Increased compliance for complex Alzheimer’s disease study

The sponsor in this case was a large pharmaceutical company that contracted ICON to manage and streamline the training and compliance workload for their phase 2 Alzheimer’s study. The study required complex protocol that governed 230 sites with 272 total patients and included a significant volume of training to be completed, tracked and reported.

Running a study with a sensitive patient population of individuals aged 60-80 dispersed across 230 sites includes significant challenges. The sponsor was concerned with site adherence to protocol, explicitly relating to training, resource access, and patient experience.

The study required substantial detailed training, including some rater training, and the sponsor wanted to provide staff with the ability to revisit training as needed. It was also essential to provide access to training for any potential amendments and additional support modules for the study. Another challenge was to create a simple means for the team to distribute specific documents in a targeted way.

The patient population’s advanced age required additional considerations, and the sponsor was keen to ensure patient visits were efficient and stress-free. The study required ready access to information, documents and resources to diminish risk and maximise the positive patient experience.

The FIRECREST production team developed a system for the sponsor to track training compliance in real time and give ready access to completion records. They analysed and identified risks in the protocol and then designed a protocol overview training to ensure all sites had proper access.

Next, they created a visit-by-visit guide for the staff to track the preparations required for each visit. This guide included details for the necessary procedures for that visit and sets of instructions for the patient/ caregiver before the next visit.

The study team could access, complete and track training through the FIRECREST study-specific portal. The portal housed TICS-m Rater Training, training for plasma collection for p-Tau testing, Handling Investigational Product, Data Management and specific training for staff in Talking About Suicide with Clinical Trial Participants. The portal also housed compound, central lab and MRI overviews readily available to staff. For those documents that needed targeted distribution, TrialDrive was added to the portal to efficiently distribute selected documents to specific roles, countries or sites.

After implementing the FIRECREST system, the sponsor reached their goals for training and their document records were always accessible in real- time at training, study, site and individual levels. The study showed strong training completion figures with a total of 13,973 training completions across 3,100 users with increasing completion rates for the study’s key roles.

Principal investigators tracked at 92% completion, 95% for site staff and 88% for raters.Consistent use of TrialDrive document distribution facilitated the easy access of important study and site-specific documents through the portal. TrialDrive hosted 165 published documents and tracked more than 16,000 document views.