At Longboat, we know that to provide great site support, you must seek out and respond to the real-life needs of site staff. As part of this engagement, we hold regular focus groups with site representatives, the main objectives being to:
- Ensure that all aspects of our solution are truly useful for site staff, and actually make it easier and quicker for them to manage their patients according to the clinical trial protocol
- Continually improve the user experience by assessing ease-of-use and intuitiveness – even the most technophobic users must feel at home
- Understand the changing needs of our user base and how we can utilize and improve our clinical technology to support them and “give them time back in their day”
The groups typically comprise of principal investigators, clinical research coordinators of varying experience, as well as site managers and regulatory personnel.
Earlier this summer, we held a focus group with some of the wonderful site staff from PMG Research, a leading network of clinical research groups in the US, facilitated by the experts at the Avoca Group. Here’s a sample of some of the things site staff told us:
1. Protocol, Study-Related Documents, and Source
- Clinical Trial Protocols are more and more complex, with more visits, procedures, and patient populations. Nowadays, sites can only process 1-2 patient visits in a day versus 4-5 ten years ago.
- There is no consistency across sponsors in the way protocols are written and structured – it can often be very difficult to find information. In addition, they’re sometimes unclear and hard to understand.
- Sponsors often rely on the protocol to be an operations manual for site staff, but forget that protocols are primarily regulatory documents and are written as such. Source documents and/or checklists are rarely provided to the sites, and they will often create their own, meaning each site will have different, non-controlled documents as their go-to guides, and the study team will never see them.
- There is a real need for a clear, easy-to-understand, list of instructions for each visit and each procedure.
- In the absence of a clear answer to a protocol-related question, most busy investigators will revert to standard of care, or guess!
- Amendment rollout is not managed in any formal electronic way. Emails regarding a new version of the protocol and associated approvals are often missed.
2. Investigator Meetings and Training
- Perhaps surprisingly, site staff were firmly of the opinion that face-to-face investigator meetings are important for discussion and interactivity. Elements of the meeting could, and should, be replaced by other interventions (e.g. online learning), but the forum itself is valuable.
- Again, perhaps surprisingly, webinars are not a preferred method of training. Attendees are continually interrupted, meaning genuine discussion and peer-to-peer interaction is minimal.
- The principal investigators in particular did however comment that time away from the office was a concern, and rather than the standard two day event, investigator meetings (IMs) could be reduced to one day if complemented with other forms of training.
- There was general agreement that Investigator Meetings should be more focussed and interactive, with key procedures and eligibility criteria covered in more detail, and less time given to more general training, e.g. GCP training that could be done in other ways, e.g. online, via vendor manuals, or by the monitors at the site. They do not want to sit in dark rooms for hours looking at PowerPoint presentations!
- All agreed that online training would be very useful in getting new members of the site team up to speed.
- For the vast majority of participants, communication to and from the clinical research associate and study team was done via email, which is not accurately tracked. These emails have to be printed and filed in the study file, which is extremely time-consuming and unreliable.
- Increasingly, due to the monitor not being available or not knowing the answer, sites were contacting the office-based study team to get information.
- An accessible, current Frequently Asked Questions log with facility to submit a question would be beneficial.
4. Other Issues
- Clinical Research Associate turnover was a concern, with one co-ordinator reporting that she had 14 different monitors over an 8 year respiratory study!
- There was a feeling among the group that they were being asked to do more with less support, and that risk based compliance monitoring was only going to exacerbate this.
Summary: Site Wishlist
- Better, comprehensive, and practical support for site staff
- Clear instructions on how to perform the patient visits
- Tracked study notifications with clear reminders of unread messages
- Face-to-face investigator meetings are important, but should be focussed on patient management, the IP, and key procedures, with less time given to generic and vendor training
- Integration and single sign-on across study applications and websites