One of the factors driving the burden of clinical trials is the number and complexity of instruments (including equipment, software or other devices) needed to measure study endpoints. Each of these instruments requires proper set-up and calibration at the study site, staff training and sometimes user certification to make sure the assessments are valid and can be used in a trial setting. This means there’s a significant need to train study site personnel and to ensure they understand how to conduct each of these assessments properly.
The usual way to deliver this training is to run sessions at face-to-face Investigator Meetings held during study start-up. While the vendors who supply these assessments tend to be quite adept at conducting these sessions, there are a few shortcomings of this approach. The most significant issues are timing, since many sites will start the study months after the IM, and the reliance on face-to-face training methods that are difficult to replicate later. Although the sessions can be recorded (video) and the training materials stored (user manuals or PowerPoint), follow-up training for those who couldn’t attend or who need a refresher is often sub-optimal. It’s then left to sponsor Study Managers to figure out which materials to use to fill the gap and how to deliver them. Study Managers are certainly not training experts.
I propose we consider a different way, and ensure that excellent ongoing training modules are also provided by these technical vendors. The content and format could take different forms. Instrument providers know their technology best, including the pitfalls that need to be addressed in training. We should ask them to obtain (or consult with) any expertise needed to choose the best training methods, and then provide modules that can be delivered remotely and to individuals who may be trained long after the IM.
This will be a new expectation and a bigger burden for many vendors. Sponsors and vendors will be concerned about the added scope and expense.
I would argue that sponsors are already bearing both cost and risk either by using stop-gap training methods or, in some cases, by approving additional travel by vendor or site staff to attend remedial face-to-face training sessions. Making remote training modules part of the core expectation of technical vendors is the most efficient way to partner with those vendors to make them part of the solution.