At the Recent Clinical Quality Oversight Forum, I had a chance to give a presentation entitled “The Path to Successful Remote Monitoring (watch it on-demand).” For me, it was something of a culmination of all the research, interviews, and thinking I have done this year on how sponsors, CROs, and sites can transition to a remote model for study monitoring. One area I’ve spent a lot of time research is the obstacles to remote monitoring.
I probably tried to cover too much in 30 minutes, but my primary goal was to zero in on the obstacles to make the transition and the strategies to address them. I divided the obstacles into four groups: Regulatory, Economic, Technology-related, and Behavioral.
Obstacle 1: Regulatory
On the regulatory front, our survey work indicates that there is concern about whether it is “OK” to do monitoring without an in-person visit. In the United States, the answer is clear and direct from the FDA: they have communicated that it is indeed, OK.
Guidance issued in March 2020 and updated in June, the FDA stated that “If planned on-site monitoring visits are no longer possible, sponsors should consider optimizing the use of central and remote monitoring programs to maintain oversight of clinical sites.”
I was asked about the state of regulatory support for remote monitoring in other countries and jurisdictions. I confessed then and reiterate now that I do not have expertise in that area. Others with more expertise than I have told me the EU position is similar, but you should do your own due diligence if you operate outside the US.
Obstacle 2: Economic
The next category of obstacles to remote monitoring we discussed was economic, that is, that the cost of transitioning to a remote monitoring model could act as a blocker. In the case of sponsors and CROs, the opposite is true because they stand to save substantially – up to 25% — if travel costs are considerably reduced as part of the overall study budget.
Where there is an economic barrier to the transition to remote monitoring is regarding clinical sites. Clinical sites may have increased costs relating to software and systems, and the staff time required to upload documents and communicate with monitors. This is potentially a show-stopper, and sponsors and CROs who want to move to remote monitoring models must be ready to invest in sites to address systems, staff time, and training costs. Sponsors and CROs stand to benefit from a transition, so they need to incentivize the sites.
Obstacle 3: Technology
In terms of technology, there is a perception that there is a lack of solutions to address remote monitoring requirements — 60% of those we surveyed indicated they felt this was a major obstacle. In reality, however, remote monitoring applications and systems exist and are in use across many organizations.
The key in terms of technology is to focus on “fit for purpose,” that is, to choose a system that is specifically designed to support remote monitoring purposes. Simply exchanging files through DropBox or a shared network drive is not acceptable; the process requires more than a shared vault for storing files. “Fit for Purpose” means it supports the full range of monitoring processes from reviewing binder and source documents to exchanging monitoring notes and assigning tasks with due dates to site administrators.
Obstacle 4: Behavioral
In my session, I left the largest set of obstacles — those relating to the transition’s behavioral aspects — for last. They are clearly the most significant challenges, where organizations will have to invest the most time and effort.
Clinical study monitors have been traveling to sites for a long time. It is a known and accepted model, and changing the behaviors of both the sites and the monitors will require planning, training, and incentives.
For the monitors, the change will be dramatic. While we all complain about travel, some of us secretly welcome the change in our daily patterns and the opportunity to expense a nice dinner. Making the transition to a remote model for the study monitors is easier because they are employees and contractors, and the people who pay the bills dictate the change. You still need to do careful planning and training, of course, but ultimately the change will happen.
The biggest obstacle on the behavioral side is with the sites. They are the ones who will be asked to make significant changes in behavior and can create friction and confusion if they are not on board, and they will have to load documents and files into new systems and potentially multiple systems for different studies. They will also have to react to monitoring notes delivered electronically. And study administrators must ensure that their patients’ private information is protected throughout the process.
So it is at the site level where most attention should go when it comes to planning and managing the change to remote monitoring. Establish incentives. Training needs to happen. It’s also important to effectively communicate the benefits of the transition through education and communication initiatives.
Get Started with Remote Monitoring
The place to start is with a site evaluation. Every site is different, but the obstacles to remote monitoring I’ve outlined are things you should identify and prepare for. Some companies will be more ready, and others less ready to make the shift. A scorecard model for assessing site readiness for remote monitoring is a valuable tool, and I have created one. I will tell you more about it in my next post.