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Turning rapid study start-up into enrollment momentum
This case study explores how coordinated planning across clinical operations, IP supply, and labs helped a large global rare cardiovascular outcomes trial reach critical start-up and enrollment milestones ahead of plan.
A midsized biotech focused on complex therapeutics for rare diseases was undertaking one of the largest global Phase III cardiovascular outcomes trials in transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a rare, progressive disease in which abnormal protein deposits build up in the heart and impair its function. The study required start-up and enrollment across approximately 280 sites in 37 countries, with a target of 1,750 patients and a footprint nearly twice the size of the sponsor’s prior programs.
Identifying and recruiting patients for rare diseases such as ATTR-CM can be challenging because of the small eligible patient population. In this case, recruitment was further complicated by the increasing availability of commercial therapies.
These recruitment challenges, combined with the scale of the global site network, created significant pressure across regulatory start-up, site activation, and enrollment. To accelerate start-up and build enrollment momentum, Thermo Fisher Scientific coordinated regulatory, clinical supply, laboratory, and clinical operations activities through an integrated delivery model. This approach established shared priorities and early visibility across feasibility, site selection, regulatory submissions, supply planning, and site activation.
From faster site activation to enrollment ahead of forecast
Download the case study to explore the results of Thermo Fisher Scientific’s approach, including:
- First site activated 3 days ahead of plan
- First subject screened 6 days ahead of plan
- 50% enrollment achieved 8 months ahead of plan
- Monthly accrual rates consistently 3–5x above plan
