Clinical trials are often large, unwieldy beasts asking for time from already pressured NHS, or other healthcare sites. Though they are asking important and interesting questions, the needs of each trial, and its participants, must be shouldered with other trials and clinical care.
One of the most undervalued aspects of running a successful clinical trial is the way Trial Managers communicate with their sites. And this is where they can really help to make the trial a success.
A Clinical Trial is much like a large event, and managing it is not dissimilar at its heart. Everyone working on it has their own jobs and areas of expertise, the trial manager works to make sure all of these people can do their work effectively in concert. This works smoothly when everyone knows what’s expected of them. From a trial management point of view, I think this boils down to 3 key things:
1. Lines of communication
- Site Initiation Visits can be a lot of information all at once, and often the only contact you have with many people at site. Ensure you give them punchy take-home messages and a way to catch up on information they may have missed, or to re visit later.
- Letting sites know how to get hold of you, and making sure they know that contacting you is not a problem. Some sites are happy drop and email, but a phone number can be vital for urgent queries or complex issues.
2. Manage expectations
- Some sites may have had more research experience – NINJA was often the first plastics trial in many of the sites I opened. The set up for each speciality and the coordination between the clinicians and research staff will differ by site. Having them figure out the best way to work together locally, who else they might need to be involved from the various patient pathways means that not only are they helping the trial reach target, they are creating structures and processes for future trials at their sites.
- Ensuring the research staff know what is expected of them: i.e. which documents are sent where and how, what data they are responsible for entering, what participant time points are followed up at site or centrally etc.
- If your working pattern is not a typical office-based 9-5 workday, pop a note in your email signature specifying your typical hours and upcoming leave. That way you can set the boundaries for when sites can expect a response.
3. Be open to feedback
- Delivering information succinctly, to be understood clearly by all is super important. That onus is on trial managers to deliver it well, clearly and to allow people to question what they don’t follow. It’s important to ensure that sites feel they are able to ask questions, even if they seem like something they should know already. Reassurance is a valuable tool!
- Feedback from sites and participants can help streamline processes and clarify documents at all stages in the trial. Of course, some things may not be possible to implement in the life of the trial, but these can be learning points and things to take forward.
Every trial is unique in how it works. By being clear, ensuring everyone knows what is expected of them, and listening to feedback, trial managers can keep things running smoothly with sites and learn new skills to take forward, not only to help future trials, but also to develop in their careers.