivated to learn. We know that feeling familiar with content is often a barrier to truly mastering content. And, we know that the approaches to learning that learners perceive as being most effective, are often least effective.⁶

Cognitive science has taught us that the act of thinking is predominantly superficial and irrational, what has come to be known as ‘fast thinking.' For example, we know that adult humans (i.e., investigators, site teams, patients, etc.) are prone to natural short cuts and heuristics in thought that are often misleading and at times fundamentally wrong. We know that we overestimate both hindsight accuracy and forward-looking predictions. And, we know that we are at risk of falling prey to self-consistency biases that prevent change.⁷

Behavioral science has taught us that behavior change is ultimately the outcome of our motivation, our abilities, and the environment (system) in which the desired behavior takes place. If we are highly motivated, we can often change even if our abilities are lacking. If we have expert abilities, we can often change even if the environment is poorly designed for change. If the environment is well designed, we can often change even if we lack motivation. And, if we intentionally model and practice behavior change, almost any change is possible.^8,9

Despite all of the best practices that have been generated by learning, cognitive, and behavioral science, sponsors, CROs, and sites have tragically moved in just the opposite direction. Over the past 25 years, study start up processes have failed to evolve. As a strategy to lessen burden on trial teams, more than 90% of trials have minimized study training requirements. As a strategy to accelerate timelines, the majority of sponsors and CROs have reduced or eliminated the necessary planning and development required for successful training and performance change. As a strategy to reduce budget and simplify planning, less than 10% of trials include personnel with training or performance change expertise.

Each of these responses to the one-two punch of the mounting complexity challenges and the burden created by reactive solutions has in fact proven counterproductive and the resulting training and study start up experiences now deliver little-to-no value for sponsors, CROs, and sites; instead they demand more time, more energies, and more resources from the already overburdened teams.

The solution

In short, our community would benefit tremendously by embracing the realities of change management and each of its three scientific pillars.

Learning science affords us the opportunity to empower trial stakeholders to gain knowledge, competence, and confidence more efficiently. From PI meetings to site initiation visits to protocol amendments to informed consent–the success of contemporary clinical trials depends on how well we train and learn.

Cognitive science shows us how to structure critical decisions to ensure trial stakeholders choose more rationally. From protocol development to site selection to staffing allocations to patient identification–the success of contemporary clinical trials depends on how well we think, plan, and choose.

Behavioral science illustrates how to scaffold the right actions at the right times and to motivate trial stakeholders to act in accordance with the protocol. From study start up to patient recruitment to the provision of care to on-going compliance/adherence–the success of contemporary clinical trials depends on how well we perform.

In other words, by viewing each trial as a change management exercise; sponsors, CROs, and sites can establish a simplified, structured, and evidence-based approach to catalyze study start up, elevate trial performance, and ultimately, ensure trial success.

While each trial is unique, the lens of change management is a singular solution that ensures adequate and effective planning and support. By leveraging best practices from the three pillars of change management (learning, cognitive, and behavioral science), study start up takes less time, is more efficient, and can more effectively motivate and engage trial teams.

In the end, it’s my hope that this introductory article generated awareness for some readers, led some to contemplate a need for change, and drove some to take action–this is the journey of change!

Over the coming months our intention is to take a deeper dive into both the root cause and the solution through a series of articles and interviews exploring each of the scientific pillars of change management and to provide specific examples of how these best practices are being applied in practice.