Counting the Cost of Corrections in Clinical Trials Labeling

Journal of Clinical Studies

The cost of bringing new drugs to market has soared, not least because of rising regulatory requirements. New analysis published earlier this year by Tufts Center for the Study of Drug Development (Tufts CSDD) puts the bill for developing and gaining marketing approval for a new drug at over $2.5 billion, climbing to $2.87 billion when post-approval R&D costs (of $312 million) are factored in.

The $2.5+ billion figure (per approved compound) is based on estimated average out-of-pocket costs of $1.4 billion and time costs (expected returns that investors forego while a drug is in development – typically many years) of $1.16 billion. That’s before any cost for postapproval studies, required by the US FDA as a condition of approval, to assess new indications, new formulations, and new dosage strengths and regimens, and monitor safety and long-term side-effects in patients.

Maximising Trial Success Despite the Odds

Within all of this, the clinical trials process carries its own particular share of risks and associated costs. If drugs do not pass human testing – and most don’t – all of the work that precedes this will have been for nothing: certainly it will not deliver the expected return. So life sciences companies need robust processes in place to ensure that products are taken absolutely correctly, leaving no scope for error in dosage, for example.