Ten Things Clinical Research Sites Told Us

Posted by Heather Pitt on Feb 7, 2017 2:48:17 PM

Clinical research site staff are fundamental to the success of any clinical trial and are the people responsible for managing their patients in accordance with the protocol while also ensuring each one has a positive trial experience. Therefore, engaging and supporting site staff is critical.  

To better understand the day-to-day demands on site staff, Longboat holds regular focus groups to get their thoughts on taking part in clinical trials.

Here are ten things site staff told us: speak out.png

  1. 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.

  2. There is a lack of consistency across sponsors in the way protocols are written and structured – it can often be very difficult to find information. On top of this, 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, which the study team will never have seen. There is a real need for a clear, easy-to-understand, list of instructions for each visit and each procedure.

  3. In the absence of a quick and clear answer to a protocol-related question, most busy investigators will revert to standard of care, or guess. An accessible, current ‘Frequently Asked Questions’ log with the facility to submit a question would be beneficial.

  4. Amendment rollout is not managed in any formal electronic way. Emails regarding a new version of the protocol and associated approvals are often missed.

  5. Site staff were firmly of the opinion that face-to-face investigator meetings are important for discussion and interactivity with peers. There was general agreement that an investigator meeting should be more focused and interactive, with key procedures and eligibility criteria covered in more detail, and less time given to more general training (e.g. ICH GCP). Replacing elements of the meeting with other interventions (e.g. online learning) would free up time for such engagement. Site staff do not want to sit in dark rooms for hours looking at PowerPoint presentations!

  6. For the vast majority of site staff in the focus groups, webinars are not a preferred method of training delivery. Attendees are continually interrupted, which disrupts learning, and genuine discussion and peer-to-peer interaction is minimal.

  7. Online training would be very useful in getting newly joining members of the site team up to speed quickly.

  8. For the bulk of site staff in the focus groups, communication to and from the monitor 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 sites find time-consuming and unreliable.

  9. Turnover of monitors was a concern, with one site coordinator reporting that she had 14 different monitors over an 8-year respiratory study!

  10. There was a feeling amongst the participating site staff that they were being asked to do more with less support, and that risk-based compliance monitoring was only going to exacerbate this further.

This feedback highlights how we must approach clinical trial execution with a team structure in mind, ensuring that the voices of all stakeholder groups are heard in order to address their specific challenges and support them to achieve optimal compliance and ultimate study success!  

Study Manager Secret Weapon