Training issues commonly differentiate successful from unsuccessful studies. During a recent project, I heard this from a Manager of Study Coordinators:
“Each of our study coordinators is responsible for six or more studies. When a coordinator is not sure of what they need to do for each visit, they will find a way to make patients ineligible for that study.”
Together, one of our jobs is to minimize avoidable investigator site staff rejection of study subjects. Training is a major part of that. Based on our database from more than 400 studies, five of the 31 issues predictive of ‘success’ vs ‘non-success’ of clinical trials relate to training issues.
So, here are three recommendations to improve site staff training:
1. Provide specific protocol-related training
Your training should be designed specifically for your protocol. When training is too general, your study is less likely to randomize the targeted number of patients. I can’t tell you the number of times I’ve had coordinators express their frustration to receiving training using a generic lab kit. This is condescending and a waste of their time. How many coordinators don’t know how to handle a generic lab kit? Instead, what they need, and want to know is how to handle your specific lab kits for each visit.
Similarly, when being trained on hardware, coordinators should be instructed using the actual hardware. They should be trained on how to use it, how to handle routine issues such as replacing paper, loading cartridges, etc.
2. Select the best channels of communication
Webinars and web-based training can provide significant cost savings and has a role in clinical trials. However, think of what you do during many webinars/web-based training. Are you paying close attention, or are you multi-tasking? When training is important, it should be conducted face to face. Web-based training is appropriate for GCP and other routine training programs. Most investigators and coordinators have been exposed to GCP training numerous times. Web-based training, when well-constructed, can help them focus on one or two unique issues important to your company/project.
Training that is critical to your trial should be conducted face-to-face. It can be at investigator meetings, during SIV or at booster meetings.
3. Target training to specific audiences
Target specific audiences. Investigators have different training needs than coordinators, who have different needs than patient recruitment specialists. While it may be tempting to develop training focused solely to address specific issues without considering the specific audiences, the results of doing so will be lower quality training, and more challenges in your trials.
Contact me at 610-256-5623 if you have any questions.
Ross H. Weaver, PharmD, MBA