A recent study found that 72% of investigators cited “finding time to devote to other (clinical) work [activities]” had a major or moderate effect on their decision to no longer conduct FDA-regulated drug trials. The way in which you support investigators can influence everything from their compliance with protocols, how well they recruit patients, to the way they engage with trial participants and whether they’ll work with you again. Your ongoing trial success begins and ends with your site staff. So how do you keep them on board?
Longboat holds regular focus groups with site staff to get to the heart of the issues that they face. We’ve consolidated those insights into three easy rules of engagement that can fast-track you to study success.
1. Keep study information simple
Every trial comes with unique challenges, a mass of paperwork to complete, and lengthy documentation to digest. Up to 90% of staff at sites are mixing their role in research with their main clinical role. This means there are multiple pressures on their time, and lengthy documents are unlikely to help.
We’ve been told that information needs to be easy to understand and that, although protocols are official regulatory documents, they’re not always the best or easiest thing for them to use on a day-to-day basis. It’s like trying to read an entire novel, when all you really need are the cliff notes.
The increasing complexity of large-scale trials means that sites are only able to process 1-2 patient visits a day compared to 4-5 just 10 years ago. There is a real need for a clear and easy-to-understand list of instructions for each patient visit and each procedure.
This means stripping the protocol information to its essential pieces. Only the most vital information to do the job properly needs to be there. In one of our focus groups, 100% of contributors believed web-based instructions, accessible on phones and tablets, that provide just this type of information would dramatically reduce data queries and protocol non-compliance. And, not only does this make the process simpler, it offers a slick experience too.
The benefits of making trial information simple extends beyond site staff. A site team that truly understands and engages with your study is far more likely to be able to engage patients to join your trial. It’s an easy way to boost your site team’s motivation and your recruitment numbers too.
"86% of focus group contributors believed web-based technology, providing training, visit instructions and documents, would improve the conduct of their trials by removing the burden on staff."
2. Keep Resources in a Single Repository
Clinical research sites tell us that it can often be very difficult to find information. Source documents and/or checklists are rarely provided to the sites, and they will often create their own.
One solution is to provide a single, centralized and accurate source of information. That way, it’s easier for site staff to find the information they need quickly and efficiently on-demand without having to rifle through multiple sources.
Poorly executed trials start at poorly prepared sites. And if a centre isn’t supported to find their way through the deluge of trial information, especially in the early days of set-up, it can lead to frustration.
The easier you make it for sites to find what they need when they need it, the more likely you are to have better site set-up, performance, and ultimately a higher chance of sites wanting to work with you again in future.
3. Build an ongoing two-way dialogue
It might be easy to pop in and see how a site down the road is doing, but how do you keep sites that are hundreds, even thousands of miles away engaged? With too little support, site staff can disengage and are certainly not likely to sign up to support your trial the next time around.
Working together to set up the trial can help you to anticipate any site-specific issues and establish agreed ways of working upfront. Look for ways to establish a two-way dialogue that can continue throughout the study, and harness technology as your helping hand to make regular interaction possible.
“It may be necessary to implement alternative training (e.g., teleconferences, webcasts, online training modules) and communication methods for providing and documenting ongoing, timely training and feedback, as well as to provide notification of significant changes to study conduct or other important information.”
Site staff tell us that a simple way to submit questions to a FAQ log would be beneficial and help to increase compliance. And if you do have precious face-to-face time with your sites, use it well. We’ve heard that site staff would rather have more focused and interactive discussion with peers, rather than general training on clinical research procedures, which can be completed remotely. Many will be interested in the science of the study and it’s a great way to build that sense of ‘team’ that is so important to a trial’s success.
Engaged sites lead to engaged patients
The experience of your site staff will have a direct impact on the experience of the patients on your trial too. It plays a fundamental role in whether you can hit recruitment targets and is essential for retaining participants until the end of the study. The more engaged your site staff are, the more engaged your patients will be too.