4 Tips on Implementing Change in Clinical Research

Clinical Researcher—June 2020 (Volume 34, Issue 6)


Christine Senn, PhD, FACRP


Everyone realizes how brilliant or necessary the new plan is. It’s a no-brainer. You’ll tell people what to do, and they’ll do it. That’s their job, after all. …

I don’t know about you, but there are probably 30 activities that are good for me that I don’t do. Cold plunges. Hot saunas. Green, leafy vegetables. Fatty fish. Meditation. High-intensity interval training. Wim Hoff breathing. (It’s a thing.) The list goes on.

The moment you remember that absolutely no one—yourself included—changes a behavior because they “should” change it, the better place you’ll be in to actually help people change.

In psychology, we do this through “motivational interviewing”—a method for talking to someone to determine every way in which he or she has ambivalence about making a change. By “interviewing” them about both practical and emotional obstacles they have to an idea, the therapist can help the person find ways to overcome those obstacles or think about the change in a new way.

I know bells are going off right now as you realize that everyone has ambivalence about change—even change that sounds positive. Name any singular thing that you, your best friend, your kid, or your partner is not doing that they “should” be doing, and you can probably guess at least one obstacle or objection standing in the way of them making that change. The goal I see in business is to predict the most likely obstacles and objections to a new behavior and preemptively remove or diminish them.

Taking the Angst Out of Change

If you haven’t read James Clear’s book Atomic Habits, do yourself a favor, because it’s superb. He describes four ways of fostering behavioral change: make the new behavior obvious; make it attractive; make it easy; make it satisfying.

Let’s take the example of decreasing consenting errors. A site research director has updated the procedure for documenting consent.

Make it Obvious

Rather than simply sending out the new procedure to staff, the director could also post a one-page version of the step-by-step procedure on the wall of every research staff member, or laminate the sheet and ensure every clipboard used to hold paper consent forms has the laminated procedure clipped to it.

Make it Attractive

Since quality assurance (especially in consenting) is so important to the U.S. Food and Drug Administration (FDA) and other regulators, and for patient safety, it may be worth rewarding staff for consenting well. For example, each perfect consent form completed could be worth an entry into a monthly drawing for a nice lunch. The director could also track the number of consent forms with no errors and, at 50 consecutive error-free forms, the staff member receives a monetary reward.

Make it Easy

After sending out the procedure, the director could conduct a short training on the new process. Consistent with motivational interviewing, it is this hands-on training that allows the director (if her or she actively solicits this feedback) to hear any obstacles or objections to the new plan.

Let’s say the new process requires the director to review the consent form before the patient begins the screening process. A very likely obstacle to this process is that the director is often unavailable due to meetings, and so could choose to train several people to do the review in his or her absence, thus making the process easier to follow.

In contrast, there could be an objection that a coordinator or investigator doesn’t believe they need anyone to check behind them. Objections are usually best handled by discussing the “why.” In this case, the director could reassure her staff that she thinks everyone is highly capable but that the FDA regulations and inspections by its Biologics Monitoring Program (BIMO) are highly focused on proper consenting, so this plan is entirely about keeping the research site, the investigators, and of course the patients, safe.

Make it Satisfying

A key to a new behavior being satisfying is having the reward follow the behavior as quickly as possible. Think of smoking: The dopamine jolt immediate follows the first inhale, so quitting smoking is difficult partly because finding a substitute behavior that is as immediately rewarding is difficult. In this way, waiting a month to receive an incentive does not meet this criterion. Instead, the director could plan immediate rewards for the first three months of the program, such as daily or weekly drawings for a smaller prize, or frequent public recognition of quality consent forms.

But Wait, There’s More…

Bonus time! This one example highlights tactics in behavioral change but skipped my absolute favorite tip: habit stacking. You want this one in your toolbox, so stick with me a little longer.

BJ Fogg introduced habit stacking in his book Tiny Habits. It simply involves adding a new behavior to an existing behavior.

Let’s say you want to start doing 10 pushups or 10 minutes of meditation each day. You’re also a coffee drinker and brew a fresh pot every morning. Starting tomorrow, as soon as you press the brew button on the coffee maker, you then do your new behavior (pushups or meditating). As soon as the coffee finishes brewing, you have completed the new behavior, and it will soon become a habit because you have made it easy and removed obstacles. It will soon become satisfying, as well, as you start feeling physically or emotionally stronger.

Habit stacking in clinical research is just as easy. Perhaps the site director wants to have patients complete a satisfaction survey after the randomization visit. He or she can follow all four ideas above: make it obvious by having surveys pre-printed and on display in every exam room; make it attractive by letting staff know that positive feedback could be posted on the site’s webpage; and make it satisfying by helping staff view this as a way to see how they make an impact on others.

As a tactic, habit stacking is usually seen in the “make it easy” step. In this example, how will the staff remember to give the survey to a patient at this very specific and very busy visit? I’d recommend either adding the survey into the source document checklist for every randomization visit or adding the survey into the checkout process for the randomization visit. It is the site’s software and existing processes that will determine where to stack this new behavior, but paper source documents, electronic source documents, and clinical trial management software can all be mechanisms for stacking a new behavior (task) into an existing process.


What I always remember when implementing a new task, new software, or new process is this: Everyone wants to do well. Particularly in our field, people actively want to do the right thing. Our industry and processes are so complex that it can become overwhelming for anyone. The behavioral tactics described here are intended to help you help your people be the successes you want them to be—and that they themselves want to be.

Christine Senn headshot

Christine Senn, PhD, FACRP, is Chief Implementation and Operations Officer at IACT Health, a multi-location research site network, and part of the hyperCORE International consortium of sites.