One of the most time-consuming aspects of clinical trials for sites is training. It’s time to bridge the disconnect between the expected and actual amount of time it takes to train. The 2024 SCRS Technology Site Landscape Survey shows a disconnect between how many hours the sponsor/CRO believed their training requirements were and what the sites reported them to be. Not surprisingly, sites reported more average hours than the sponsors/CRO respondents.
The Site Landscape Survey indicated growing demands for site staff to sit through more and more training, taking valuable time away from all other study duties such as identifying participants. Prior Site Landscape Surveys indicate study staff are subject to an average of 17.5 hours per study per month spent in training. The current Landscape Survey better quantified that by specific roles. On average, each role within a site spends around six hours per month on training, with coordinators often spending even more time.
Prior to the budget finalization, sponsors/CROs should be able to provide a good-faith estimate of the number of expected hours of startup training needed. There should also be a contingency plan for the budget should the training be longer than initially budgeted. All partners are reminded that a training that “only takes three hours” but has to be taken by three people at the site is no longer three hours of site time, but nine hours.
While there is little doubt regarding the need for legitimate training, the focus was more on anecdotal examples of redundancy that are contributing to increased site costs, burden and burnout. Many sites pointed out the mundaneness of watching hours of videos of people filling out sample web-based forms, pointing out the differences between text boxes, drop-down boxes and option buttons as if this kind of data entry was unique to their company.
One site noted they had two similar studies using similar technology, but one sponsor’s training was 4 hours more than the other. Other stories included sites watching several minutes of training on how to set up a username and password when they had to set those up to get into the training system. These examples aren’t one-offs; they have been experienced by sites much more than one would hope.
SCRS is advocating for a 25% reduction in training hours by the end of 2025, a goal that SCRS Honorary President David Vulcano believes is achievable through practical steps. Training should be “right-sized” to eliminate unnecessary duplication and focus on what is truly essential. There are many options to help make this vision a reality:
-
- Allow for Training Reciprocity: Encouraging training reciprocity between sponsors and CROs, similar to what has been done with Good Clinical Practice (GCP) training, could significantly reduce redundancy. If a site took acceptable training for one study, they should be considered trained for the others. Unless there is something really unique about the setup for the particular study, there is no reason that a site should have to take the same or substantially similar train on the same system used in multiple studies. Vendors volunteered that they could assist with this in providing system-specific certificates of training instead of study-specific ones. Sponsors and CROs indicated they could definitely be more cognizant and accommodating of this. Sites indicated they could be more willing to call out when they are being required to do repetitive training.
-
- Focus on Role-Based Training: Sites generally appreciate more modular-based training specific to roles as opposed to general training for all staff. Sites will immensely benefit by only having their recruitment staff take the recruitment training but not the data-entry training, for example.
- Embrace Just-in-Time Training: All parties recognized that training drift is a real phenomenon and that requiring training too early can be problematic. The general consensus was that while much training was essential to be delivered prior to engaging in the protocol, some could be deferred until after the protocol started so that the burden and time required at startup could be decreased. The examples were all protocol specific, but the concept can apply to more content than one thinks.
-
- Focus On Site Needs/Q&A Instead of Pre-made Decks: Sites often complain that they have to sit through site initiation training on things like the lab manual and then are provided with the lab manual to read at some point after the training and then Q&A happens on things the training didn’t address. It is seemingly more efficient to provide the materials for review prior to site initiation and the time can be better focused on the Q&A.
-
- Utilize Pre-training Test-outs: For those who can demonstrate competence in a particular area or with a particular system, should not be subject to training just to “check the box” that they took it. Provide the option to test out and only require the training if they fail to test out or, as always, require retraining later should there be a for-cause issue.
-
- Reduce Unnecessary Retraining: Sites gave numerous examples of how they had to sit through mandatory retraining because of other sites’ mistakes. To solve this, sponsors and CROs can consider more risk-based or targeted “mandatory retraining”. The decision to require retraining should be data driven based on performance at the site or even at the individual level.
-
- Solicit Site Feedback: Sponsors and CROs should actively seek feedback from sites on the usefulness and relevance of training materials, allowing for continuous improvement.
-
- Streamline Training Content: By focusing on essential information and cutting out superfluous content, training can be made more efficient without sacrificing quality.
Given these examples, it should not be a substantial undertaking to cut site training burden by at least 25% in the next 12 months. SCRS challenges sites and industry partners to work collaboratively to achieve this goal.
