Author: ArcheMedX Team

The decentralized clinical trial is one of the most talked-about emerging trends in the life sciences industry. These sorts of clinical trials present immense benefits, as we wrote about in a recent blog.

If executed well, the decentralized clinical trial design could both reduce resource consumption and accelerate treatments arrival to the patients that need them.

But to realize the benefits of a decentralized trial, it’s important to understand that decentralization means education at scale. It means training at scale. Because obstacles like patient treatment adherence, consistency of performance, and data collection loom large, it means you have to find a way to educate and train, assess, and then probably re-train in a way that doesn’t stretch your resources.

And it’s realistic today – if you can implement a few key changes. 

Decentralization means a focus on results, not just training.

In the traditional clinical trial design, you have the ability to look at very discrete activities that can be tracked and completed. Each investigator or site can become a milestone on the big-picture plan.

But in a decentralized clinical trial, you lose some of the core group dynamics that come from the reliance on centralized study locations. You could be working with people in faraway regions who are much less experienced than you in clinical research. Or you may encounter healthcare practitioners with only a single patient. Or – you may be engaging with mobile nursing or care teams.

Traditional clinical trial site training was created for a scenario where people are face to face with an instructor, and perhaps have one another to lean on afterwards.

As we decentralize clinical operations, we have to shift away from the idea of “completing the training task” and shift into the concept of “driving results.”

And in case “results” feels too obtuse, let’s get specific. Start thinking about how you equip your trial team to:

• Meet your overall enrollment targets. Where a centralized clinical trial site may have had specific site targets, a decentralized trial design doesn’t mean that.
• Avoid deviations. Decentralization opens the opportunity to participate in a clinical trial to many more patients (and their caregivers) who may not have a lot of exposure to the process.
• Deliver the data and results effectively. There are going to be questions, and lots of retraining. If you accept that, and plan to make and maintain clinical trial readiness as a goal for your trial team members, you will reduce the effort on your part – and on caregivers’ parts.

A decentralized clinical trial demands quality control. Don’t make that more work – it should be less. 

Excited to spend days turning your protocol document into a 200 site initiation presentation? No?

Good, because that’s wasted time. When thinking about a decentralized clinical trial, you need to ensure quality and consistency. Your goal should be to see how much you can reuse to reduce your workload.

There is no good reason to convert everything to a slide deck, when learning platforms like Ready by ArcheMedX make more effective training directly on the protocol possible.

Focus on the content you’ve already gotten approved. Then spend a fraction of that time you were planning to invest in converting that slide deck into a far more useful exercise. Instead, use a platform like Ready to create learning moments and resources that focus each learner’s attention on the key points that need emphasis.

You’ve saved dozens of hours on slide creation, so use it to build content that emphasizes critical protocol points.

Protocols are rarely optimized for use by trial site staff, doctors, or personnel. This can become even more critical in a decentralized clinical trial. So think critically about where a set of new eyes might miss a point. 

Where could a caregiver need more detail or more scientific background? At what points could you add some additional materials to better support the protocol? Where are trial staff making notes, asking questions, or providing key pieces of implementation feedback?

Some things we’ve seen work well in other clinical trials:

Videos presented by research or development team.

Video is also extremely powerful for keeping someone engaged. Today, you can quickly produce a video using a variety of tools. For example,  your medical director could record a 90 second talk using their iPhone on the importance of the study. Or use a personal Zoom meeting to combine a site training powerpoint, with voiceover, or even music to break up the viewing experience. 

Infographics and visual ways to present past phase results.

Charts, graphs, flowcharts, and simple images are all effective to engage people visually with concepts you’ve included already in written copy, and they can all be created by anyone with a computer and the Internet. 

The great thing about engaging people is that they’re more likely to retain the information you’re putting in front of them. A video or well-designed image will engrain a point into the staff member’s memory. 

Embedded quizzes or prompts to nudge participants at key points in the protocol.

It’s a common best practice to use real world scenarios or vignettes to drive critical thinking during learning activities. This also helps break up the learning experience.

If you’ve delivered a case study in a large group at an investigator meeting, you can easily transition that to digital exercise. Virtually, individuals must complete the activity, rather than sit as you walk through the entire story with limited interaction. Completing the activity themselves helps to attach meaning to the content you’ve provided them. That meaning is what prompts the recall of the concept in the field.

Make your vignettes complex, and make them as realistic as possible. And make them take a decision while thinking critically. Remember that you are equipping people that will have to deal with real patients and real risks during a clinical trial, and they may be without experienced clinical staff that would exist in a larger study center.

Distributed clinical teams need ongoing training and support. Plan for that.

We’ve mentioned the Forgetting Curve in previous posts. It’s well-documented that humans will forget 70% of what they learned in 24 hours. We retain information better when it’s repeated.

So it’s important to build a cadence of communication to re-emphasize points that need to be retained or remembered. But a cadence like this can help you in other ways.

There’s a trend of CRAs or trial managers sending out “newsletters” hoping to deliver best practices or updates. These can quickly become noise – and worse, vary in quality and accuracy.

In a decentralized clinical trial, there are many more people to remind, engage, and update. Establish a schedule, and centralize the execution for your dispersed personnel.

Our clients tell us that they use Ready to develop regular, ongoing communication streams with our Boosts feature. During a trial, these clients use the automated Boosts to deliver best practices that they discover from caregivers, updates to processes, and even amendments to the protocol. 

Embrace technologies that support asynchronous delivery and decentralized teams.

In losing the centralized study training models, you also avoid the struggles of coordinating calendars and travel with very busy people. Embrace the flexibility of asynchronous learning, that is – delivering your clinical trial content on-demand.

Decentralized teams may span geographies and time zones, and you could easily spend days or weeks trying to deliver various sessions to accommodate all. Instead, choose technology that lets you deploy once, and update centrally.

Asynchronous learning isn’t the same as a recorded video, that can fail to engage or deliver any measurable results. In fact, the opposite can be true.

We blog frequently about clinical trial readiness, and a large part of readiness is the ability to measure. That is, understanding how capable and confident personnel are with applying your content.

As we described previously, metrics are both available and important for clinical trial readiness, especially in a remote clinical trial.

For example, imagine your entire clinical trial team completes an online presentation covering your upcoming trial protocol. Do you present them with a quiz to test their recall of critical information?

If you do, some of the team might answer correctly because they have gained the knowledge and are ready to apply what they have learned in your trial. Others, however, may get through the test by guessing. Perhaps they all pass. 

If they do, are they all equally prepared to conduct your study or are you releasing under-prepared staff, patients, and caregivers into the field alongside others who are ready to make good decisions. Without measuring readiness, which is what we drive towards with Ready, you won’t know how risky this is until you run into trial delays and deviations, or worse. 

Ready by ArcheMedX makes decentralized clinical trial training scalable. 

There are still a lot of challenges for life science companies that want to deliver a decentralized clinical trial. Fortunately, there are some strategies that will deliver benefits to any clinical trial – and developing a scalable approach to educating clinical trial teams is one major opportunity.

The first thing you need is an approach, and clinical trial readiness is an ideal one. Learn more in the Definitive Guide to Clinical Trial Readiness.

Second, you need an on-demand delivery platform for learning at scale, and Ready by ArcheMedX is the only learning and insights platform designed to better equip clinical trial teams. Ready is an ideal tool as you work to adopt the decentralized clinical trial design, and you can get a demo today.

There are still a lot of challenges facing pharmaceuticals, med tech, and biotech companies that seek to begin a clinical trial post-COVID. But the obstacles aren’t stopping them. At time of writing, over 500 companies have a Phase II or Phase III clinical trial startup planned in the next 12 months. Clinical research moves on, as it must.

If you’re planning a clinical trial, you already recognize some major differences from past studies. And the emergence of new trial designs like decentralized clinical trials and hybrid trials provide new opportunities – and obstacles of their own. 

However, regardless of your clinical trial design, there are three major differences every clinical operations leader needs to expect. Here’s a discussion of each one – along with some ideas of how to tackle them.

First, remember that it’s anything but “business as usual” for your clinical trial sites.

You feel the challenges of the ongoing pandemic, don’t you? Remember that many of the site staff are frontline healthcare workers. Their challenging day jobs are exacerbated by everything you’re feeling.

And you may worry about loading up already stretched site staff. There’s a lot they have to do before they even enroll the first patient: study startup training, initiation, and activation activities.

But with the availability of new digital and remote enabled tools, you can actually use the clinical trial startup to reduce site burden.

Reduce site burden by accommodating their busy schedules.

No, I don’t mean running web meetings every hour on the hour. Instead, think asynchronously. That is – make your protocol and clinical trial content available on-demand, instead of on your schedule.

On-demand start-up activities, such as site training, ease the load of the all-day meeting for site staff.  It also accelerates enrollment, because staff can begin preparing to screen patients as soon as your on-demand training is available. No more waiting for schedules to align for a group meeting or visit.

Using more advanced tools (like Ready) to deliver interactive training also enables you to collect valuable data immediately.  This data can then inform faster operational decisions (i.e., prioritizing site activation and monitoring coverage) based on real-time insights into site and staff readiness.  One of our largest clients, PRA Health Sciences values this quick access to data and actionable insights.

In fact, in equipping their own CRAs, PRA’s leadership uses Ready to deploy more interactive content globally. They can quickly determine which of their CRA team members are ready for a specific trial, and which ones need more preparation. This lets them intervene early to increase the capabilities of their teams where needed. You can do the same with site staff, or even your CRO’s team members.

Reduce site burden by consolidating their clinical study startup resources in a single hub, available anytime.

When you provide site training and activities in an on-demand environment, you get to avoid sending multiple files, portals, or emails stuffed with attachments. 

Centralize your study startup content into a single portal, or learning experience. And cut the extraneous noise of extra emails.

Tools like Ready make it so easy for you to build your site training around your existing protocol and essential study documents. Instead of wasting time converting each document into a slide deck, and then trying to deliver individual training sessions for each site, a far more useful exercise is to utilize a platform like Ready to turn that essential document into an on-demand and highly engaging learning experience.

Best of all you can do this in hours, not days and weeks. This saves valuable time (and possibly many hours of billable CRO time), and helps to drive consistency in your content. As we suggested in a recent article, you can re-invest some of the saved time by pulling together complementary resources, or improving your assessments.

And packaging all of your resources into a focused learning experience makes it easy for you to update, enhance, and deploy the same quality of learning to everyone even if they join a site part-way through a trial. Even better, it simplifies the lives of your site staff. It helps them to know where to go for everything related to your protocol, SOPs, and best practices.

Second, the reasons you had for using the same sites for every study startup are not as compelling now.

There’s really no good reason to only stick with “tried and true” sites post-pandemic. In a recent interview with Liz Beatty, the Chief Strategy Officer of Inato, she revealed that 70% of clinical trials are performed by the same 5% of trial sites.

And is there a great reason for that? Despite the belief that tried and true sites should be reliable to enroll and perform, there has been no marked improvement in the performance of clinical trial sites over recent history. In fact, Tufts reported that the clinical period has gotten longer.

It’s an ideal time to disrupt your model for activating sites for two major reasons.

Getting onsite is difficult today, so location isn’t as critical.

While it’s difficult to get onsite today, it is, and has always been, a burden to your sites when you’re there. In the push to reduce site burden, now is the time to reduce your reliance on in-person visits. Without that barrier, your site options expand greatly.

Is it now possible for you to consider sites that may be in regions that offer more diversity? Or perhaps areas with a less experienced but highly motivated investigator who has an available patient population…but hasn’t worked with you before?

The opportunity to expand to new sites and untapped patient populations has never been greater. Plus, over the past two years it has become evident that not only is diversity in your patient demographics needed, but it will be expected. Investors, partners, regulators, and the entire industry are expecting clinical trial leaders to learn and to change how they research treatments across ethnicities, cultures, lifestyles, and ages.

There are ways for you to objectively measure site readiness early in the clinical trial startup.

A site’s experience with you, your CRO, or any past clinical trial doesn’t tell the full story about its ability to perform in your upcoming trial. Site staff change, patient populations shift, sites may be enrolling competing studies. Solutions like Ready can reveal the critical insights you need to know about a site and its staff capabilities as they currently exist.

• Want to see their confidence in enrolling the right patients quickly? Easily done.
• Need to understand staff knowledge around handling and administering your investigational product? A snap.
• Think it’s important to assess a site’s understanding of decision-making on exclusion criteria? Yep, that’s easy, too.

With objective and immediate readiness analysis available across all sites, both new and old, there is no need to guess about which sites can perform. You can have the same level of confidence whether you’ve worked with a site a dozen times, or never before. And – likely slash the risk of missing enrollment targets.

Third, the big in-person investigator meeting is not only off the table, it may be gone for good. 

OK, it’s probably not gone for every clinical trial for good. But depending on your specific objectives, you may not need it. And if that’s the case, you’ll greatly reduce your costs and workload. Plus, you’ll avoid the burden of scheduling a lot of very busy people away for hours or even days more than necessary.

One emerging biotech we work with has reimagined the PI meeting completely. This biotech instead chose to use Ready to deploy all of their PI meeting content completely online and completely on-demand. That means, similar to site training, investigators and study coordinators can begin consuming the protocol as soon as it’s deployed by the biotech. And that means the trial team can immediately discover insights about investigator readiness, too.

Just as you adjust your clinical trial startup, your trial team will adjust, too.

Fortunately, we humans are natural innovators, and natural adapters. You’ve already had to make major changes, and your sites, teams, and patients are making changes too, too. 

But when you’re not there in-person with your clinical trial resources, it’s easy to lose sight of the opportunities you have to help them adjust to your changes. 

Take the ongoing uncertainty in our environment as an opportunity to change. Don’t just do it for your next trial, but establish new and better processes to pave a path for running higher performing trials. For reducing your risk and error. And for embracing a future where you may run a truly decentralized clinical trial, or even a fully virtual trial. 

New digital tools and predictive models will make this shift much easier, and can also deliver benefits to the rest of your team. But you must recognize these three challenges, and plan for them. Ready by ArcheMedX can help you improve your clinical trial startup, while you simultaneously improve your site and team performance (and ease their workload, too).