Site monitoring represents minimally 15% of your total clinical study budget, and concerns an expense that benefits enormously from digitization and evolving regulatory insights: Electronic data capture and querying, online study training, remote monitoring, and risk-based monitoring, and makes you wonder whether it is still necessary to have on-site monitors?
The number one reason for the on-site monitor is proper source data verification, i.e. the process to ensure that data are verifiable, correct, and complete. In spite of electronic means, such as EDC and remote desktop sharing, there are certain things you can only verify when on-site. On-site monitors review unselected hospital files in their own way and at their own pace with less security and confidentiality issues, often identifying valuable data a site study coordinator overlooked.
Although internet based training tools are of great help (re-)training a site study team, there is nothing more efficient than a face-to-face training with in person interaction. Whereas on-line trainings can be rushed, there is no escape from a person sitting next to you and providing – hands-on – instructions and asking questions. Especially in medical device studies, where adequate training is key to a successful study outcome (also refer to an earlier blog of mine) and patient safety, the impact of on-site and hands-on training should not be underestimated. In case of an investigational medical device
Less tangible, but ever so important is that on-site monitors do more than source data verification and clinical study (re)training – they achieve much of the improvements in data quality through repeat personal contact. This involves maintaining good relationships with the entire site study team, which includes more than the study coordinator, and is something which nearly impossible to do from a distance and at a fixed point in time. Experienced monitors also develop their own network and useful contacts for future clinical projects.
Principle investigators are responsible for the implementation and management of the day-to-day conduct of the clinical study, as well as the data-integrity and the safety of the study patients at his/ her site, and as such needs briefing on a regular basis, especially in case of issues. Because of their busy schedule and priority with patient care, such typically does not work very well by sending a written report or requesting presence during a remote monitoring visit. Regular on-site presence with the flexibility to brief the principal investigator at any moment when there is a – sometimes unforeseen – gap in his/ her calendar works a lot better in this respect.
No matter how cost-effective remote monitoring and querying via EDC may seem, there is no substitute for the human touch in many interactions for the clinical study execution at a site. Knowing that much of communication is non-verbal, it is not surprising that many site study team members prefer dealing with a person face-to-face and in their own language rather than a website, or an overseas data-manager that they have never seen.
Referring to the title of this blog, evolving means and approaches can help to make clinical study monitoring much more cost-effective, but can never replace the on-site monitor as there are too many aspects of this job that need a flexible face-to-face interaction. Not the least in the area of medical devices with a growing need for high quality clinical evidence and with the upcoming revision of the EU medical device directive in mind. The Mastodont may have gone extinct but the elephant still stands …