Local know-how gets pivotal breast cancer trial back on track

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When a global breast cancer trial’s recruitment was lagging, Novotech was engaged as the Asia Pacific regional contract research organization (CRO) to help bring the project back on track. Despite a late start and facing rapid start-up milestones, Novotech’s deep knowledge of Asia Pacific saw Taiwan become the 2nd highest recruiting country globally – accounting for 40% of patients to date.

The Background

Due to their complexity, recruitment for oncology clinical trials can be challenging – especially in 3rd line settings where patients who have received standard treatment are often ineligible.

In 2013, a US biopharmaceutical company initiated a global phase III clinical development program for their novel anti-tumor agent to be trialed as 3rd line treatment for metastatic breast cancer.  Multiple CROs were engaged to manage sites across the US, Europe and Asia Pacific to recruit a total of 600 patients globally.

After a delayed site start-up and slow global patient recruitment, Novotech was engaged by the sponsor to takeover clinical management as the regional CRO of up to 32 proposed sites in five Asia Pacific countries – including Taiwan, Singapore, Hong Kong, Korea and Australia.

The Challenge

Despite the change in CRO mid-way through the study’s start up, Novotech was required to meet very rapid start-up timelines.

Our challenge was to expedite a seamless transition as the new CRO, while liaising with two other global CROs who were also providing clinical services and a further CRO responsible for all regulatory matters, globally.

Our actions

Operational agility and efficiency – along with deep local industry knowledge of Asia Pacific countries and strong relationships with sites, enabled Novotech to quickly come up to speed as the regional CRO and improve patient recruitment.

We proposed and implemented a new customized project team model, adding a locally based ‘Asia Lead Project Manager’ role to forge closer working relationships with the four Asian Country Operating Managers, sites and regulatory CRO.

The Results

Despite starting well behind the US and Europe, Taiwan is now the 2nd highest recruiting country globally – accounting for almost 40% patients to date.

The sponsor is impressed with Novotech’s contribution and has also directly praised the valuable contribution by a highly dedicated CRA in Taiwan - which has helped get this project back on track to meet critical clinical development milestones.  

Our feasibility team continues to especially focus on identifying new and supporting existing sites in Taiwan, due to their high enrolment activity to date and potential to recruit eligible patients.