Imaging Agent Surgical Resection Brain Tumor

Study at a Glance Challenges for patients

Risks of Single-Center, Critical Path Clinical Trials
Utilising a single experienced study site for a key clinical trial can be a practical decision when experienced and reliable study staff, required equipment and adequate access to a suitable patient population are in place. Unforeseen circumstances and events, however, can threaten the completion of such a trial.
Site Relocation
The neurosurgery site moved to new facilities shortly before project started up. The new site location was not validated for use in clinical trials or first in human studies. This resulted in a DKMA inspection announcement.
Sponsor and Site Relationships
The sponsor had a very close relationship with the site often visiting the site without notification, driving operational decisions and with limited to no communication with CRO team members. This led to site confusion and missteps in process flows.
Imaging Equipment Changes
During Phase I, two camera brands were used. Following completion of approximately 30% of patient enrolment, one camera brand was identified as being optimal and determined to be the single-camera brand option for Phase II of the project.
Multi-phase protocol and database approach
With a successful Phase I, the protocol was amended to formalise Phase II. The Phase IIportion of the trial had two challenges 1) significant differences from Phase I and 2) the sponsor required Phase II to be in a separate database.

Aixial Group’s solution

To mitigate single site risks and assist in meeting enrolment timelines, Aixial recommended and justified the opening
of a second location in a neighbouring country. Aixial completed the activation of this additional site through qualification, training and ongoing site management resulting in achieved enrolment objectives.

Aixial supported inspection readiness preparations at the site plus supported the site in addressing audit feedback (no critical findings). All findings were addressed in a very short time and the site was ready to recruit within a few days following audit closure. Aixial understood the client’s need for trust.

To mitigate the communication challenges, Aixial proactively reached the sponsor about site engagements and communications on a set schedule. Aixial implemented a project RASCI to also support operational decisions and site interactions.

Aixial assisted the sponsor in the completion of the protocol update related to single-brand camera use. Additionally, Aixial managed administrative elements of site training, patient coordination and documentation updates in an audit ready-manner.

Aixial provided significant clinical, statistical and data management input into and sponsor guidance during Phase II protocol development. The updated protocol was accepted by regulators.

Other project successes

• Routine positive feedback from the client on Aixial project team performance.
• Database lock two weeks ahead of time and following short notification from the client.
• Aixial managed closing the Trial Master File within planned timelines despite project team turnover at the sponsor.