Saving the heart failure

ProjectPharm and Pharmaplex were approached to rescue a study in heart failure. The study was originally to recruit 780 patients with heart failure, and had been placed with one of the top 10 tier CROs.

The CRO anticipated 1 year for the recruitment. At the moment of this intervention, recruitment had been open more than 18 months, and 67 patients had so far been included, which means that the actual recruitment rate was at 6 % of the estimate. The CRO had submitted two change requests for completing the study, anticipating a prolongation of 7 / 8 years and a budget overrun of approximately 400 %.

ProjectPharm and Pharmaplex accepted the challenge of rescuing the project. The mission was to complete recruitment in no more than 1 year (due to a deadline imposed by a competent authority) and contain the budget as much as possible.Finally, recruitment was completed with a slight over-recruitment of 33 patients 9 months and 15 days months after the start of the rescue project; the final cost was within the anticipated limit of 200 % of the original budget.

This could be achieved only by involving a series of smaller, local CROs, acting – together with the original CRO and its respective vendors, with Pharmaplex being responsible for scientific and regulatory issues, and with ProjectPharm being responsible for coordinating and leading the project as a whole, i.e. a virtual CRO, acting as one team across a relatively wide geographic area.