Site Training for Clinical Trial Success
Why site training is a key component of for clinical trial success.
You may know the price of site training, but what about the actual cost to your clinical trial?
Training site staff on the specifics of conducting a clinical trial takes time and money. But do you fully appreciate the cost and impact of inadequately trained staff to your clinical trial?
We’ve all experienced poor training: overly long sessions; pages of dense content or legalese with little or no learning impact; poorly designed e-Learning which is difficult to navigate, or the dreaded “death by PowerPoint” meetings. When we are not engaged, training is little more than a box-ticking exercise – it is possible to be technically trained without having achieved the learning objective.
In contrast, effective training using rich and varied content, leveraging highly engaging methodology will provide a positive user experience. Learners should feel confident in their understanding of the topic and this comprehension should be assessed and reinforced with an appropriate level of knowledge checks. The learner should walk away remembering key points and retain this knowledge long after the training session is completed.
Why is site training so important?
The clinical trial industry is a highly regulated environment with a primary focus on compliance to protocol and clinical standards, with the goal of delivering the highest quality data and protecting patient safety. Ensuring site staff receive adequate training, and that this is tracked on an ongoing basis throughout the clinical trial, is not only advisable but essential. It is also important that the tracking and reporting of training is transparent for audit purposes.
Failure to address this critical aspect could have impact of time, quality, and cost of your clinical trial.
- Lack of understanding in the details of the protocol - leading to misinterpretation of visit requirements with potential patient safety issues.
- According to Tufts protocols now have more endpoints than ever, according with the mean number of eligibility criteria across clinical trials in 2023 at 32.2.
- Deviations from the protocol could occur - leading to non-compliant data
- Errors in trial conduct could risk approval and could de-rail your clinical development programme.
- Lack of awareness of details in inclusion and exclusion criteria - resulting in longer patient recruitment timelines and delays in bringing the drug or device to market and overall increased cost of the trial.
- One of the most valuable results of good training is that site staff become much more conversant in the trial and comfortable talking about it to potential participants. According to Tufts Impact Report for January/February 2024, nearly half of sites in 2023 (47%) either under-enrolled (33%) of failed to enrol a patient (14%) in the trial – the figure has not changed since 2019.
- The same Tufts Impact Report noted that oncology and CNS/neuroscience trials had significantly higher mean numbers of eligibility criteria than vaccines and inflammatory trials making site training even more important to ensure the right patients are enrolled.
The impact of poor training, extends beyond compliance and has the potential to affect recruitment.
Considerations in choosing a comprehensive site training solution
- Choose a training solution that is fit for purpose: Training site staff is different from standard in-house business training on applications. The solution should be developed by a multi-disciplinary team of clinical trial specialists in collaboration with e-Learning, graphic design, and quality professionals. The clinical trial experts will understand the mindset of site staff and be able to understand and address issues facing clinical trial professionals on a daily basis.
- Make access easy: Site staff are busy, and their priority is looking after the patient. it’s important that the access you provide to staff is user friendly and role based to avoid difficult navigation and excessive scrolling.
- Ensure training is specific to the study: Proving non-necessary or general training will frustrate site staff. Make your training as specific to the study as possible. For example, study-specific protocol training designed to improve understanding of the protocol and improve study compliance and facilitate quality learning with self-paced, interactive lessons that optimises user engagement and learning retention through streamlined information, intuitive navigation, and a combination of 2D and 3D graphics.
- Provide just in time options to ensure staff are up to date as the trial progresses: Make it easier for site staff by providing visit by visit, detailed instructions on how to conduct study visits and conduct procedures in compliance with the protocol. It empowers sites in the study to execute study visits more consistently and accurately, thereby driving down deviations.
- Deliver training that supports staff to meet study timelines such as patient recruitment: For example, providing training on how to pre-screen patients will support site staff to ask the right questions and facilitates the identification of patients that may be potentially suitable for participation in a clinical trial.
- Support site staff to engage patients: Making patient education modules available to site staff will help them to relay key pieces of information relevant to their decision-making in participation and enhance patient retention.
- Ensure technology is compliant with regulatory21-CFR Part 11 compliant.
Contact us to today to find out more about what you need to put in place to reduce risk, increase compliance and enhance quality with a comprehensive training solution.