Successful Phase 2 Obesity Clinical Trial for a US Biotech Company?

Exceeding Targets for Phase 2 Obesity Clinical Trial???

Overview/The Challenge??

A US-based biotech company was conducting a Phase 2 obesity clinical trial for a lifestyle/metabolic disorder compound.???

The study required the recruitment of 450 participants across Australia and New Zealand. These were spread out over 16 sites, presenting a logistical challenge in managing and coordinating the various sites. The initial target timeline for recruitment was 5 months.??

To support their study, this biotech company engaged with HiRO ANZ.???

The team at HiRO ANZ leveraged our strong relationships with partners and investigators to ensure a smooth and efficient study execution.??

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Rapid Start-up and Overachieving Recruitment??

Through strategic planning and collaboration with the sites to initiate pre-screening, we were able to quickly achieve site activation. HiRO ANZ immediately initiated the first-patient first-visit on the same day as the activation.???

HiRO ANZ successfully achieved the initial target of 450 participants within the 5 month recruitment period. After these results, the sponsor increased the target to 495 patients and extended the recruitment period to 7 months.???

Despite the large scale of the study across multiple sites, HiRO ANZ successfully enrolled 324 participants across both Australia and New Zealand, surpassing the target by overachieving in New Zealand:??

New Zealand participants:??

Target: 205??

Achieved: 220??

Australia participants:??

Target: 120??

Achieved: 104??

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Innovative Strategies for Patient Retention??

Throughout the ongoing study, HiRO ANZ implemented creative strategies to retain participants and minimize dropouts. Dropouts in this study occurred due to various reasons, such as excess weight loss, lack of motivation, stalled weight loss, loss of muscle, and general study/time commitments.??

To address these challenges, the team submitted a BMI scale ($100), which was approved by ethics to be handed over to patients when they enter the extension period.???

HiRO ANZ also submitted patient reimbursement ($200) for phone call visits and DXA visits, which were not included in the original ethics submission but were subsequently approved.??

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Successful Outcomes and Strategic Impact??

By overachieving recruitment targets and ensuring high-quality data outcomes, HiRO ANZ played a crucial role, not just in the study itself, but also in supporting the US biotech in getting acquired by a larger pharmaceutical organisation.???

The efficient execution of this Phase 2 clinical trial in the Australia and New Zealand region reflected our strong capability in managing large-scale, multi-site studies while delivering exceptional results. Our expertise in project management, site selection, participant recruitment, and regulatory compliance contributed to the study's success.??