Three Key Considerations for Risk-Based Training
When you think about taking a risk-based approach to clinical trial training, what does that mean? A risk-based approach ensures the quality of a clinical trial by identifying, assessing, monitoring and mitigating risks that could affect the quality or safety of a study. We use training to mitigate identifiable risks and decrease protocol deviations.
Using what you know about potential risks and sharing that information with your sites is the foundation of a solid risk-based approach. That’s why effective training is such an important tool to help you anticipate and circumvent the risks.
There are three things you need to know to help you develop and deliver training that will help you mitigate study risks with an effective risk-based approach.
1. Captivate your audience.
One of the best ways to deliver great content is to make it relevant to your audience. Focus on concise messages covering potential study challenges. Don’t let the most important things you want your sites to remember get lost in repetition of common sense content. Instead, cut to the chase with the most critical messages. Skip self-explanatory points and focus on the complex and more challenging parts of the protocol.
Great training content should be an opportunity to provide information and knowledge checks, verify that trainees can apply the knowledge in real-life situations and take the appropriate actions when things go wrong. For example, create training that mimics a patient’s journey by participating in the study, starting with being included as a participant, completing the screening and randomization process, and reviewing the essential visit procedures and safety concerns.
Then, challenge the learners to think about what they would do if things went awry. For example, use live-action video to demonstrate how to administer a test, inject the investigational product or complete a particular patient assessment. Seeing a demonstration is much more powerful than listening to someone review PowerPoint slides.
2. Make your delivery count.
Another vital element of emphasizing a risk-based approach in your study training is how your training is delivered. Whether it’s a face-to-face investigator meeting, a site initiation visit during a live or prerecorded web meeting, or exclusively on-demand, the key to successful training is to make sure everyone receives the same level of training. That is why it’s important to develop concise training content, using real-life examples that are effective in different delivery formats.
It’s also important to have training content available on-demand for participants to reference throughout their participation in the study. It’s hard to remember every detail of training that occurred two months before seeing a patient. By hosting concise content on-demand, sites can go back and quickly reference the training materials right before seeing a patient. And depending on the platform, they could pull up study-specific reference tools on a tablet or mobile device right in the room.
Training should be engaging and interactive. Turn on your webcam to make your training more impactful. Virtual engagement is the new world we live in, and human-to-human interaction matters. Even if it’s through a computer screen, seeing the presenter increases the audience’s attention by 45 percent. And asking trainees to share their webcam, too, increases their attention span and their ability to pay attention by 75 percent. If you turn your web cam on, most likely your trainees will, too.
Finally, up your innovation game. With innovation, a little will go a long way. PowerPoint training slides still account for more than half of the training content developed and delivered for clinical trials. But now, study teams are starting to realize that being innovative can actually increase retention. Creating an interactive module and requiring the trainee to think through different scenarios to determine the correct answers can be a powerful learning method.
3. Engage, engage, engage.
The last thing to consider for a risk-based training approach is how to keep learners engaged after their initial training is completed and they have checked the box on their compliance list. You need to create a forward-thinking plan to keep learners involved and their knowledge of the protocol up to date.
One way to keep sites engaged is to provide virtual Q&A sessions that re-emphasize ways to avoid protocol deviations. Schedule regular sessions once a month or maybe on an as-needed basis when a protocol amendment needs to be rolled out. Make them short and productive so it’s worth the trainees’ time to attend. If an amendment is covered during the Q&A session, remember to record the content and host it in an on-demand platform for those who were unable to attend the live session.
Use quick guides for things like inclusion and exclusion criteria and photonumeric rater scales. Consider using a visual pocket guide that the coordinator or investigator can pull up while with patients. Take something complicated with several steps and turn it into a quick guide that can be referenced when needed.
By focusing the training content on the key identified risks of the protocol and delivering concise and mindful training content, you will minimize the burden of required training. Help your trainees work smarter, not harder.
Amanda Steenbergen is WCG’s Senior Director of Global Clinical Training. In her role, she serves as a liaison between clients and internal teams working to establish best practices for clinical trial training, including developing training content in collaboration with sponsors and research industry key opinion leaders.