24 MARCH

Successful Phase 2 Obesity Clinical Trial in the ANZ Region for a US Biotech Company

Exceeding Targets for Phase 2 Obesity Clinical Trial 

Overview/The Challenge

PharmaSols was contracted by a small US-based biotech company to conduct a Phase 2 obesity clinical trial. The study required the recruitment of 325 eligible participants across 16 sites in Australia and New Zealand.  

New Zealand has the unfortunate statistic of having the third highest adult obesity rate in the OECD. Therefore, this, combined with over 20 years of experience across Australia and New Zealand, the PharmaSols’ team were chosen as CRO for ANZ.   

PharmaSols was chosen for our bespoke size and for being a well-connected CRO in this region. This can significantly impact the success of a clinical trial and the sponsor recognised PharmaSols for its reputation as a CRO that delivers efficient and flexible solutions within tight timelines and limited budgets. 

Overachieving Recruitment Targets

Through the selection of quality, high performing sites with strong recruitment track records, and meticulous planning and collaboration, we were able to support the first participant-first visit, which was achieved on the same day as the site activation.  

The ANZ region delivered a strong recruitment performance, and after initial global targets were reviewed, the ANZ region recruitment targets were increased to 325 participants, of which 327 participants were successfully recruited all within the study’s recruitment timelines. 

Phase 2 Obesity Trial  

Target.                        Achieved Recruitment 

325 participants         327 participants               101% 

ANZ region delivered 66% of the global target 

Innovative Strategies for Participant Retention

Obesity trials are recognised as high risk for high participant dropout rates. Dropouts occur due to various reasons, such as excess weight loss, lack of motivation, stalled weight loss, loss of muscle, and general study/time commitments. 

Understanding these challenges, PharmaSols, in partnership with the sponsor and sites, implemented creative participant-centric strategies to retain participants and minimise dropouts. These included developing participant support materials, such as an ethics-approved BMI scale for participants to monitor their weight loss, participant reimbursement for phone call visits and DXA visits, and dietitian support throughout the study. 

To implement these retention strategies, the  PharmaSols team needed to manage resubmissions to ethics committees across Australia and New Zealand to get these participant reimbursement strategies approved. Our dedicated study start-up team supported these resubmissions, quickly getting these approvals to support participant retention. 

Successful Outcomes and Strategic Impact

PharmaSols was able to support this small biotech company in running an efficient and effective clinical trial. Our deep and comprehensive service meant that we were able to guide our overseas client team and provide crucial regional support, flexibility, and tailored solutions to ensure that all regulatory and safety/quality aspects were considered and that study milestones were achieved. Our strong partnership with the client assured rapid attention and proactive solutions to any potential issues. 

With all studies, recruitment is a vital component for the overall success of a clinical trial. By delivering an increased participant targets and ensuring high-quality data outcomes, PharmaSols played a crucial role. 

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, study start-up and regulatory compliance all contributed to the study's success.