Case study

02 Feb 2021

Onychomycosis Rescue Case Study


Overview

TFS was selected to rescue a phase 3 onychomycosis study from another CRO that was unable to meet the recruitment expectations of the client. TFS provided full CRO services for this study, which was a multi-centre, randomized, two-armed, parallel group and evaluator-blinded study of efficacy and safety of a topical treatment for mild to moderate distal subungual onychomycosis.


    Challenges

    • Site transfer to TFS was slower than anticipated due to protracted contractual negotiations
    • Recruitment was halted during the transfer of sites from the previous CRO to TFS
    • Vendor contracts needed to be renegotiated rather than just transferred to TFS
    • The protocol was of a very challenging design that had been developed without Key Opinion Leader (KOL) input. This significantly affected the delivery of the study. In order for each patient to be enrolled in the study three separate criteria had to be met:
      • Visual diagnosis conducted via a vendor: a photograph of the nail was taken, sent to a blinded assessor KOL, who assessed suitability for inclusion on a pass/fail basis
      • Laboratory diagnosis: a sample of the nail was sent to a central mycology laboratory to test for fungal growth
      • Microscopy: to confirm presence of fungus
    • Considering all three factors needed to be positive before a patient could be enrolled, there was a very high screen failure rate, 3500 patients screened to enrol only 450 patients. This affected the morale at sites and was a key factor in sites deciding not to continue with the study, as their contracts did not include payments for screening
    • The success of the study was also reliant on the efficacy evaluations included in the protocol. However, the fungal growth evaluations selected for this study by the client are inherently inaccurate, and are associated with a 30% false negative rate
    • Patient recruitment was very challenging, despite this indication being very common, since it is an indication/condition often disregarded or overlooked by patients. Sites generally do not have databases of patients with this condition to draw on, and enrolment relies on taking appropriate steps to advertise the study and its benefits, and to engage patients. The client had engaged a recruitment vendor to assist with recruitment activities, and they focussed on leveraging social
      media to locate patients. Not one patient was enrolled as a result of the €200,000 investment in social media campaigns on Facebook, Google and other social media outlets

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