The Cure for Protocol Deviations and Non-Compliance? Ask a Doctor!

Posted by Karen McIntyre on Nov 11, 2016 4:26:37 PM

SUPPORTING THE SITE STAFF SUPPORTS THE PROJECT TEAM AND DELIVERS YOUR TRIAL!

46% of all investigator deficiencies in clinical trials are due to non-compliance. This shocking statistic has not changed in two decades. Our industry has advanced in so many ways in that time, and yet despite the best intentions of all involved, we’ve created an environment where it is difficult to ensure the instructions in the protocol are followed by highly intelligent professionals.

So why is this the case? Doctors and nurses want to participate in clinical trials; they want to do a good job.

When kicking around this topic with my industry friends and colleagues, the same themes cropped up again and again:

• Lack of resource

• Lack of time

• Need to prioritize day-to-day clinical care over the study

Clinical Compliance

We all recognize these barriers. 90% of investigator sites (40% of which are likely to be participating in their first clinical trial) are mixing research with their primary occupation - the clinical care of patients.

Longboat hosted a series of focus groups to better understand what site staff think. We invited doctors and nurses who all had some experience conducting clinical trials, some extensive and some limited.

Consider the journey of a clinical-trial-naive doctor turned investigator. On successful completion of the feasibility report, the investigator learns the site has been selected. Great news! However, this is the beginning of a daunting journey before the trial even begins - contract negotiatons, multiple documents to be completed, returned, copied, filed, etc. Then, the huge volume of stores arrive for which a home must be found – typically a store room a significant distance from where patient visits are conducted.


“PATIENT ENCOUNTERS ARE NOT ALWAYS IN THE SAME LOCATION - FIRST FIND THE CONSULTING ROOM AND THEN FIND THE EQUIPMENT.

Study Coordinator, USA


Some months before the study is due to begin, attendance is requested at the investigator meeting. The site staff tell us that, while these meetings are valuable, they believe a more interactive workshop-style format would be preferable to the more typical PowerPoint-heavy approach. 4 months and 160 consulting clinics after the investigator meeting, the first patient is due to arrive...... Site staff know what the study is about and why the study is being conducted. What is not so easy to recall is:

• What equipment do I need?

• What do I need to do (procedures)?

• How do I do it?

• Are there different cohorts or sub-studies?

• Should some subjects be treated differently


“IT IS DIFFICULT TO RECALL FINER DETAILS OF THE PROTOCOL.”

Study Coordinator, UK

 

“PROTOCOLS ARE COMPLEX WITH LOADS OF FOOTNOTES.”

Study Coordinator, USA


 This may come as a shock to the project team who carefully, and at great expense, provided reference manuals including the protocol, lab manual, ePRO instructions, pharmacy manual, eCRF completion guidelines, etc.


“HOW CAN I ENSURE THE TEAM ARE WORKING TO THE CORRECT PROTOCOL VERSION?”

Study Coordinator, UK


 Supporting the site staff supports the project team and delivers your trial. Preparation for, and the conduct of, the visit requires access to the study documents stored in a locked cabinet (assuming that the last person to use the documents returned them and that they’re the most current approved versions!)

Reference to multiple manuals is simply not practical; it is stressful and causes errors & misunderstanding, and results in protocol deviation and reduced clinical compliance. 100% of the focus group contributors believed web-based instructions, accessible on phones and tablets, providing consolidated instructions for each specific study visit, would dramatically reduce data queries and protocol non-compliance.

Protocol Training

At Longboat, listening to the doctors and nurses responsible for delivering clinical trials has helped us to design a solution that overcomes barriers and improves site performance by guiding compliance, creating a “site champion” on every study for every visit.

Supporting the site staff supports the project team and delivers your trial.

Study Manager Secret Weapon