Phase II trial: imaging equipment failure

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.

Imaging Equipment Changes
Following the completion of approximately 1/3 of patient enrolment, the site reported that the two PET/CT scanners at their facility had been subject to recall. Due to the nature of the potential equipment failure, neither scanner would be in use until a full evaluation and potential corrective actions had been performed by the device manufacturer. The manufacturer estimated that it could be 3 months before the issues were addressed at the site.
Enrolment in the clinical trial was immediately suspended.

Aixial Group’s solution

The project team at Aixial Group immediately contacted the sponsor to develop a plan for an alternative solution. Aixial Group leveraged its relationship with a known investigator at another nearby facility to evaluate the possibility of providing the required scans using their PET/ CT device.

Aixial facilitated meetings with Subject Matter Experts from the sponsor, the two facilities and the manufacturer to determine if alternative systems could be utilised for the trial. While determination of system and imaging result congruency was underway, Aixial worked with the sponsor to amend the protocol and develop the necessary site-level agreements and contracts for the alternative imaging facility.

At the same time, the Aixial project team led the collaboration of site staff at both locations to facilitate the planning of the scheduling and transportation of clinical trial patients. The team also proactively addressed the potential modification of the shipment and receipt of the radio-diagnostic IP.

Once validation and congruency of the alternative device were confirmed, the Aixial team once again leveraged their site relationships to obtain expedited committee and EC approvals of this change at both centres.

Once EC approvals were in place, a training team was mobilised to the new imaging facility to review the protocol and imaging requirements with that staff. Patient “dry runs” were performed to ensure the processes for the patient journey between facilities were appropriate and would work in realtime.

Patient enrolment resumed within 6 weeks of the initial notification of the device recall. Increased on-site monitoring was performed at both facilities, in addition to the added scrutiny of the imaging results and data.

Despite the enormity and complexity of these circumstances, patient enrolment and completion of the project occurred with only a 22-day delay in meeting the original project timelines