Reducing the costs of phase III cardiovascular clinical trials

Background The pharmaceutical industry spends not, vert, similar$26.4 billion annually for research and development ($4.1 billion in cardiovascular products). We compared pharmaceutical companiesʹ planned resource use and costs in Phase III cardiovascular trials and identified cost-saving strategies. Methods and Results We developed 2 case scenarios (a 17,000-patient, open-label acute coronary syndromes [ACS] trial and a 14,500-patient, double-blind congestive heart failure [CHF]) trial and surveyed 6 pharmaceutical experts about expected resources (e.g., number of sites, case report form [CRF] pages, and monitoring visits) needed for the trials. Using a validated model, we estimated costs under each expertʹs assumptions. ACS trial costs averaged $83 million (median, $67 million; range, $57 to $158 million) and $142 million (median, $135 million; range, $102 to $207 million) for the CHF trial. Site-related expenses (site management and payments) were >65% of total costs for both trials. In sensitivity analyses, total costs were reduced >40% by simultaneously reducing CRF pages, monitoring visits, and site-payment amounts but maintaining the numbers of patients and sites. Conclusions With a set number of sites and patients, the most efficient way to reduce trial costs and still meet the trialʹs scientific objectives is to reduce management complexity. Modest changes in management parameters release significant monies to answer more research questions.