Last month, Pharm Exec, the Tufts Center for the Study of Drug Development and software vendor Clear Trial brought companies together for an editorial exchange on current challenges in budgeting and spend for clinical trials. The exchange, which is published in this month’s issue of Pharmaceutical Executive, highlights the emergence of efficient trial management as a strategic priority for management in bending the cost curve on bringing new innovations to market.
Read on for the five key conclusions representing the group consensus.
(1) The complexity, population heterogeneity and global scale of trials today is making it harder to control for unexpected developments that require amendments to trial protocols — amendments that cost time and money.
(2) Cost of drug development overall and the longer lead times imposed by regulatory fiat means that management will no longer tolerate wide variances in the cost of trials against what is budgeted – predictability in spending is key.
(3) Tufts Center for the Study of Drug Development research shows multiple changes to trial protocols, often at the late stage of trials; wide discrepancies among surveyed companies in where budgeting responsibilities are housed; and bewildering contrasts in the kind of tools utilized to manage the spend on trials. The result is continued bias toward fragmentation and silo thinking at a time when management is demanding more accountability for results.
(4) Companies are still grappling with how to apply advances in expense tracking technology and software to promote seamless integration of data that can anticipate and correct for cost exposures during the conduct of trials. Commonly used metrics of financial performance often work poorly when applied to a trial setting; new ways of measuring results on a consensus basis are required.
(5) Solutions to the budgeting challenge include more joint planning, departmental coordination and integration, applying learnings from other functions and industries; and building better ties to patients, particularly as the protocols that drive budgets are designed and implemented in the field. More collaboration to promote understanding by the main regulatory agencies of the cost curve is also important.
For the full report on the debate, click here.