A focus on investigator initiated trials

In March 2021 a dedicated Investigator Initiated Trials (IIT) team was formed to manage Icon’s growing global IIT portfolio. The appointment of an Investigator Initiated Trials and Grants Manager, Mel Grand, and a dedicated IIT Project Manager, Lloyd Smyth, has reinvigorated the focus of IITs across Icon, aligned processes and supported the establishment of a Group framework to deliver a quality international IIT program.

MEL GRAND

Investigator Initiated Trials and Grants Manager

Mel has over 20 years’ experience in the oncology sector, having worked as a radiation therapist, project manager and clinical trials manager. She brings an extensive depth of clinical knowledge combined with high level project management, including large trial portfolios and the management of government grants, as well as a strong focus on quality and research ethics and education.

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LLOYD SMYTH

Investigator Initiated Trials Project Manager

Lloyd is a qualified radiation therapist who brings experience in both academic and clinical research to the IIT program. He has a strong interest in the use of innovative techniques to treat cancer, having previously completed his PhD in the discipline of radiation biology through work at the Australian Synchrotron. Lloyd’s publication record spans clinical and translational domains, and he brings skills in data and project management to support the development of the IIT portfolio.

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HIGHLIGHTS

• Developed and implemented a new Icon IIT Framework, alongside a suite of resources including policies, procedures, and study management tools to continue to improve the quality of IITs

• Streamlined the use of REDCap as the IIT study base and implemented RealTime Software Solutions to effectively track all trial activities and reporting, aligning the IIT portfolio with the global clinical trials program

• Established the Icon Quality and Sponsor Oversight

Committee (QSOC), providing quality oversight of the

IIT program from a sponsor perspective

• Initiated 16 new potential IITs and 67 patients recruited to Icon IITs • Publications in 2021 include milestone prostate cancer trials focusing on the use of focal brachytherapy and

PET screening:

- Anderson E, Smyth LML, O’Sullivan R, Ryan A,

Lawrentschuk N, Grummet J, See AW, et al. Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution. Transl Androl Urol. 2021

Sep;10(9):3591–603.

- Bowden P, See AW, So K, Lawrentschuk N, Moon D,

Murphy DG, et al. 68Ga-PSMA-PET screening and transponder-guided salvage radiotherapy to the prostate bed alone for biochemical recurrence following prostatectomy: interim outcomes of a phase II trial. World J Urol. 2021 Nov 1;39(11):4117–25.