Are You a Laggard in Clinical Research?

Written by Nicole M. Palmer and Edye Edens

In a world of innovative and life-saving therapies, where we constantly push scientific and biomedical boundaries, how is our industry still full of late adopters?

As a research compliance expert, this is one of the most frustrating elements of the clinical trial industry.  We surround ourselves in an expansive data economy, collecting more data points on each and every trial than we even have a purpose for, but when it comes time to make some of the most critical decisions on how we conduct, oversee, and operate our research… you guessed it, crickets.  Suddenly we act as if we have no idea how to perform market research, connect to end users, stay patient-centric, retain engaged employees, implement quality assurance, and compliance is merely a window dressing.

What is the motivation behind this late adoption model that has major organizations making poor decisions on everything from technology to talent to trial feasibility?  I’d like to explore how we make some of these critical decisions in our clinical trial ops without utilizing what we do best – collect and analyze loads of data!

First, I’d like to posit the path to leadership is broken.  Many of you have heard my spiel on the ‘healthcare package deal’ whereby we assign leadership roles based on clinical prowess in healthcare-facing organizations and undervalue the actual ability of the individual to LEAD.  Data is the answer to this and frankly every question I’m going to ask you.  If a leader hasn’t surveyed the landscape for which they are making a decision thoroughly, utilizing facts, data, and stakeholder input evenly, they aren’t doing their job.

Second, leaders are still human.  And as humans, especially determined, driven, and highly regarded as intelligent humans… we have no clue what to do when we don’t know the answer or aren’t the SME in the room.  It’s no different than the fear I see in my four-year-old’s eyes when he looks to me for validation before trying something new.  All the more reason to rely on data, ‘cause data don’t lie and it isn’t full of fear or any other emotion. 

Third, are we asking enough questions?  Are we asking the RIGHT questions?  The number of times I’ve been told by senior leadership in the last two decades that an issue we had in ops – be it retention, compliance, culture, you name it – was factually unable to be remedied and we needed to acquiesce… only to request the data to show this fact and be told there was no data.  That’s absurd.  We ask our patients to fill out surveys, take investigational drugs, tell us their worst health crisis moments, and let us see them nude, poke and prod, but we can’t ask our employees why something isn’t working.  Come. On.

Fourth, and I will make this finally, it’s a matter of culture at the end of the day.  If you have an organization devoted to excellence and committed to collaboration in the name of bada$$ clinical trial work for all our patients in need, blame won’t be a part of their culture.  Asking questions, collecting data, being honest about weaknesses, and seeing the CEO in the hallway talking entry-level level staff to learn more about their day-to-day needs ~ this will be the hallmarks.

Nicole, what do you think?

When I think of “adopters” it’s how people consume an idea, system, or process. There are different levels of adopters. You have your early adopters. The ones who are willing to take a risk and try something new. They’ve done their homework and want to be one of the first to try the product/system/process.

Then you have the majority of adopters. The ones who wait and see. They are evaluating the risk-to-benefit ratio. Is this the best ROI?

Then you have the late adopters or the laggards.

I can remember growing up as a child, we were always the last ones, or it seemed that way to have something new. I can remember all my friends at school had a microwave. I was so jealous of them. I would ask my parents when we could have a microwave. And they never entertained the idea for a long time. Years to be exact. When I think of my parents now, they don’t even have a computer or internet. True story! Talk about laggards. Will they ever get internet? I have no idea.

The late adopters have to see the value. The price has to be right. They are resistant to change. They are the ones that say, ‘this is how we do it and we’ve always done it this way.’

I can remember the first time, I presented the idea to my boss, who was the CEO, we needed an eTMF. At the time, we had a paper TMF. I had to talk up the benefits and why we needed one.

 Were we the only ones in clinical research still using a paper TMF? No. It was still common at the time. The key is being proactive.

I got in touch with several eTMF vendors, scheduled lots of demos, and invited all the key stakeholders. Everyone was excited to see the demos. We weighed out all the pros and cons. The key stakeholders saw the value. This is important.

What’s also important, is once you’ve got your team motivated, how are you going to keep them motivated when it comes time for onboarding and training?

1. Communicate the benefits such as increased efficiency, and improved data quality, and you will be in compliance.

2. Get your stakeholders involved in the process- This helps ensure that the new process will be tailored to their needs and that they feel invested in the success of their TMF.

3. Provide training and ongoing support- This will help the stakeholders make sure they understand the new TMF process, and it will help them feel confident in their abilities to implement it.

4. Be prepared to address any concerns that the stakeholders may have. Listen to the feedback or any concerns they have and address them.

5. Lastly, don’t forget to communicate once the new process is implemented, the successes along the way. Talking about the success can help build support and momentum so that the new process continues to be implemented.

By being proactive you can be prepared. Luckily, we were prepared when Covid hit. We had been using an eTMF system for a couple of years. Had we not converted, we wouldn’t been able to work remotely as efficiently and our TMF would have suffered.

Regarding, clinical research as a whole. We are lacking. I agree with you Edye. Something needs to be done. Often, we are late adopters, and we shouldn’t be. We didn’t get into clinical research to be late adopters. We are here and we have one goal. And that is to provide top-notch quality work in everything we do. We are all trainable. Often more times than not, the process or the system is broken.

It’s important to be proactive instead of reactive. Reactivity leads to tension and poor morale. It decreases the comradery on your team. Instead of pointing fingers at people, which never works by the way, let’s examine the process and see where the gap is because we are all trainable. And the reality is, there’s a gap in the process. We can fix that.

It’s so simple yet complex. Do you have a plan? What’s the plan? What are the risks? When are you going to implement it? How often are you going to monitor and evaluate? Who’s going to do what and how is it going to be communicated? It’s a process. A continual process. Snail speed is unacceptable. Here’s why.

Patients are waiting. They aren’t just a series of numbers. They are real people. Sometimes, participating in a clinical research trial is their last bit of hope. They are praying or hoping for positive vibes to come their way that this treatment will help them live a little bit longer or cure them. They are sick. Their loved ones are under a tremendous amount of stress. Handing them a 20-plus ICF to take home and read is not helpful. It’s cumbersome. Perhaps it takes them too long to get through the ICF and it’s too late. Trying to research the PI and do your due diligence as a patient to see if you are getting the best doctor for your therapeutic area can be exhausting when you are already weak.

We know our weaknesses in clinical research. It’s time for a change. I don’t know about you Edye, but I can’t just sit back and be a late adopter when it comes to patients. Let’s be the change.

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