Whether by choice or by force, when things change and those changes make things simpler, they tend to stick. I firmly believe that on the other side of our current global challenges with COVID-19, many of the changes made by regulatory bodies, sponsors, CROs, and sites will be here to stay. In an industry that has been a bit slower than others to receive operational technology with open arms, the wave of tech adoption to enable varying degrees of remote work, collaboration, and oversight will permanently change expectations. Clinical professionals on the ground will have options that reduce their needs to travel or work on-site. CRAs can reduce travel with mobile reconciliation and remote site visits. Sites can upload verified source documents. Document specialists can code documents from home. Clinical trial managers can oversee much of their operations from their mobile devices via dashboards. Teams can receive training by LMS. Regulatory bodies are finding ways to expedite approvals and releasing new guidance regularly. Why would we look backward?
So, let’s continue to look forward. One key milestone at the start of a study is the investigator meeting, where, in some cases, well over 100 professionals may gather from various locations. Since, as a community, we are actively in the process of exploring where we can and cannot go remote, investigator meetings are a perfect example of where there is great potential. There is opportunity for sponsors and CROs to:
- Save significant dollars on the sheer cost of the meeting, meeting planning, and travel logistics and
- Give time and resources back to both investigative site personnel and study team members.
However, organizations are used to in-person investigator meetings being standard practice. It is important to recognize that this would be more than a simple process change. It would be a bit of a cultural change as well. While change can be challenging, we are experiencing realities where it is essential to explore all possible areas to enable remote capability. In a follow-up post, we will talk in more detail about remote investigator meetings. For now, here are five considerations to address the fears about making this change:
- Plan Now – When you find yourself having to make sudden changes it increases the discomfort. In the immediate future, there are many unknowns. If you have a study starting in the upcoming months, consider that there may be travel restrictions and obstacles for large group meetings of any kind. If you are planning to launch a study a little further out into the future, take the current situation as an opportunity to be prepared for disruptions, as we now know it can happen very rapidly and on a global scale. I know. None of what I just said is comforting. How is that helping ease the fear of change? While we cannot control what happens in the world, we can control how we respond. If you have your internal team and/or CRO aligned on the idea of running a remote investigator meeting, you have another means to adapt. Plan right now to have the virtual meeting capabilities in place.
- Make a Good First Impression – My father always said, “You never have a second chance to make a first impression.” For some, this may be the first time you have selected an investigator and study personnel. Perhaps there is a key opinion leader that you want to impress. Whether that is a CEO, chief medical officer, head of clinical operations, etc., making this milestone efficient and engaging can set you apart. Generally speaking, training is often a practice in checking the box with PDFs and PowerPoints that does not engage the investigative staff. By using remote training and conferencing, you have more tools at your fingertips to make the best use of everyone’s time, make it easy, and make it a little more interesting.
- Train Your Vendors – We always tell our sponsor clients that, at the end of the day, regulatory agencies will be judging their operations during an inspection. Establishing good vendor oversight practices from the onset is important to ensure all parties supporting your research are aligned with your culture of inspection readiness. Training is an important component of oversight, particularly whether or not training is provided by the central vendor for investigative sites. In the current climate of limited travel and remote training by necessity, vendors should deliver content that is accurately representative of both the study procedures and your company. These trainings are an extension of your brand. Make sure they adhere to your guidelines when creating content or allocating resources to standardize the training information.
- Lather, Rinse, Repeat – Generally speaking, a certain amount of investigative site staff turnover is expected in the course of a study. This variable already adds complexity in times without logistical obstacles. If your training program is established, with your LMS hosting essential training modules, learning can be readily distributed and accessed . This approach makes it easy to train new staff and eliminates a lot of headaches. Making the training part of your central site collaboration (eISF or site portal) is another way to ensure standard training materials and study information can live as a go-to resource for new site staff, such as study coordinators and subinvestigators. Moreover, prepare for any global considerations by localizing content for investigative site personnel.
- Evaluate and Evolve – Whether you have run several investigator meetings or this is your first foray, it is important to understand what is and is not working for everyone involved. Prepare post-meeting surveys to gather information and refine your approach to these meetings. Get a list of improvements/enhancements and continue to grow so you can create better and better experiences. Attention to this evolution will help you set the tone and inspire the spirit of collaboration for your study.
There is a lot of anticipation and even an industry culture around these investigator meetings. The disruption caused by the ongoing pandemic is a very real pain point. As pragmatists in a world of evidence-based decision-making, it is our imperative to assess the optimal way to proceed, which may fly in the face of tradition. In this case, it is time to challenge ourselves to consider to what extent in-person meetings are necessary or even time-, resource-, and cost-effective. These meetings are a great place to expand your virtual capabilities and, moreover, your ability to adapt to uncertain circumstances. Moving the investigator meeting and site personnel training into a more virtual experience should see reduced challenges regardless of the duration of the current pandemic or in the case of future events.