The Challenge
Completing this trial end-to-end within one year was an imperative for the client, who was investigating a novel oral treatment in drug-susceptible pulmonary tuberculosis. Micron’s collaborative relationships with high-calibre imaging centres was pivotal to recruitment and retention of patients.
Micron’s Contribution
A Phase IIb/c trial of a novel oral treatment regimen for drug-susceptible pulmonary tuberculosis was planned by the client, and the trial assessments included stringent imaging criteria. Recruitment of patients with tuberculosis can be challenging, and retaining participation of the full quota of 122 patients to assess response to treatment was crucial to the trial’s success.
Prudent selection of eight Investigator sites was complemented by establishing partnerships with accomplished radiologists at leading imaging centres. Conducting the trial presented an array of challenges, including provision of a complex dosing regimen, and multiple visits with a detailed schedule of PET/CT scans. Micron provided medical monitoring, safety management, and had oversight on laboratory testing. Micron also ensured that all ethics approvals and regulatory procedures were timely and compliant.
The Result
This trial’s successful completion within one year, without any loss to follow-up, was built on Micron’s sustained partnership with imaging centres, Investigator sites, and external vendors. Our approach kept patient recruitment on target, and patient retention on the trial was supported by expertly trained site staff. The sponsor’s trial goals were completed on schedule, contributing to the clinical development of a groundbreaking oral regimen that could shorten the duration of treatment for tuberculosis.
Accelerating patient recruitment in a specialised anti-infective therapy area
Within the first month of Micron starting the study, monthly patient recruitment attained the target.
Rapid initiation and agile delivery of a complex Phase I COVID vaccine study
This successful trial was completed when the milestone of database lock was achieved just four weeks after last patient last visit.