Better Site Training - Learning from the Pandemic

Posted by Paddy Wall on Sep 9, 2020 11:40:33 AM

The Investigator Meeting and site initiation visit (SIV) are two critical milestones that mark the beginning of a clinical trial for many members of the site team.

Traditionally, Investigator Meetings involve the Principal Investigator and Study Coordinator travelling to large conference venues or hotels to view multiple presentations over the course of two days. Often the Investigator Meeting falls well in advance of the site being ready to enroll a patient, which means that while these meetings are excellent networking and learning opportunities, a lot of the learnings may be rusty by the time the site initiates. The SIV follows, weeks or months later, when the CRA arrives at the site armed with a PowerPoint deck of more than 200 slides and the best of intentions. The vast amounts of information in that deck must be disseminated throughout the site team. This challenging process is replicated by different CRAs across site teams in other regions, countries, and far-flung time zones.

There are good reasons why PowerPoint is the most prevalent form of presenting information. It’s easy to use, shareable, cost-effective, and used properly can be very effective. It is good for well-structured concise presentations of less than 10 minutes. However, once a presentation goes beyond ten minutes, even the best speakers with the most willing audiences will start to lose impact. Business leaders like Jeff Bezos and Jack Dorsey have recognized this and, for their management meetings, insist on a more narrative based approach.

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This is a challenge even when delivering the presentation in person. It becomes a massive mountain to climb when the person is presenting remotely, which is often the case in the current situation of the COVID-19 pandemic. SIVs, in particular, do not lend themselves well to the PowerPoint approach, because these meetings are lengthy and involve vast amounts of information.

Additionally, the presentation of an identical PowerPoint deck can vary widely from presenter to presenter and meeting to meeting, potentially introducing misunderstanding and error before the study has even begun. Any and every CRA might present the material perfectly, and attendees may absorb all the information completely, but such consistency is not likely.


Ensuring the Remote Investigator Meeting/SIV Meeting is Productive and Useful

Today in our socially-distanced world, the very idea of travelling to a meeting, eating finger food, and chatting at distances closer than two meters seems like the height of risk and is unlikely to be the norm for some time. Despite this, we still need to achieve our goal and ensure that sites are well prepared and well educated in advance of enrolling patients in our clinical trials. When you can’t gather staff in person for a meeting, when you can’t observe their engagement, you know less than ever about how much they have learned and how likely they will be to retain it. In this remote world, communicating in a boring or disorganized manner can be disastrous.

If we want to maintain an audience’s attention for more than 10 minutes, we need to look at an alternative approach. The secret is to introduce variety and break up the training formats for the different SIV agenda items. For example, animated video is well-recognized as an impactful format and is very well suited to conveying study designs, disease overview, and IP mechanisms of action. Other sections may be better suited to simply reading and acknowledging a document similar to the narrative approach outlined above (e.g., a discussion around recruitment strategy). And yes, sometimes, a concise and well-delivered PowerPoint will be very effective (e.g., a study introduction from your respected KOL).

An added benefit of utilizing different training formats for different items means that you can deploy a lot of this information online through your site study portal for attendees to complete/view beforehand, allowing you to shorten the online meeting to a more practical and audience-friendly duration.

Since most informational meetings must be conducted right now in a work-from-home context, relying on a blend of video and other appropriate formats is a more productive way to disseminate information.

Using your site study portal to get information out to sites at the trial outset (as well as through the entire duration of study conduct) provides additional benefits. Deploying and tracking material through a validated 21 CFR Part 11 environment supports your inspection readiness, analytics allow you to assess engagement, and any presentations can be recorded and deployed as training modules for site staff who join the site team later in the study.

At Longboat, we offer the solution that provides all these benefits, reduces variability from presentation content, and provides sponsors with the ability to know for sure how well site staff understand critical content and how prepared they are to operate a successful clinical trial.

As an added bonus, if you choose us over that 200-slide PowerPoint deck, you’ll probably also collect some thanks and kudos from everyone on the receiving end!

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Topics: eLearning, Clinical Reseach, Clinical Trials, COVID-19

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