PharmaVOICE Blog Post

Effective Virtual Site Training Is the First Step to Decentralized Trials

Posted By: Dan Limbach
December 21, 2020

There was a time, before 2020, when most of the clinical trial start-up and nearly all clinical trial training was done in person. Remember those days?

Unfortunately, that work also made up a huge budget line item – with the average price tag for big meetings (like a series of global investigator meetings) coming in close to $1 M USD.

Now, as the industry marches to a virtual future, there’s a lot of unspoken risk that Trial Sponsors and CROs alike will fail along the way. What’s the first step to avoiding that failure?

Start with the part of the trial that was designed for a virtual transition: all the site and staff and team trainings necessary to master the protocol, eSystems, and SOPs involved. Here’s how to do it – right.

Make all of your training attendance virtual – and flexible

Let’s talk about the PI meeting as an example. Did you know that up to 60% of Investigators may fail to attend a meeting? You probably did, and you probably try not to think about it.

If you also consider that there will be changes in staff over the duration of the study, you can see the rising potential for risks and missteps simply coming from key trial staff being uninformed. And yet – many clinical operations professionals simply accept this as the “standard.”

Because so many accept these things as unchangeable, the solution feels like it should be as simple as scheduling a web meeting to cover the eight hours you planned for the meeting, right?

Wrong.

Multiple brain studies have revealed that the average attention span of an adult is only 10 minutes. Imagine how often attendees will become distracted if they are not interested in the topics being shared or not actively engaged in some way.

How much do you enjoy sitting through eight hours of PowerPoint presentations, in-person or online? How much do you think your PI and CRA attendees enjoy it? And how much do you actually remember?

So why are we perpetuating a model that accepts this? There’s a better answer.

Don’t just shift your baseline content content to a web meeting. It’s time to transform how you approach these meetings in order to get the most out of them, and achieve the ultimate goal: preparing staff and teams to succeed in your clinical trial.

If you want to achieve that goal, you need to do three things:

  • Optimize your content for a virtual experience.
  • Make your meeting on-demand instead of live.
  • Plan to re-engage over the period of time after the PI meeting.

Optimizing your content for a virtual experience

We recently released an article on this exact topic – 7 Tips to Transform Training Content for Use in Virtual Clinical Trials. Whether the conduct of your trial will be decentralized, virtual, or not – anything you can deliver remotely can be reimagined with these tips.

The best part of building out your training this way is that you can begin to think about planning content based on what the attendees know already. Focus on the new learning as your outcomes for the training content, and you may find that you have less content to build.

Making your meeting on-demand instead of live

Whether you’re planning an in-person meeting, or a virtual one, we’ll always have the possibility that some, or most, of your staff will be unable to meet at a specific time. That likelihood grows the longer the meeting is.

Why would you choose a live web meeting when you can make it available to attendees on-demand?

Plus, many digital tools make tracking attendance and engagement for on-demand learning possible.

Re-engaging attendees over time

For most trials, the learning ends when the meeting does. It shouldn’t.

You can easily let your training concepts do double-duty. Plan a regular cadence of follow up emails, as I mentioned in the previous section.

It’s a best practice to reinforce the most important concepts you already put together for the initial content. Don’t create new content – you can just reuse what you produced for the meeting. Your desired objective is for key content to be remembered and retained.

And speaking of memory and retention, individual engagement is the second thing you must do for an effective virtual training.

Engage clinical trial staff individually

One of the biggest challenges with delivering an effective clinical trial training is that there are only a handful of presenters with mastery of the information.

But there’s a room full of attendees, who all learn at different paces, have different roles, and are interested in different parts of the content.

Imagine if you could virtually sit next to each PI, study coordinator, or staff member, and specifically call their attention to something you know is important? Stop them in their tracks to ensure they pay attention, or to give them resources they may want to refer to for more information?

Individuals learn in many different ways, and at their own pace. Some will want more information, and some will feel confident after the first presentation of your content.

Most on-demand virtual learning platforms today offer you the opportunity to deliver these learning moments. At any point in your content, you can call attention to an important point, ask each individual a question that they must answer, or provide additional resources and content to the learners who need more support. It’s truly individualized engagement.

A second major challenge is that there can be great swathes of time between when the PI meeting occurs and when investigators will sit in front of their first subjects. How much of the information presented at your PI meeting will be retained months later when it must be applied?

Incomplete or lost learning leads to problems like protocol deviations and early high screen failure rates. Many of these missteps could be prevented if you use the tip I shared earlier in this post to plan a regular cadence of the same critical study objectives you presented as refreshers over time.

Using this approach will allow you to make everyone aware of the most important FAQs, to drive the implementation of processes, and support your staff in becoming the most knowledgeable about your protocol that they can be.

But you can do so much more, like identify where an attendee is most at risk and then nudge them to dive deeper into those critical study objectives until they have mastered the topic.

Or even more useful – you can identify the members of the attendee population who are most well-prepared, and most likely to succeed right away with the trial protocol.

Look beyond pass/fail to clinical trial team readiness

Imagine this scenario: all of your PIs and CRAs attend and complete your required training meetings, whether in-person or virtually. At the end of the course, you present the entire group with a multiple-choice quiz that they must complete individually.

Some of the attendees might answer correctly and be completely sure about their answers. That group has gained the knowledge and is ready to apply what they have learned in trial.

Others, however, may get through the test by completely guessing. Perhaps all of these attendees manage to pass the quiz. Do you think they are all prepared to adhere to the protocol in the field?

It’s time for us to overhaul the way that we gauge how prepared our sites are to succeed in a clinical trial. There are many different ways to improve how we measure our investigators and sites, including:

  • Switching from multiple choice to a vignette that requires a clinical decision
  • Using confidence-based assessment in addition to a right/wrong answer
  • Assessing attendees’ aptitude or willingness to implement the new things you presented

You want your trial to start with the sites most likely to hit enrollment targets. So why are you guessing at who those are? Incorporating these types of changes will improve your trial performance.

That’s because looking beyond a simple pass/fail model also opens up your ability to provide a measurement that proves to sponsors and contract research organizations (CROs) how well the material has been understood, where the attendees’ strengths and weaknesses lie, and how well prepared the attendees are for participation in the study.

Trial managers can make faster and more informed decisions based on actual data that reveals which PIs and trial coordinators understand the protocol and enrollment requirements. Combine your usual site data with clear evidence like these 3 metrics for your site selection checklist and you’ll find the best possible sites to start and conduct your trial.

Getting started with virtual clinical trial training

Need more help on moving your trial training to a virtual experience? You’re in good company: more than ¾ of the industry is planning to do the same.

So be sure to check out the links I included in this article for more information. Need even more? Download this recent report on the impact of virtual tech on clinical operations.

Posted in: Clinical Trials, R&D

About the Blog Poster: Dan Limbach

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